Conditions: Anorexia Nervosa/Bulimia Anorexia in Adolescence Anorexia Nervosa, Atypical Anorexia Nervosa, Binge Eating/Purging Type Purging (Eating Disorders) Impulsive Behavior Eating Disorders Bulimia Nervosa Eating Disorders in Adolescence
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 9
Healthy volunteers: no

Brief summary:
The objective of this study is to evaluate the effectiveness of oral naltrexone tablets in pediatric and adolescent eating disorders, in particular anorexia nervosa and bulimia nervosa, as compared to placebo. Study participants will be patients in a partial hospitalization program or intensive outpatient program for eating disorder.

Detailed description:
Subjects participating in this study will receive routine care for eating disorder at a partial hospitalization (PHP) level of care at MSHMC. In PHP, all patients have weekly medical screening visits for the duration of their time in care, as well as weekly individual therapy sessions, individual dietician sessions, and psychiatry appointments. They have supervised meals and numerous group therapy sessions. Every three weeks, patients in PHP complete a battery of mood and eating disorder indices including those evaluated in this study; participants in this study will complete an additional two surveys with this routine battery. Participants in this study will have no alterations in their routine eating disorder care outside of study article use and these additional surveys.

Subjects will be enrolled at their first visit for eating disorder programming at child or adult partial hospitalization (PHP) programming at MSHMC adolescent medicine eating disorders clinic. Informed consent/assent will be obtained as described above.

The subject will be provided with oral naltrexone or placebo weekly from the MSHMC research pharmacy. Subjects will be given one weeks' worth of medication at a time. Subjects will be randomized at enrollment to receive either study drug (naltrexone) or placebo. Participants or parents of minor participants will be provided study drug or placebo following completion of urine drug screen and consent/assent. Patients will take the medication daily for six weeks. For subjects who are enrolled in child PHP and who eat meals with parents, the families may choose to administer study drug during meals at programming. For adult patients enrolled in adult programming, subjects may choose to self-administer the medication.

On their first contact with PHP, all patients in Child PHP complete various eating disorder indices as a part of routine care, including the ED-15, EDE-Q, RCMAS, CDI, GAD-7, and PHQ-9. This battery of indices is repeated every 3 weeks while a patient is in programming.

For those who are enrolled in this study, they will complete their routine indices, in addition they will also complete the BIS/BAS and the ABUSI at enrollment and at weeks 3, 6, and 9 (after completion of medication) while in programming. Participants will receive routine eating disorder care while in PHP.

Patients in Adult PHP typically complete a different inventory every three weeks. If a patient chooses to participate in this study they will be asked to complete the same surveys as participants in Child PHP, and they will receive the same amount and type of compensation.

Six months after enrollment, subjects will be sent copies of ED-15, EDE-Q, GAD-7, PHQ-9, BIS/BAS, and ABUSI indices either in an in-person medical appointment or via RedCap to complete. If the patient returns for medical follow-up between 5 and 7 months after enrollment, their height, weight, and body mass index will also be recorded to determine if weight restoration was maintained.

At initial contact with the eating disorders clinic, all patients receive an initial battery of laboratory tests as a part of the standard of care for eating disorder. These tests include liver function assays and transaminase levels.

Arms:
arm 1: Oral naltrexone, to start as 25mg for three days then 50mg a day for 6 weeks. Oral naltrexone generic tabs will be blinded in opaque gelatin capsules with methylcellulose filler arm 2: Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks

Interventions: intervention 1: Naltrexone Hydrochloride intervention 2: Control
Intervention descriptions: intervention 1: 25mg x 3 days then 50mg a day thereafter intervention 2: Methylcellulose and gelatin capsule only

Protocol document:
Prot_SAP_003.pdf: 
Page 1 of 45 (V.01/21/2019) 
                                                                                       
HRP-592 - Protocol for Human Subject 
Research with Use of Test Article(s)
Protocol Title:
Provide the full title of the study as listed in item 1 on the “Basic Information” page in CATS IRB (http://irb.psu.edu). 
A Double-Blind Placebo-Controlled Evaluation of Effectiveness of Oral Naltrexone in Management of Adolescent Eating 
Disorders
Principal Investigator:
Name: Rosemary Claire Roden, MD
Department: Pediatrics
Telephone: 717-531-0003 x 282916 or 717-531-1381
E-mail Address: rroden@pennstatehealth.psu.edu
Version Date:
Provide the date of this submission. This date must be updated each time the submission is provided to the IRB office 
with revisions.  DO NOT revise the version date in the footer of this document. 
12/07/22
Clinicaltrials.gov Registration #:
Provide the registration number for this study, if applicable. See “HRP-103- Investigator Manual, When do I have to 
register my project at ClinicalTrials.gov?” for more information. 
05073679
Important Instructions for Using This Protocol Template:
This template is provided to help investigators prepare a protocol that includes the necessary information needed by the 
IRB to determine whether a study meets all applicable criteria for approval.
1.
GENERAL INSTRUCTIONS:  

Prior to completing this protocol, ensure that you are using the most recent version by verifying the 
protocol template version date in the footer of this document with the current version provided in the 
CATS IRB Library.

Do not change the protocol template version date located in the footer of this document.

Some of the items may not be applicable to all types of research.  If an item is not applicable, please 
indicate as such or skip question(s) if indicated in any of the instructional text. 

GRAY INSTRUCTIONAL BOXES: 
o
Type your protocol responses below the gray instructional boxes of guidance language.  If the 
section or item is not applicable, indicate not applicable.
o
Penn State College of Medicine/Penn State Health researchers: Delete the instructional boxes 
from the final version of the protocol prior to upload to CATS IRB (http://irb.psu.edu).  
o
Penn State researchers at all other campuses: Do NOT delete the instructional boxes from the 
final version of the protocol.

Add the completed protocol template to your study in CATS IRB (http://irb.psu.edu) on the “Basic 
Information” page.  
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2.
CATS IRB LIBRARY: 

Documents referenced in this protocol template (e.g. SOP’s, Worksheets, Checklists, and Templates) can be 
accessed by clicking the Library link in CATS IRB (http://irb.psu.edu).
3.
PROTOCOL REVISIONS: 

When making revisions to this protocol as requested by the IRB, please follow the instructions outlined in 
the Study Submission Guide available in the Help Center in CATS IRB (http://irb.psu.edu) for using track 
changes. 

Update the Version Date on page 1 each time revisions are made.
If you need help…
University Park and other campuses:
Office for Research Protections Human Research 
Protection Program
The 330 Building, Suite 205
University Park, PA 16802-7014
Phone: 814-865-1775
Fax: 814-863-8699
Email: irb-orp@psu.edu
College of Medicine and Penn State Health:
Human Subjects Protection Office
90 Hope Drive, Mail Code A115, P.O. Box 855
Hershey, PA 17033
(Physical Office Location: Academic Support Building 
Room 1140)
Phone: 717-531-5687
Email: irb-hspo@psu.edu  
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Table of Contents
1.0
Objectives
2.0
Background
3.0
Inclusion and Exclusion Criteria
4.0
Recruitment Methods
5.0
Consent Process and Documentation
6.0
HIPAA Research Authorization and/or Waiver or Alteration of Authorization
7.0
Study Design and Procedures
8.0
Subject Numbers and Statistical Plan
9.0
Data and Safety Monitoring Plan
10.0
Risks
11.0
Potential Benefits to Subjects and Others
12.0
Sharing Results with Subjects
13.0
Subject Payment and/or Travel Reimbursements
14.0
Economic Burden to Subjects
15.0
Resources Available
16.0
Other Approvals
17.0
Multi-Site Study
18.0
Adverse Event Reporting
19.0
Study Monitoring, Auditing and Inspecting
20.0
Future Undetermined Research: Data and Specimen Banking
21.0
References
22.0
Confidentiality, Privacy and Data Management
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1.0
Objectives
Table 1: Objectives, Endpoints, and Justifications
Objectives
Endpoints
Justification
Primary
Primary
Primary
Evaluate the effectiveness of 
oral naltrexone tablets in 
pediatric and adolescent eating 
disorders, particularly anorexia 
nervosa and bulimia nervosa, as 
compared to placebo.
ED-15 score
ED-15 is an evidenced-based 
metric of eating disorder 
symptom severity and 
frequency.
Secondary
Secondary
Secondary
Evaluate the effect of oral 
naltrexone on desire to self-
harm and impulsivity in patients 
with eating disorders
Improvement on Eating 
Disorder Examination 
Questionnaire (EDE-Q), Patient 
Health Questionnaire-9 (PHQ-
9),  Generalized Anxiety 
Disorder-7 (GAD-7), Alexian 
Brothers Urge to Self-Injury 
Scale (ABUSI), and Behavioral 
Inhibition System/Behavioral 
Activation System score 
(BIS/BAS), need for escalation of 
level of care, desire to restart 
study article, and rate of weight 
restoration.
Naltrexone has some effect on 
desire to self-harm, and this can 
be examined in eating disorder 
patients. EDE-Q, GAD-7, PHQ- 
and BIS/BAS measure other 
features of eating disorder
Tertiary/Exploratory
Tertiary/Exploratory
Tertiary/Exploratory
none
1.1
Study Objectives
Describe the purpose, specific aims or objectives.  State the hypotheses to be tested.
The objective of this study is to evaluate the effectiveness of oral naltrexone tablets in pediatric and 
adolescent eating disorders, in particular anorexia nervosa and bulimia nervosa, as compared to 
placebo. The hypothesis of this study is that patients receiving oral naltrexone will demonstrate greater 
improvement in their score on the ED-15, an evidence-based metric of eating disorder symptom severity 
and frequency1, than those receiving placebo, representing more complete recovery from eating 
disorder
1.2
Primary Study Endpoints
State the primary endpoints to be measured in the study.  
Clinical trials typically have a primary objective or endpoint. Additional objectives and endpoints are 
secondary.  The endpoints (or outcomes), determined for each study subject, are the quantitative 
measurements required by the objectives.  Measuring the selected endpoints is the goal of a trial 
(examples: response rate and survival).
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The primary outcome will be clinically and statistically significant reduction in ED-15 score in those 
receiving medication vs placebo.
1.3
Secondary Study Endpoints
State the secondary endpoints to be measured in the study.
Secondary outcomes will include improvement in scores on Eating Disorder Examination Questionnaire 
(EDE-Q)2, the Patient Health Questionnaire-9 scale (PHQ-9,, a measure of depression)3 the Generalized 
Anxiety Disorder-7 scale(GAD-7, an inventory of anxiety)4, Alexian Brothers Urge to Self-Injure Scale 
(ABUSI; an inventory measuring the desire to self-harm)5, and Behavioral Inhibition System/Behavioral 
Activation System score (BIS/BAS; an impulsivity inventory)6; need for escalation of level of care (such as 
requirement for early termination of partial hospitalization program to attend inpatient or residential 
eating disorder care or hospitalization for medical stabilization); and rate of weight restoration. 
2.0
Background 
2.1
Scientific Background and Gaps
Describe the scientific background and gaps in current knowledge. 
For clinical research studies being conducted at Penn State Health/Penn State College of Medicine, and 
for other non-PSH locations as applicable, describe the treatment/procedure that is considered standard 
of care (i.e., indicate how patients would be treated in non-investigational setting); and if applicable, 
indicate if the treatment, drug, or device is available to patient without taking part in the study.
Oral naltrexone (Revia) is a long-acting opioid antagonist with approval from the Food and Drug 
Administration (FDA) for treatment of alcohol use disorder and provision of opioid receptor blockade7. It 
has demonstrated some utility in treating harmful, self-stimulatory behaviors (self-injurious behavior, 
SIB) in patients with autism (such as head-banging, self-mutilation, etc)8. It is generally well-tolerated, 
with few side effects outside of limiting the effectiveness of opioid medication7. Oral naltrexone became 
a therapeutic agent in the context of autism with SIB related to the “opioid hypothesis” of autism, 
namely, that the stereotyped behaviors of autism resembled those of addiction9,10. There are two 
proposed mechanisms of action for oral naltrexone in reducing self-harming behaviors: one, naltrexone 
disrupts serotonergic reward pathways that reinforce SIB11; and two, those with SIB have chronically 
elevated endogenous opioid production, where SIB increases endogenous opioid activity directly10.
There is some evidence of the value of treatment with naltrexone in bulimia12 and binge-eating disorder 
13,14, though intranasal naloxone, a related compound, has been shown to not be more efficacious than 
placebo in binge-eating disorder15. There is some evidence to suggest that naltrexone may be helpful in 
anorexia nervosa in adult patients16. A retrospective chart review of pediatric patients with bulimia did 
reveal subjective improvement in purging behaviors in patients taking oral naltrexone, however this 
study was retrospective, cross-sectional, unblinded, without a control group, and did not account for the 
effect of eating disorder therapy itself17. 
There is relatively little data regarding use of pharmacologic agents in anorexia nervosa, in particular in 
pediatric patients14,18.  The objective of this study is to evaluate the effectiveness of oral naltrexone 
tablets in pediatric and adolescent eating disorders, in particular anorexia nervosa and bulimia nervosa, 
as compared to placebo.
2.2
Previous Data
Describe any relevant preliminary data.
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The investigators for this specific study do not have any of their own preliminary data. 
2.3
Study Rationale
Provide the scientific rationale for the research.
We hypothesize that oral naltrexone will provide additional treatment benefit for adolescents and 
young adults between age 13-25 who have compulsive behavior related to eating disorder, including 
bingeing, self-induced vomiting, compulsive exercise, or other inappropriate compensatory behaviors. 
We believe this because adult literature has demonstrated some efficacy of oral naltrexone in these 
areas, and pediatric autism literature has demonstrated safety in this age group. 
3.0
Inclusion and Exclusion Criteria
Create a numbered list below in sections 3.1 and 3.2 of criteria subjects must meet to be eligible for study 
enrollment (e.g., age, gender, diagnosis, etc.). 
Vulnerable Populations:
Indicate specifically whether you will include any of the following vulnerable populations in this research. You 
MAY NOT include members of these populations as subjects in your research unless you indicate this in your 
inclusion criteria because specific regulations apply to studies that involve vulnerable populations.  
The checklists referenced below outline the determinations to be made by the IRB when reviewing research 
involving these populations. Review the checklists as these will help to inform your responses throughout the 
remainder of the protocol.

Children –Review “HRP-416- Checklist - Children”

Pregnant Women – Review “HRP-412- Checklist - Pregnant Women”

Cognitively Impaired Adults- Review “HRP-417- Checklist - Cognitively Impaired Adults” 

Prisoners- Review “HRP-415- Checklist - Prisoners”

Neonates of uncertain viability or non-viable neonates- Review “HRP-413- Checklist - Non-Viable 
Neonates” or “HRP-414- Checklist - Neonates of Uncertain Viability”
[Do not type here]
3.1
Inclusion Criteria
Create a numbered list of the inclusion criteria that define who will be included in your final study 
sample (e.g., age, gender, condition, etc.) 

Ages 13-25 (inclusive)

Any sex

Diagnoses of anorexia nervosa binge-purge subtype, bulimia nervosa, purging disorder, or 
atypical anorexia nervosa with bingeing or purging behaviors according to the Diagnostic and 
Statistical Manual version 5 diagnostic criteria

Electing to participate in child or adult partial hospitalization program for eating disorder 
treatment at MSHMC

The diagnostic criteria for anorexia nervosa, binge-purge subtype, are: 
A.
Restriction of energy intake relative to requirements, leading to a significantly low body 
weight in the context of age, sex, developmental trajectory, and physical health. 
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Significantly low weight is defined as a weight that is less than minimally normal or, for 
children and adolescents, less than minimally expected.
B.
Intense fear of gaining weight or of becoming fat, or persistent behavior that interferes with 
weight gain, even though at a significantly low weight.
C.
Disturbance in the way in which one’s body weight or shape is experienced, undue influence 
of body weight or shape on self-evaluation, or persistent lack of recognition of the 
seriousness of the current low body weight
D. During the last three months the individual has engaged in recurrent episodes of binge 
eating or purging behaviour (i.e. self-induced vomiting, or the misuse of laxatives, diuretics, 
or enemas).19
E.
A diagnosis of atypical anorexia nervosa can be made when the body weight is normal or 
high If these patients engage in bingeing or purging behaviors as defined in anorexia 
nervosa, binge-purge subtype, they are eligible for inclusion in this study

The diagnostic criteria for bulimia nervosa are:
A.
Recurrent episodes of binge eating. An episode of binge eating is characterized by
B.
both:
i.
Eating in a discrete period of time (e.g. within any 2 hour period), an amount of food 
that is definitely larger than what most individuals would eat in a similar period of 
time under similar circumstances;
ii.
A sense of lack of control over eating during the episodes (e.g. a feeling that one 
cannot stop eating or control what or how much one is eating.
C.
Recurrent inappropriate compensatory behaviors to prevent weight gain, such as self-
induced vomiting; misuse of laxatives, diuretics, or other medications; fasting; or excessive 
exercise.
D. The binge eating and inappropriate compensatory behaviors both occur, on average, at least 
once a week for 3 months.
E.
Self-evaluation is unduly influenced by body shape and weight.
F.
The disturbance does not occur exclusively during episodes of anorexia nervosa.

The diagnostic criteria for purging disorder are: recurrent purging behavior to influence weight or 
shape (e.g. self-induced vomiting; misuse of laxatives, diuretics, or other medications) in the 
absence of binge eating.
3.2
Exclusion Criteria
Create a numbered list of the exclusion criteria that define who will be excluded in your study.

Diagnosis of intellectual disability

History of known genetic or neurologic disease

Need for treatment with opioid painkillers

Weight <25kg

Inability to swallow pills

Lack of proficiency in written or spoken English

Urine drug screen positive for opioids at enrollment

Positive serum pregnancy test at enrollment 

Lactation

Elevation of three times the upper limit of normal for age in either alanine aminotransferase 
(ALT) or asparagine aminotransferase (AST).

High risk of suicide at enrollment on Columbia Suicide Severity Rating Scale (C-SSRS, for 
participants age 18)20 or Ask Suicide Screening Questions (ASQ, participants age 13 to 17)21

Current Naltrexone use 
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3.3
Early Withdrawal of Subjects
3.3.1
Criteria for removal from study
Insert subject withdrawal criteria (e.g., safety reasons, failure of subject to adhere to protocol 
requirements, subject consent withdrawal, disease progression, etc.).

New need for medical hospitalization for malnutrition or eating disorder

Need for escalation of level of care for eating disorder, that is, requirement for inpatient or 
residential-level eating disorder care

New need for opioid painkillers

Subject consent withdrawal

Inability to adhere to protocol requirements

New diagnosis of pregnancy

New elevation of three times the upper limit of normal for age in either alanine 
aminotransferase (ALT) or asparagine aminotransferase (AST).
3.3.2
Follow-up for withdrawn subjects
Describe when and how to withdraw subjects from the study; the type and timing of the data to 
be collected for withdrawal of subjects; whether and how subjects are to be replaced; the 
follow-up for subjects withdrawn from investigational treatment.

Patients who are withdrawn from the study will continue with their routine eating disorder 
care at whatever level of care is clinically appropriate for them at that time; that is, they will 
continue with routine care. Data generated from their participation in this study will be used 
to the point of their withdrawal. Specific study subjects do not require replacement.

Patients who screen positive for opioid substances at enrollment will be provided with a 
referral for substance use disorder treatment. 

Patients who screen positive for pregnancy will be referred for pregnancy options 
counseling. 
4.0
Recruitment Methods
Upload recruitment materials for your study in CATS IRB (http://irb.psu.edu).  DO NOT include the actual 
recruitment wording in this protocol.  
StudyFinder:  If StudyFinder (http://studyfinder.psu.edu) is to be used for recruitment purposes, separate 
recruitment documents do not need to be uploaded in CATS IRB. The necessary information will be captured 
from the StudyFinder page in your CATS IRB study.  
Any eligibility screening questions (verbal/phone scripts, email, etc.) used when contacting potential 
participants must be uploaded to your study in CATS IRB (http://irb.psu.edu).
[Do not type here]
4.1
Identification of subjects
Describe the source of subjects and the methods that will be used to identify potential subjects (e.g., 
organizational listservs, established recruitment databases, subject pools, medical or school records, 
interactions during a clinic visit, etc.).   If not recruiting subjects directly (e.g., database query for eligible 
records or samples) state what will be queried, how and by whom.
StudyFinder:  
o
If you intend to use StudyFinder (http://studyfinder.psu.edu) for recruitment purposes, include this 
method in this section. 
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o
Information provided in this protocol needs to be consistent with information provided on the 
StudyFinder page in your CATS IRB study.
For Penn State Health submissions using Enterprise Information Management (EIM) for recruitment, and 
for non-Hershey locations as applicable, attach your EIM Design Specification form on in CATS IRB 
(http://irb.psu.edu). See “HRP-103- Investigator Manual, What is appropriate for study recruitment?” 
for additional information. DO NOT include the actual recruitment material or wording in this protocol.
We will identify potential subjects in the Adolescent Medicine and Eating Disorders Clinic at Milton S. 
Hershey Medical Center. Potentially eligible participants are adolescents and young adults coming to 
their initial medical assessment for eating disorder evaluation. Patients who elect to attend either the 
child or adult Partial Hospitalization Program for Eating Disorders (PHP) who are also medically 
appropriate for this level of care between ages 13-25 (inclusive) will be approached at their intake 
appointment for recruitment and consent.  
4.2
Recruitment process
Describe how potential subjects first learn about this research opportunity or indicate as not applicable 
if subjects will not be prospectively recruited to participant in the research.  Subject recruitment can 
involve various methods (e.g., approaching potential subjects in person, contacting potential subjects via 
email, letters, telephone, ResearchMatch, or advertising to a general public via flyers, websites, 
StudyFinder, newspaper, television, and radio etc.). DO NOT include the actual recruitment material or 
wording in this protocol.
[Do not type here]
4.2.1
How potential subjects will be recruited.
Potential subjects will be approached at their intake appointment or at initial psychiatry 
appointment for child or adult partial hospitalization program (PHP) for eating disorder, if this is the 
level of care they have elected to pursue. The study will be explained to them at that time and consent 
will be obtained, should the potential subject wish to enroll. As all participants in the study are also 
participating in a higher level of care for eating disorder through MSHMC, all participants are patients of 
either Dr Lane or Dr Essayli, who are both study team members. 
4.2.2
Where potential subjects will be recruited.
Potential subjects will be recruited in a private therapy or medical room at the Adolescent 
Medicine and Eating Disorders Clinic on the second floor of the Briarcrest building. 
4.2.3
When potential subjects will be recruited.
Potential subjects will be enrolled at one of two times: either at the initial medical screening 
appointment after the decision has been made for the patient to enroll in PHP, or at the initial 
psychiatry appointment following  initial medical appointment (that is, at actual enrollment in 
programming).
4.2.4
Describe the eligibility screening process and indicate whether the screening process will 
occur before or after obtaining informed consent. Screening begins when the investigator 
obtains information about or from a prospective participant in order to determine their 
eligibility.  In some studies, these procedures may not take place unless HIPAA Authorization 
is obtained OR a waiver of HIPAA Authorization when applicable for the screening procedures 
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is approved by the IRB.  [For FDA regulated studies, consent for any screening activities would 
need to be obtained prior to screening unless specifically waived by the IRB.]
When patients come into the clinic for either an initial medical screening appointment for 
their enrollment in PHP or in the initial psychiatry appointment that they have when they 
enroll, a staff member will assess the patient’s eligibility in participating in the research study 
using the information in the patient’s chart and information that is obtained in the 
appointment. The primary screening criterion will be that the potential subject choses to enroll. Potential 
subjects who are not medically appropriate for PHP or who do not desire to attend PHP will not be 
screened any further for the purposes of this study. The only screening that must take place is a point-of-
care pregnancy test for postmenarchal (having had at least one menstrual cycle) females with amenorrhea 
(absent or missed menses)—which is standard of care for these patients regardless of their decision to 
enroll or not—and a urine drug screen, as oral naltrexone may cause immediate opioid withdrawal if 
administered to a person with opioid-positive urine. Potential subjects with a positive urine pregnancy test 
or urine drug screen positive for opioids will not be enrolled. Urine drug screen and urine pregnancy test 
are specifically outlined in the study consent document. 
5.0
Consent Process and Documentation 
Refer to the following materials:

The “HRP-090- SOP - Informed Consent Process for Research” outlines the process for obtaining informed 
consent.  

The “HRP-091– SOP - Written Documentation of Consent” describes how the consent process will be 
documented.

The “HRP-314- Worksheet - Criteria for Approval” section 7 lists the required elements of consent.

The “HRP-312- Worksheet - Exemption Determination” includes information on requirements for the 
consent process for exempt research.  In addition, the CATS IRB Library contains consent guidance and 
templates for exempt research.

The CATS IRB library contains various consent templates for expedited or full review research that are 
designed to include the required information.

Add the consent document(s) to your study in CATS IRB (http://irb.psu.edu). Links to Penn State’s consent 
templates are available in the same location where they are uploaded. DO NOT include the actual consent 
wording in this protocol.
[Do not type here]
5.1
Consent Process:
Check all applicable boxes below:
 Informed consent will be sought and documented with a written consent form [Complete Sections 
5.2 and 5.6] 
 Implied or verbal consent will be obtained – subjects will not sign a consent form (waiver of 
written documentation of consent) [Complete Sections 5.2, 5.3 and 5.6] 
  Informed consent will be sought but some of the elements of informed consent will be omitted or 
altered (e.g., deception). [Complete section 5.2, 5.4 and 5.6] 
 Informed consent will not be obtained – request to completely waive the informed consent 
requirement. [Complete Section 5.5]
 
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5.2
Obtaining Informed Consent 
5.2.1
Timing and Location of Consent 
Describe where and when the consent process will take place.
Consent and assent will take place at recruitment. Potential subjects will be recruited and 
enrolled at the completion of either their medical intake appointment for PHP or following the 
completion of their first psychiatry appointment on their first day of PHP. This will take place in 
a private therapy or medical room in the Adolescent Medicine and Eating Disorders Clinic, on 
the 2nd floor of the Briarcrest building. 
5.2.2
Coercion or Undue Influence during Consent 
Describe the steps that will be taken to minimize the possibility of coercion or undue influence 
in the consent process.
Prior to initiating consent for this study, medical procedures, risks and alternative therapy 
should be discussed with subjects by the medical provider, as is standard of care for partial 
hospitalization programs for eating disorders. All inclusion and exclusion criteria should be 
reviewed by the medical provider to verify that the subject meets eligibility criteria prior to 
enrollment. Consent and assent will take place in a private, neutral environment with the 
patient and their parent, if the patient is under the age of 18.  The study coordinator, not the 
principal investigator or co-investigator, will enroll the participant in the study and answer all 
questions. Potential patients under the age of 18 will be asked to provide assent to participate 
in the study; if they do not wish to provide assent then their parents cannot provide consent on 
their behalf and therefore “force” the child to participate. Potential subjects who plan to enroll 
in PHP may do so regardless of their desire to participate in this study, which will be directly 
told to them in plain, spoken language at time of consent/assent and enrollment, as well as 
written in the consent form. The decision to participate or not to participate in this study 
should have no impact on the clinical care the potential subject receives while they complete 
PHP. 
5.3
Waiver of Written Documentation of Consent 
Review “HRP – 411 – Checklist – Waiver of Written Documentation of Consent.” 
5.3.1
Indicate which of the following conditions applies to this research:
  The research presents no more that minimal risk of harm to subjects and involves no 
procedures for which written consent is normally required outside of the research context.
OR
  The only record linking the subject and the research would be the consent document and the 
principal risk would be potential harm resulting from a breach of confidentiality. Each subject 
will be asked whether the subject wants documentation linking the subject with the research, 
and the subject’s wishes will govern. (Note: This condition is not applicable for FDA-regulated 
research. If this category is chosen, include copies of a consent form and /or parental 
permission form for participants who want written documentation linking them to the 
research.)
OR
  If the subjects or legally authorized representatives are members of a distinct cultural group 
or community in which signing forms is not the norm, that the research presents no more 
than minimal risk of harm to subjects and provided there is an appropriate alternative 
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mechanism for documenting that informed consent was obtained.  (Note: This condition is not 
applicable for FDA-regulated research.) 
Describe the alternative mechanism for documenting that informed consent was obtained:
N/A
5.3.2
Indicate what materials, if any, will be used to inform potential subjects about the research 
(e.g., a letter accompanying a questionnaire, verbal script, implied consent form, or summary 
explanation of the research)
N/A
5.4
Informed consent will be sought but some of the elements of informed consent will be omitted or 
altered (e.g., deception).
Review “HRP-410-Checklist -Waiver or Alteration of Consent Process” to ensure that you have provided 
sufficient information.  
5.4.1
Indicate the elements of informed consent to be omitted or altered
N/A
5.4.2
Indicate why the research could not practicably be carried out without the omission or 
alteration of consent elements
N/A
5.4.3
Describe why the research involves no more than minimal risk to subjects.
N/A
5.4.4
Describe why the alteration/omission will not adversely affect the rights and welfare of 
subjects.
N/A
5.4.5
If the research involves using identifiable private information or identifiable biospecimens, 
describe why the research could not be practicably be carried out without using such 
information or biospecimens in an identifiable format.
N/A
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5.4.6
Debriefing 
Explain whether and how subjects will be debriefed after participation in the study. If subjects 
will not be debriefed, provide a justification for not doing so.  Add any debriefing materials to 
the study in CATS IRB.
N/A
5.5
Informed consent will not be obtained – request to completely waive the informed consent 
requirement
Review “HRP-410-Checklist -Waiver or Alteration of Consent Process” to ensure that you have provided 
sufficient information.
5.5.1
Indicate why the research could not practicably be carried out without the waiver of consent
N/A
5.5.2
Describe why the research involves no more than minimal risk to subjects.
N/A
5.5.3
Describe why the alteration/omission will not adversely affect the rights and welfare of 
subjects.
N/A
5.5.4
If the research involves using identifiable private information or identifiable biospecimens, 
describe why the research could not be practicably be carried out without using such 
information or biospecimens in an identifiable format.
N/A
5.5.5
Additional pertinent information after participation
Explain if subjects will be provided with additional pertinent information after participation. If 
not applicable, indicate “not applicable.”   
N/A
5.6
Consent – Other Considerations 
5.6.1
Non-English-Speaking Subjects
Indicate what language(s) other than English are understood by prospective subjects or 
representatives.
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If subjects who do not speak English will be enrolled, describe the process to ensure that the 
oral and written information provided to those subjects will be in that language. Indicate the 
language that will be used by those obtaining consent.
Indicate whether the consent process will be documented in writing with the long form of the 
consent documentation or with the short form of the consent documentation.  Review “HRP-
091 –SOP- Written Documentation of Consent” and “HRP-103 -Investigator Manual” to ensure 
that you have provided sufficient information. 
Because the surveys used as metrics are not validated for use in non-English-speaking patients, 
patients who do not speak or read English as a primary language will not be enrolled. 
5.6.2
Cognitively Impaired Adults
Refer “HRP-417 -CHECKLIST- Cognitively Impaired Adults” for information about research 
involving cognitively impaired adults as subjects. 
5.6.2.1 Capability of Providing Consent
Describe the process to determine whether an individual is capable of consent.
N/A
5.6.2.2
Adults Unable to Consent
Describe whether and how informed consent will be obtained from the legally 
authorized representative.  Describe who will be allowed to provide informed 
consent. Describe the process used to determine these individual’s authority to 
consent to research.
For research conducted in the state of Pennsylvania, review “HRP-013 -SOP- Legally 
Authorized Representatives, Children and Guardians” to be aware of which 
individuals in the state of Pennsylvania meet the definition of “legally authorized 
representative.”
For research conducted outside of the state of Pennsylvania, provide information 
that describes which individuals are authorized under applicable law to consent on 
behalf of a prospective subject to their participation in the procedure(s) involved in 
this research.  One method of obtaining this information is to have a legal counsel or 
authority review your protocol along with the definition of “children” in “HRP-013 -
SOP- Legally Authorized Representatives, Children, and Guardians.”
N/A
5.6.2.3 Assent of Adults Unable to Consent
Describe the process for assent of the subjects.  Indicate whether assent will be 
required of all, some or none of the subjects.  If some, indicate which subjects will 
be required to assent and which will not. 
If assent will not be obtained from some or all subjects, provide an explanation of 
why not.
Describe whether assent of the subjects will be documented and the process to 
document assent.  The IRB allows the person obtaining assent to document assent 
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on the consent document and does not routinely require assent documents and 
does not routinely require subjects to sign assent documents.
N/A
5.6.3
Subjects who are not yet adults (infants, children, teenagers) 
5.6.3.1 Parental Permission
Describe whether and how parental permission will be obtained. If permission will 
be obtained from individuals other than parents, describe who will be allowed to 
provide permission.  Describe the process used to determine these individual’s 
authority to consent to each child’s general medical care.
For research conducted in the state of Pennsylvania, review “HRP-013-SOP- Legally 
Authorized Representatives, Children and Guardians” to be aware of which 
individuals in the state of Pennsylvania meet the definition of “children.” 
For research conducted outside of the state of Pennsylvania, provide information 
that describes which persons have not attained the legal age for consent to 
treatments or procedures involved in the research, under the applicable law of the 
jurisdiction in which research will be conducted.  One method of obtaining this 
information is to have a legal counsel or authority review your protocol along with 
the definition of “children” in “HRP-013-SOP- Legally Authorized Representatives, 
Children, and Guardians.”
Parental permission and assent will be sought at the same time from minor 
participants and their parents. The minor will be asked to sign, indicating their 
assent to participate in this project, as well as their parent will be asked to 
provide consent. If either party does not wish to sign or does not wish to 
participate in this study, they will not be enrolled and they will receive standard 
care in PHP. 
5.6.3.2 Assent of subjects who are not yet adults
Indicate whether assent will be obtained from all, some, or none of the children. If 
assent will be obtained from some children, indicate which children will be required 
to assent. When assent of children is obtained describe whether and how it will be 
documented.
All potential participants between 13 and 18 years of age will be asked to provide 
written assent at time of recruitment into the study, as discussed above. As 
discussed above, if the child does not (or cannot) provide written assent they will 
not be recruited, regardless of the parents’ desire vis-à-vis this study. Potential 
participants and their parent(s) will be asked to provide written consent and assent 
at the same time, as above, and the consent form also includes a specific portion for 
written assent. 
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6.0
HIPAA Research Authorization and/or Waiver or Alteration of Authorization
This section is about the access, use or disclosure of Protected Health Information (PHI). PHI is individually 
identifiable health information (i.e., health information containing one or more 18 identifiers) that is transmitted 
or maintained in any form or medium by a Covered Entity or its Business Associate. A Covered Entity is a health 
plan, a health care clearinghouse or health care provider who transmits health information in electronic form.  
See “HRP-103 -Investigator Manual” for a list of the 18 identifiers.  
If requesting a waiver/alteration of HIPAA authorization, complete sections 6.2 and 6.3 in addition to section 
6.1. The Privacy Rule permits waivers (or alterations) of authorization if the research meets certain conditions. 
Include only information that will be accessed with the waiver/alteration. 
[Do not type here]
6.1
Authorization and/or Waiver or Alteration of Authorization for the Uses and Disclosures of PHI
Check all that apply:
 
Not applicable, no identifiable protected health information (PHI) is accessed, used or 
disclosed in this study. [Mark all parts of sections 6.2 and 6.3 as not applicable]
Authorization will be obtained and documented as part of the consent process. [If this is the 
only box checked, mark sections 6.2 and 6.3 as not applicable]
Partial waiver is requested for recruitment purposes only (Check this box if patients’ medical 
records will be accessed to determine eligibility before consent/authorization has been 
obtained). [Complete all parts of sections 6.2 and 6.3]
Full waiver is requested for entire research study (e.g., medical record review studies). 
[Complete all parts of sections 6.2 and 6.3]
Alteration is requested to waive requirement for written documentation of authorization 
(verbal authorization will be obtained). [Complete all parts of sections 6.2 and 6.3]
6.2
Waiver or Alteration of Authorization for the Uses and Disclosures of PHI
6.2.1
Access, use or disclosure of PHI representing no more than a minimal risk to the privacy of the 
individual
6.2.1.1
Plan to protect PHI from improper use or disclosure
Include the following statement as written – DO NOT ALTER OR DELETE 
unless this section is not applicable because the research does not involve a 
waiver of authorization. If the section is not applicable, remove the 
statement and indicate as not applicable. 
Information is included in the “Confidentiality, Privacy and Data 
Management” section of this protocol.
6.2.1.2
Plan to destroy identifiers or a justification for retaining identifiers 
Describe the plan to destroy the identifiers at the earliest opportunity 
consistent with the conduct of the research. Include when and how 
identifiers will be destroyed. If identifiers will be retained, provide the legal, 
health or research justification for retaining the identifiers.
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All data will be maintained in RedCAP, and will be accessible only to study 
members. A key linking study participants to study data will be kept for the 
duration that the study data are kept, and all research data will be retained 
per FDA regulation and institutional policy. Data maintained in PennState 
Health drives will be destroyed in accordance with current data management 
protocols at our institution and paper records will be securely shredded and 
incinerated. 
6.2.2
Explanation for why the research could not practicably be conducted without access to and 
use of PHI
Provide an explanation for why the research could not practicably be conducted without access 
to and use of PHI.
Much of the outcomes to be studied here, including weight restoration, length of time in care, 
or worsening of depression, are assessed on a regular basis as a part of routine clinical care. 
Because participants in this study will otherwise be undergoing routine care in PHP, access to 
PHI would reduce need for duplicate visits for study purposes only and should increase study 
retention. Additionally, certain inclusion and exclusion criteria, such as lab results, will be 
available in PHI and help determine participant eligibility.
6.2.3
Explanation for why the research could not practicably be conducted without the waiver or 
alteration of authorization
Provide an explanation for why the research could not practicably be conducted without the 
waiver or alternation of authorization.
Because participation in this study requires negative urine drug screen and normal bloodwork 
prior to enrollment, without being able to evaluate PHI prior to enrollment we will not be able 
to determine who is eligible without duplicating studies and potentially exposing the patient to 
excessive risk and pain in the form of duplicate lab studies and blood draws. 
6.3
Waiver or alteration of authorization statements of agreement
By submitting this study for review with a waiver of authorization, you agree to the following statement – 
DO NOT ALTER OR DELETE unless this section is not applicable because the research does not involve a 
waiver or alteration of authorization. If the section is not applicable, remove the statement and indicate 
as not applicable.
Protected health information obtained as part of this research will not be reused or disclosed to any 
other person or entity, except as required by law, for authorized oversight of the research study, or for 
other permitted uses and disclosures according to federal regulations. 
The research team will collect only information essential to the study and in accord with the ‘Minimum 
Necessary’ standard (information reasonably necessary to accomplish the objectives of the research) per 
federal regulations. 
Access to the information will be limited, to the greatest extent possible, within the research team. All 
disclosures or releases of identifiable information granted under this waiver will be accounted for and 
documented.
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7.0
Study Design and Procedures
Data collection materials that will be seen or used by subjects in your study must be uploaded to CATS IRB 
(http://irb.psu.edu).   DO NOT include any actual data collection materials in this protocol (e.g., actual survey or 
interview questions)
[Do not type here]
7.1
Study Design
Describe and explain the study design.
This is a double-blind, randomized, placebo-controlled study. We have developed the following schedule 
of events. All events with a superscript o are for study purposes only and are not part of the standard of 
care: 
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Intervention
Pre-Enrollment 
Screening: 
Medical
Enrollment
Week 1
Week 2
Week 3
Week 4
Week 5
Week 6 (end of 
treatment
Week 8-9 (post-
treatment)
Six Months
Initial Medical Assessment
x
Subsequent Medical 
Assessment, including 
comprehensive review of 
systems
x
x
x
x
x
Initial Psychiatry Assessment
x
Subsequent Psychiatric 
Assessment, including suicidal 
ideation
x
x
x
x
x
x
x
x
Discussion of risks and benefits, 
inclusion and exclusion criteriao
x
Consent/Assento
x
$25 Greenphire Clincardo
x
x
Urine Drug Screeno
x
Serum Pregnancy Test (female 
participants)o
x
Urine Pregnancy Test (female 
participants)o
x
x
Administer Study Articleo
x
x
x
x
x
x
EKG
x
AST
x
xo
xo
ALT
x
xo
xo
Total Bilirubin
x
xo
xo
Direct bilirubin
x
xo
xo
Heart Rate
x
x
x
x
x
x
x
x
x
BMI
x
x
x
x
x
x
x
x
x
Height
x
x
x
x
x
x
x
x
x
Weight
x
x
x
x
x
x
x
x
x
Blood Pressure
x
x
x
x
x
x
x
x
x
Temperature
x
x
x
x
x
x
x
x
x
Adverse event monitoringo
x
x
x
x
x
x
x
x
Suicidal Ideation Screening (ASQ 
for age <17or C-SSRS for age 
18+)
x
x
x
x
x
x
x
x
x
ED-15
x
x
x
x
X
x
EDE-Q
x
x
x
x
X
x
ABUSIo
x
x
x
x
X
x
GAD-7
x
x
x
x
X
x
PHQ-9
x
x
x
x
X
x
BIS/BASo
x
x
x
x
x
x
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Note: Medical assessments may occur in weeks 1,3 etc or 2,4 etc depending on standard of care for that 
patient. As long as patients are seen within a 14 day interval (2 week timeframe), the exact week 
intervals (1,3 or 2,4) may vary. Additionally, the 6 month follow up appointment may take place any 
time between 5-7 months after study enrollment ends. 
7.2 
Study Procedures
Provide a step by step description of all research procedures being conducted (broken down by visit, if 
applicable) including such information as below (where and when applicable); describe the following:

HOW: (e.g., data collection via interviews, focus groups, forms such as surveys and questionnaires, 
medical/school records, audio/video/digital recordings, photographs, EKG procedures, MRI, mobile 
devices such as electronic tablets/cell phones, observations, collection of specimens, experimental 
drug/device testing, manipulation of behavior/use of deception, computer games, etc.)

WHERE: (e.g., classrooms, labs, internet/online, places of business, medical settings, public spaces, 
etc.)
Subjects participating in this study will receive routine care for eating disorder at a partial hospitalization 
(PHP) level of care at MSHMC. In PHP, all patients have biweekly medical screening visits for the 
duration of their time in care, as well as weekly individual therapy sessions, individual dietician sessions, 
and psychiatry appointments. They have supervised meals and numerous group therapy sessions. Every 
three weeks, patients in PHP complete a battery of mood and eating disorder indices including those 
evaluated in this study; participants in this study will complete an additional two surveys with this 
routine battery. Participants in this study will have no alterations in their routine eating disorder care 
outside of study article use and these additional surveys. 
Subjects will be enrolled at their first visit for eating disorder programming at child or adult partial 
hospitalization (PHP) programming at MSHMC adolescent medicine eating disorders clinic. Informed 
consent/assent will be obtained as described above.
The subject will be provided with oral naltrexone or placebo weekly from the MSHMC research 
pharmacy. Subjects will be given one weeks’ worth of medication at a time.  Subjects will be randomized 
at enrollment to receive either study drug (naltrexone) or placebo. Participants or parents of minor 
participants will be provided study drug or placebo following completion of urine drug screen and 
consent/assent. Patients will take the medication daily while they are in programming; after completion 
of programming or withdrawal from the study they will no longer be given study medication. For 
subjects who are enrolled in child PHP and who eat meals with parents, the families may choose to 
administer study drug during meals at programming. For adult patients enrolled in adult programming, 
subjects may choose to self-administer the medication.
On their first contact with PHP, all patients in Adult PHP complete various eating disorder indices as a 
part of routine care, including the ED-15, PHQ-9, GAD-7, and EDE-Q. This battery of indices is repeated 
every 3 weeks while a patient is in programming. 
For those who are enrolled in this study, they will complete their routine indices, in addition they will 
also complete the BIS/BAS and the ABUSI at enrollment and at weeks 1, 3, and 6 while enrolled in the 
study. Participants will also be asked to take the routine indices (ED-15, EDE-Q, PHQ, GAD, BIS/BAS, and 
ABUSI) at week 8 or 9 for a post-treatment evaluation. These will be taken in an in-person medical 
appointment or electronically via RedCap
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6 months after enrollment, subjects will be sent copies of ED-15, EDE-Q, PHQ, GAD, BIS/BAS, and ABUSI 
indices either in an in-person medical appointment or via RedCap to complete. If the patient returns for 
medical follow-up between 5 and 7 months after enrollment, their height, weight, and body mass index 
will also be recorded to determine if weight restoration was maintained.
Patients in Child PHP typically complete a different inventory every three weeks as part of routine care. 
If a patient choses to participate in this study they will be asked to complete the same surveys as 
participants in Adult PHP (ED-15, GAD-7, and PHQ-9), and they will receive the same amount and type of 
compensation as those who already take them as part of standard of care. 
REDCap, will be used to store the surveys. Participants will be sent the link to the battery of surveys via 
email at the designated times listed above. The link will redirect them to the programmed surveys in 
REDCap. Their responses will be stored in REDCap until data is exported and stored on the secure file 
server (hersheymed.net/files). Only authorized study personnel will have access to the REDCap surveys 
and folder access on the secure network. 
At initial contact with the eating disorders clinic, all patients receive an initial battery of laboratory tests 
as a part of the standard of care for eating disorder. These tests include liver function assays and 
transaminase levels. Further information about liver function test and monitoring for drug-induced liver 
injury is outlined in section 9.0. 
7.1.1
Enrollment. 
Provide a description of what procedures will be performed on visit 1 or day 1 or pre-test in 
order of how these will be done.  If your study only involves one session or visit, use this section 
only and indicate 7.2.2 as not applicable. 
As discussed above, patients can be enrolled at either their initial medical or initial psychiatric 
appointments for participation in the appropriate PHP for eating disorder.Per Joint Commission 
regulations of partial hospitalization programs for any psychiatric diagnosis, a complete blood count, 
blood chemistry, liver function test, urinalysis, and electrocardiogram must be obtained at enrollment 
and other studies at the program’s discretion. If all necessary bloodwork, EKG, and urine studies have 
been obtained within the last two weeks, these results will be tracked down, recorded into the medical 
record, and any necessary and routine studies that have not been completed prior to this appointment 
will be completed at enrollment. 
For patients enrolling at their medical appointment: after completion of the medical appointment, the 
study coordinator will approach the patient and family (if the patient is under 18 years of age), and 
discuss the study. The study coordinator will review the consent/assent forms, and after completion of 
the appointment the patient will be asked to obtain their routine studies (unless they have already been 
obtained as described above) within the coming seven days. A urine drug screen will be obtained at no 
cost to the participant and its results will not be placed into the medical record. Patients screening 
positive for any opioid will be excluded from the study and offered referral for addiction counseling. For 
potential female subjects, a serum pregnancy test will also be obtained at this time. Patients screening 
positive for pregnancy will be referred for options counseling
For patients enrolling at their psychiatric appointment: Joint Commission regulations regarding 
obtaining lab studies are unchanged, regardless of initial appointment location. All patients in PHP have 
biweekly medical appointments as a part of routine care, and routine enrollment labs are typically 
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obtained at the first medical appointment after first psychiatric appointment during the first seven days 
of programming. Labs will be ordered at that appointment and obtained within seven days, or entered 
into the medical record if obtained elsewhere, at that time. A urine drug screen will be obtained at no 
cost to the participant and its results will not be placed into the medical record. Patients screening 
positive for any opioid will be excluded from the study and offered referral for addiction counseling. For 
potential subjects who are female, a serum pregnancy test will also be obtained at this time. Patients 
with a positive pregnancy test will be referred for options counseling.
All participants, regardless of sex assigned at birth, gender, or menarchal status, will be required to use a 
highly reliable form of contraception should they be sexually active. Acceptable options have failure 
rates of less than 1% and include: combined hormonal contraceptives (such as oral contraceptive pills, 
patch, or vaginal ring), intrauterine device, depot-medroxyprogesterone injection, etonogesterel-
containing implants, and progestin-only contraceptive pills. Condoms, either internal or external, are not 
sufficient contraception if used alone. If a participant with a birth-assigned sex of female discloses coitus 
while participating in the study either without the use of contraception or with contraceptive failure 
(such as a broken condom with no second method of contraception), the participant will be offered a 
prescription for emergency contraceptive (ulipristal acetate or levonorgesterel 1.5mg) within 72 hours 
after coitus, pregnancy testing 14 days after the episode of coitus with referral according to results, and 
will be withdrawn from the study. 
7.1.2
Visit 2 or Day 2 or Post-test, etc. (If applicable) 
Provide a description of what procedures will be performed on visit 2 or day 2 or post-test in 
order of how these will be done.  If your study involves more than two sessions or visits 
replicate this section for each additional session or visit (e.g., 7.2.3, 7.2.4, etc.). 
On the first day of study participation after enrollment, all subjects will receive a complete set of 
vital signs (including heart rate, blood pressure, respiratory rate, temperature, and weight) and 
urine drug screen including screening for opioid substances prior to receipt of their first dose of 
study article. 
Routine care during PHP for any participant includes every-other-week in-person medical exams 
for the duration of the patient’s stay in program, as well as frequent appointments following 
completion of PHP, until discharge from clinic. At each medical appointment, patients receive a 
comprehensive physical exam including complete vital signs as above, and are routinely asked 
about mood changes, physical changes, difficulty or ease of adhering to routine program 
protocols, etc. All patients participating in PHP complete routine surveys to assess eating 
disorder recovery at intake and every three weeks until completion of program. For participants 
in this study, the documentation of their three- and six-week appointments will be reviewed for 
evidence of adverse effects related to study participation by study personnel. Participants will 
also complete two additional surveys, the ABUSI and BIS/BAS, beyond their routine PHP surveys 
at weeks three, six, and eight/nine. Routine medical testing will be obtained according to clinical 
need at all medical visits, regardless of participation in this study, for all patients participating in 
PHP.
For patients participating in this study, liver function panel will be obtained once every 3 weeks 
at no cost to study participants for the purpose of monitoring drug safety, as well as completion 
of all of the relevant study indices 
The vast majority of patients who require PHP have a routine medical follow-up at 
approximately six months; for those who do not this appointment will be made at no cost to the 
participant. At this appointment, participants will again undergo a comprehensive physical 
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exam, receive a complete set of vital signs, be interviewed on eating disorder symptomatology, 
and be asked to fill out study indices again and will be given a $25 Greenphire Clincard card for 
their time. 
7.2
Duration of Participation
Describe how long subjects will be involved in this research study.  Include the number of sessions and 
the duration of each session - consider the total number of minutes, hours, days, months, years, etc.  
Subjects will be enrolled in this study for a total of six months, starting at enrollment in PHP, and 
continuing to their final 6-month follow-up visit. They will have study interventions at 0, 3, and 6 weeks, 
and again at six months. They will take study medication while in PHP, and stop once six weeks of study 
duration is completed. Duration of PHP is individualized, but is on average about 8 weeks. Duration of 
PHP will not be dependent upon study participation. 
7.3
Test Article(s) (Study Drug(s) and/or Study Device(s))
7.3.1
Description
Provide a brief description of all test articles (drugs (including any foods and dietary 
supplements), devices and/or biologics used in the research including the purpose of their use 
and their approval status with the Food and Drug Administration (FDA). Include information 
about the form of the drug product (e.g., tablets, capsules, liquid).
The Penn State Health IDS pharmacy will purchase Naltrexone 50mg tablets from a 
pharmaceutical wholesaler.  The IDS pharmacy will purchase gelatin capsules and USP grade 
methylcellulose from a pharmacy supplier to be used for compounding the active and placebo 
capsules.  For the active Naltrexone 50mg capsules, a Naltrexone 50mg tablet will be placed in 
an empty gelatin capsule with methylcellulose filler.  The placebo capsules will be empty gelatin 
capsules filled with Methylcellulose. 
The Food and Drug Administration has approved oral naltrexone for the treatment of alcohol 
use disorder and for blockade of opioid receptors7. This medication is not approved for the 
specific use of treatment of eating disorder, impulsive behavior, or self-injurious behavior. 
7.3.2
Treatment Regimen
Describe dose, route of administration and treatment duration. Include information about dose 
adjustments.
All subjects receiving study medication will receive oral naltrexone 50mg oral tablets, blinded as 
described above. All subjects receiving placebo will receive methylcellulose, blinded as 
described above. All capsules, regardless of contents, will be administered by mouth once daily, 
at a time of day to be chosen by the study participant.
In pediatric autism literature, doses between 0.5-2 mg/kg are described8,11,22,22–25, though in 
adult eating disorder literature doses of 50-100mg are described13,14,16–18. Food and Drug 
Administration labelling of oral naltrexone for treatment of alcohol use disorder and opioid 
receptor blockade describe an appropriate maintenance dose of 50mg per day7. Therefore 
subjects will receive 50mg of oral naltrexone a day if they are randomized to the medication 
group. Patients with body weight less than 25kg are excluded from the study so that no 
participant will exceed the maximum described pediatric dose of 2 mg/kg. Participants receiving 
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study article will receive 25mg of naltrexone for three days, followed by increase to study dose 
of 50mg/day The maximum daily dose is 50mg. 
Participants will take study medication daily while they are in PHP or for six weeks total. That is, 
if a participant is in PHP for three weeks, they will take the study medication for the entirety of 
their time in PHP and then continue to take the medication for three additional weeks after 
discharge from PHP. If a participant is in PHP for twelve weeks—which is quite uncommon—
they will only take study medication for six weeks. 
For participants who complete PHP early, they will be asked to complete the same battery of 
surveys at 3 and 6 weeks, at weeks 8/9 for post-treatment evaluation, and at 6 months. Survey 
responses will be obtained via RedCAP for participants not on-site at time of survey completion. 
Participants who, upon completion of the study, feel that they had significant benefit from the 
study article which lost upon withdrawal of the study article, are eligible for open label oral 
naltrexone therapy if desired. Participants will be asked at subsequent medical and behavioral 
health follow-up appointments if they felt they benefitted from the study article. If they feel 
they did, they will be offered a prescription for oral naltrexone to start at 25mg/day for three 
days and then 50mg a day after. 
7.3.3
Method for Assigning Subject to Treatment Groups
Describe the randomization process and how the associated treatment assignment will be 
made.
Subjects will be randomized at enrollment using RedCap. Randomization will be stratified by age 
(16 and under or 17 and older) and diagnosis (anorexia nervosa binge/purge subtype and 
bulimia nervosa or OSFED with bingeing or purging behaviors), equaling 4 strata.
7.3.4
Subject Compliance Monitoring
Insert the procedures for monitoring subject compliance.
Participants will receive one week of study intervention at a time, provided by Penn State 
Research Pharmacy. Medication will be delivered weekly to the Milton S. Hershey Medical 
Center Adolescent Medicine and Eating Disorders Clinic. At the time of delivery of a new week’s 
supply of medication, participants will return any unused medication for pill counts to 
determine adherence.
Additionally, participants in PHP are allowed to either self-administer medication or receive 
medication from their parents, if under 18 years of age. Participants will have the option to take 
medication on-site during programming, either as self-administration if over 18 years of age or 
from a parent if 17 years of age or younger, as they will be in clinic for about 8 hours a day, from 
their own supply. No study or clinic staff will handle medication. No study or clinic staff will 
administer medication. 
7.3.5
Blinding of the Test Article
Describe how the test article is blinded.
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The Penn State Health IDS pharmacy will purchase Naltrexone 50mg tablets from a 
pharmaceutical wholesaler.  The IDS pharmacy will purchase gelatin capsules and USP grade 
methylcellulose from a pharmacy supplier to be used for compounding the active and placebo 
capsules.  For the active Naltrexone 50mg capsules, a Naltrexone 50mg tablet will be placed in 
an empty gelatin capsule with methylcellulose filler.  The placebo capsules will be empty gelatin 
capsules filled with Methylcellulose.
7.3.6
Receiving, Storage, Dispensing and Return 
7.3.6.1
Receipt of Test Article 
Describe how the test article will be obtained and from what source. 
Describe how the study test article will be packaged along with amounts 
(e.g., number of tablets/capsules or volume of liquid) and labeling. If drug 
kits are used, describe all the contents of the kit and associated labeling.
The Penn State Health IDS pharmacy will purchase Naltrexone 50mg tablets 
from a pharmaceutical wholesaler.  The IDS pharmacy will purchase gelatin 
capsules and USP grade methylcellulose from a pharmacy supplier to be used 
for compounding the active and placebo capsules.  For the active Naltrexone 
50mg capsules, a Naltrexone 50mg tablet will be placed in an empty gelatin 
capsule with methylcellulose filler.  The placebo capsules will be empty gelatin 
capsules filled with Methylcellulose.
Participants will receive seven gelatin capsules at a time, packaged in 
conventional amber plastic medication bottles with child safety caps. These will 
be brought to the Milton S. Hershey Medical Center Adolescent Medicine and 
Eating Disorders Clinic weekly by Penn State Research Pharmacy staff and given 
to participants in that setting. At time of receipt of one week’s worth of study 
medication, any remaining medication from the previous week will be returned 
to the research pharmacy and disposed of by pharmacy staff according to 
guidelines. 
7.3.6.2
Storage
Describe the plans to store, handle the test article so they will be used only 
on subjects and only by authorized investigators. Describe storage 
temperature requirements and how temperature will be monitored and 
recorded.
As described above, test article will be dispensed to participants or 
participants’ parents/legal guardians in the MSHMC Adolescent Medicine 
and Eating Disorders Clinic. All participants in this study are also patients in 
PHP, therefore they all have patient identification bands while they are on-
side. Participant identity will be verified with ID bands, and their legal 
guardians will be identified by government-issued photo identification. 
Participants can self-administer test-article on site during PHP, or 
participants’ parents can administer the test article on site. While this is 
clearly optional and not feasible for all participants on all days—especially 
weekends—this method will be encouraged by study staff, though study 
and clinic staff will neither handle nor administer study medication. 
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Oral naltrexone tablets are stable at room temperature, between 20-25 
degrees centigrade7. No specific temperature monitoring is necessary. 
7.3.6.3
Preparation and Dispensing
Describe how the test article will be assigned to each subject and 
dispensed. Describe the steps necessary to prepare the test article. Include 
where the test article preparation will be done and by whom. Fully 
describe how the study treatment is to be administered and by whom.
Subjects will be randomly assigned to study article or to placebo as 
described above. The IDS pharmacy will purchase gelatin capsules and USP 
grade methylcellulose from a pharmacy supplier to be used for 
compounding the active and placebo capsules.  For the active Naltrexone 
50mg capsules, a Naltrexone 50mg tablet will be placed in an empty gelatin 
capsule with methylcellulose filler.  The placebo capsules will be empty 
gelatin capsules filled with Methylcellulose.
The study article or placebo will be self-administered as an oral medication. 
7.3.6.4
Return or Destruction of the Test Article
Describe the procedures for final reconciliation of the test article supply at 
the end of the study and whether the test article is to be shipped back to a 
source or destroyed on site.
Expired medications and medications returned by subjects unused will be 
documented and destroyed as per the IDS Destruction Policy.   At the end 
of the study, any remaining study medications will be documented and 
destroyed as per the IDS Destruction Policy.
7.3.6.5
Prior and Concomitant Therapy
Describe what prior and/or concomitant medical therapy will be collected. 
Describe which concomitant medicines/therapies are permitted during the 
study. Describe which concomitant medicines are not permitted during the 
study.
Many patients in PHP are on other medications, some of which are 
relevant to psychiatric diagnoses—such as selective serotonin reuptake 
inhibitors—and several are not, such as polyethylene glycol for 
constipation. Medication usage will be tracked during this study by 
following medication reconciliation performed at biweekly medical 
appointments while in PHP, which is the standard of care for patients 
requiring this level of care. 
Participants will be permitted any medication other than opioid 
medications. Any potential participant with a prescription for opioid 
medication, such as buprenorphine/naloxone combination strips or with a 
positive urine drug screen for opioids will be excluded. Any participant 
requiring opioid painkillers during this study will be dropped from the 
protocol. Patients will not be permitted to use medical cannabis during this 
study. 
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8.0
Subject Numbers and Statistical Plan
8.1
Number of Subjects
Indicate the maximum number of subjects to be accrued/enrolled. Distinguish between the number of 
subjects who are expected to be enrolled and screened, and the number of subjects needed to 
complete the research procedures if applicable (i.e., numbers of subjects excluding screen failures.)
Because this is a pilot study, we have decided a priori to enroll 30 participants in each arm of treatment 
for a total of sixty subjects. In 2019, approximately 150 patients meeting criteria for potential inclusion 
(between ages of 12-18, needing PHP level of care in the eating disorder clinic, no diagnosis of gender 
dysphoria or intellectual disability, with diagnoses of anorexia nervosa, or bulimia nervosa) were seen 
for initial evaluation in the eating disorder clinic. Therefore we hope to be able to enroll sixty 
participants over the course of 12 to 18 months. 
8.2
Sample size determination
If applicable, provide a justification of the sample size outlined in section 8.1 to include reflections on, or 
calculations of, the power of the study.
This is a pilot study, and enrollment size was determined a priori to allow for completion of enrollment 
within 18 months. 
8.3
Statistical methods
Describe the statistical methods (or non-statistical methods of analysis) that will be employed.
 
For analysis, data will be analyzed for differences between participants receiving naltrexone and 
participants receiving placebo. The data will be analyzed for demography differences between the two 
groups at baseline, and outcomes will be compared at three and six weeks; as well as at 6 months. 
Outcomes to be compared are stated in section 1.1 and 1.2. Within each group, these outcomes will also 
be compared across time. Statistically significant differences between each group at each endpoint will 
be noted and reported. 
9.0
Data and Safety Monitoring Plan
This section is required when research involves more than Minimal Risk to subjects as defined in “HRP-001 
SOP- Definitions.”
Minimal Risk is defined as the probability and magnitude of harm or discomfort anticipated in the research that 
are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of 
routine physical or psychological examinations or tests.  For research involving prisoners, Minimal Risk is the 
probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in 
the routine medical, dental, or psychological examination of healthy persons. 
Please complete the sections below if the research involves more than minimal risk to subjects, otherwise 
indicate each section as not applicable. 
[Do not type here]
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9.1
Periodic evaluation of data
Describe the plan to periodically evaluate the data collected regarding both harms and benefits to 
determine whether subjects remain safe.
This clinical trial will be monitored with the assistance of the Data Management Unit at Penn State 
Health College of Medicine. Once weekly, the principal investigator and members of the study team will 
review results of liver function screens, pregnancy tests, vital signs, and results of the Columbia Suicide 
Severity Rating Scale (C-SSRS, for participants age 18 and older ) or Ask Suicide Screening Questions 
(ASQ, for patients age 13 to 17)for all participants. Results of liver function tests, pregnancy tests, and 
vital signs will be recorded and tracked using a secured database.
It is expected that the total blood draw volume for this study will not exceed 16ml (for male 
participants) and 18ml (for female participants), using a volume of 4ml for measurement of hepatic 
function three times over nine weeks, and 1.5ml for serum pregnancy testing, with allowance for error 
in draw.
9.2
Data that are reviewed
Describe the data that are reviewed, including safety data, untoward events, and efficacy data.
Participants in this study will take the study article daily while they are enrolled in program. When they 
complete program, they will no longer be obliged to take the study article, nor will they be required to 
have weekly psychiatric evaluation, laboratory evaluation, or suicide assessments.  Patients in PHP have 
at least one medical follow-up appointment two weeks after they complete program, and further 
follow-up based on the patient’s needs.
During the course of the trial, we will monitor:

New diagnoses of depression, anxiety, suicidal thoughts, suicidal ideation, self-injurious 
behavior and related diagnoses via chart review. Monitoring for these new diagnoses is a part of 
routine care of PHP

The results of every-three-weeks liver function tests

The results of every-three-weeks urine pregnancy tests in female participants

Vital signs

The results of the behavioral health surveys

New diagnoses of abdominal pain, nausea, vomiting, headache, or fatigue regardless of 
relationship to diagnosis of eating disorder, though these are common problems in eating 
disorder treatment

New diagnoses of jaundice, liver failure, elevated transaminases, rash, or other medical 
problems that are uncommon in the treatment of eating disorder. 

New diagnosis of pregnancy

Length of participation in PHP, as patients who are experiencing good results with the study 
article may require a shortened length of stay in program

Need for escalation of eating disorder or mental health care, such as need for inpatient 
hospitalization for medical stabilization of eating disorder or other medical diagnosis, need for 
residential care for eating disorder, 

Incidence of death or serious bodily harm

Incidence of acute withdrawal from narcotic agents (expected to be zero due to pre-
participation urine drug screen, though this is a serious event)
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9.3
Method of collection of safety information
Describe the method by which the safety information will be collected (e.g., with case report forms, at 
study visits, by telephone calls and with subjects).
 All patients participating in PHP receive biweekly medical visits, including comprehensive physical exam, 
vital signs, review of suicidal thoughts or behaviors, review of systems, and review of eating disorder 
symptom severity and frequency as a part of routine care in PHP. Patients also fill out the Columbia 
Suicide Severity Rating Scale (C-SSRS a metric assessing for the presence and severity of suicidality) or 
Ask Suicide Screening Questions (ASQ, a similar metric) once weekly while in care, with patients age 18 
and older using the C-SSRS and patients age 13-17 using the ASQ. Participants in this study will be no 
different, with the notable exception of every-three-week liver function and urine pregnancy tests 
(assigned female at birth patients only). 
Study participants’ charts will be reviewed weekly while they are in program by the PI and the study 
coordinator for any of the above-mentioned possible new diagnoses, lab results, C-SSRS results, as well 
as review of all routine care detailed above. Study staff who provide direct care to participants will alert 
the PI and the study coordinator of any adverse events encountered during the course of routine care. 
The results of all safety screenings will be kept in a comprehensive, secure database and will be 
reviewed weekly by the study team
9.4
Frequency of data collection
Describe the frequency of data collection, including when safety data collection starts.
Safety data collection will begin at enrollment, as vital signs, serum pregnancy tests, and urine drug 
screens will be collected at that time, continue through the first medical appointment after enrollment 
in the study, and will be subsequently obtained at weekly intervals thereafter.
9.5
Individuals reviewing the data
Identify the individuals who will review the data. The plan might include establishing a data and safety 
monitoring committee and a plan for reporting data monitoring committee findings to the IRB and the 
sponsor.
The PI and study coordinator will review the safety data at weekly intervals with the assistance of the 
Data Management Unit at Penn State College of Medicine. Any adverse events deemed to be the result 
of study participation and not the result of routine eating disorder care will be reported to the IRB as 
well as the study sponsor. 
9.6
Frequency of review of cumulative data
Describe the frequency or periodicity of review of cumulative data.
 The PI and study coordinator will review the safety data at weekly intervals with the assistance of the 
Data Management Unit at Penn State College of Medicine. Any adverse events deemed to be the result 
of study participation and not the result of routine eating disorder care will be reported to the IRB as 
well as the study sponsor.
9.7
Statistical tests
Describe the statistical tests for analyzing the safety data to determine whether harms are occurring.
No statistical tests for analyzing safety data are scheduled for this trial. 
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9.8
Suspension of research
Describe any conditions that trigger an immediate suspension of research.
  Monitoring for safety of the study article will be completed in accordance with Federal Food and Drug 
Administration requirements for surveillance of drug-induced liver injury (DILI), in accordance with Hy’s 
law. 
The study will be stopped early in the event of certain specific conditions that are more likely to be due 
to study intervention than to the disease itself. Several possible adverse effects of this medication can 
also be common features of eating disorder or eating disorder treatment itself, including worsening 
depression, self-injurious behavior, and suicide attempt 7,10,11,17,26–29. The following circumstances would 
trigger immediate suspension of this study with evaluation of safety data and profile:

Death of a study participant

Psychiatric hospitalization for suicidal ideation in any two study participants within a six month 
window

Two participants experiencing elevation of AST or ALT more than three times the upper limit of 
normal for age during the course of the study. 

AST or ALT levels elevated more than five times the upper limit of normal in any participant at 
any time. 

One participant with elevated serum total bilirubin to more than twice the upper limit of normal 
for age with evidence of pure hepatocellular injury (that is, no evidence of obstruction, 
malignancy, genetic disease, other medication effects, viral or bacterial infection) and AST or 
ALT elevation greater than three times the upper limit of normal for age. 

New diagnosis of liver failure of any participant

Any other serious medical or psychiatric condition felt to be potentially related to the study 
article. 
Any suspected case of drug-induced liver injury will be reported to the Food and Drug 
Administration using the specified information provided in the FDA’s document, Guidance for Industry 
Drug-Induced Liver Injury: Premarketing Clinical Evaluation. 
Should any participant demonstrate elevation of AST/ALT above the upper limit of normal for 
age, the study article will be discontinued. AST and ALT measures will be obtained twice weekly until 
they have normalized. More complete history will be obtained, specifically with respect to medications, 
supplements, recreational drug use history, travel, and chemical exposure. Participants with elevation of 
AST and ALT will also be evaluated for acute viral hepatitis types A, B, C, D, and E; autoimmune hepatitis, 
alcoholic hepatitis, non-alcoholic steatohepatitis, biliary tract disease, and hypoxic/ischemic 
hepatopathy. The liver’s function will be assessed directly via measurement of direct bilirubin and 
nternational normalised ratio (INR).
10.0
Risks
List the reasonably foreseeable risks, discomforts, hazards, or inconveniences to the subjects related the 
subjects’ participation in the research. Include as may be useful for the IRB’s consideration, a description of the 
probability, magnitude, duration and reversibility of the risks. Consider all types of risk including physical, 
psychological, social, legal, and economic risks.  Note: Loss of confidentiality is a potential risk when conducting 
human subject research.

If applicable, indicate which procedures may have risks to the subjects that are currently unforeseeable.

If applicable, indicate which procedures may have risks to an embryo or fetus should the subject be or 
become pregnant.

If applicable, describe risks to others who are not subjects.
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Risks associated with taking oral naltrexone: 

elevated transaminases

depression and mood changes 

abdominal pain 

nausea

headache
Additional clinical risks that could be associated with taking Oral Naltrexone: 

Some pediatric autism literature describes low appetite or occasionally worsening of self-injurious 
behavior while on naltrexone8,11,22,22–25,27. There can also be worsening depression according to the FDA 
label7. These adverse effects are occasionally seen with PHP for eating disorder itself, and therefore we 
monitor for them frequently as a part of the standard of care. Should the subject or the subject’s parent 
wish to withdraw from the study due to these effects, they are free to do so. If these adverse effects are 
felt to be related more to the natural history of eating disorder and not to study intervention; or the 
severity is minor to moderate; the subject may continue to participate in the study if desired. If the 
effect is severe the subject will be withdrawn. 

Oral naltrexone is a pregnancy category C medication7, where there are animal studies that may indicate 
harm to the fetus but no specific human studies on this topic. For this reason, we will test for pregnancy 
in allbirth-assigned females at enrollment using a serum pregnancy screen, and every three weeks 
throughout the study using a urine pregnancy screen. . The majority of patients enrolled in child PHP 
have not yet had coitarche, though in adult PHP a history of sexual activity is more common. 
Other risks of participation include: 
•
Loss of confidentiality
•
Risk of randomization
•
Risk of incidental findings
Anxiety from completing questionnaires
11.0
Potential Benefits to Subjects and Others 
11.1
Potential Benefits to Subjects
Describe the potential benefits that individual subjects may experience from taking part in the research. 
If there is no direct benefit to subjects, indicate as such. Compensation is not considered a benefit. 
Compensation should be addressed in section 14.0.
There is potential direct benefit to participants, as the study intervention may improve eating disorder 
symptoms more rapidly than PHP alone. 
Participants receiving placebo are not expected to have direct benefit.
11.2
Potential Benefits to Others
Include benefits to society or others. 
Others may potentially benefit if oral naltrexone is shown to have some efficacy over PHP alone, as 
there are not many effective pharmacotherapies for eating disorder. If this medication is shown to have 
some beneficial effect in this study, the hope is that eating disorder may have another treatment option. 
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12.0
Sharing Results with Subjects
Describe whether results (study results or individual subject results, such as results of investigational diagnostic 
tests, genetic tests, or incidental findings) will be shared with subjects or others (e.g., the subject’s primary care 
physicians) and if so, describe how information will be shared. 
Any information collected as a part of standard of care will be shared with the participant and the participant’s 
primary care provider as it would have otherwise been shared with them during PHP, usually in weekly-to-
monthly letters to the primary care provider or via patient portal. This includes lab results and survey results. 
Any additional information obtained, such as ABUSI results or liver function tests at 6 weeks, may be shared in 
the same fashion. 
13.0
Subject Payment and/or Travel Reimbursements
Describe the amount, type (cash, check, gift card, other) and timing of any subject payment or travel 
reimbursement. If there is no subject payment or travel reimbursement, indicate as not applicable. 
Extra or Course Credit:  Describe the amount of credit and the available alternatives. Alternatives should be 
equal in time and effort to the amount of course or extra credit offered. It is not acceptable to indicate that the 
amount of credit is to be determined or at the discretion of the instructor of the course. 
Approved Subject Pool: Indicate which approved subject pool will be used; include in response below that 
course credit will be given and alternatives will be offered as per the approved subject pool procedures. 
Participants will be given a $25 Greenphire Clincard at two timepoints during the study: enrollment, and at the 6 
month follow-up, for a total of $50 of reimbursement. Participants will receive the gift card shortly after their 
enrollment in the trial and after completing a 6 month follow up appointment. If the participant withdraws for 
any reason, they will only receive the $25 from enrollment. 
14.0
Economic Burden to Subjects
14.1
Costs
Describe any costs that subjects may be responsible for because of participation in the research.
Participants are expected to incur minimal study-related costs. Any costs of routine care will be billed to 
their insurance providers as a part of routine care or care administered during PHP. Any costs of study-
specific care, such as test article or specific laboratory evaluations, shall be covered by the study itself. 
Participants may incur cost related to travel for the six week and six month follow-ups. They will be 
compensated as described above. There is no cost to parking at the Briarcrest clinic.
14.2
Compensation for research-related injury
If the research involves more than Minimal Risk to subjects, describe the available compensation in 
the event of research related injury.
If there is no sponsor agreement that addresses compensation for medical care for research subjects 
with a research-related injury, include the following text as written - DO NOT ALTER OR DELETE:
It is the policy of the institution to provide neither financial compensation nor free medical treatment 
for research-related injury. In the event of injury resulting from this research, medical treatment is 
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available but will be provided at the usual charge. Costs for the treatment of research-related injuries 
will be charged to subjects or their insurance carriers. 
For sponsored research studies with a research agreement with the sponsor that addresses 
compensation for medical care for research-related injuries, include the following text as written - DO 
NOT ALTER OR DELETE:
It is the policy of the institution to provide neither financial compensation nor free medical treatment 
for research-related injury. In the event of injury resulting from this research, medical treatment is 
available but will be provided at the usual charge. Such charges may be paid by the study sponsor as 
outlined in the research agreement and explained in the consent form.
It is the policy of the institution to provide neither financial compensation nor free medical treatment 
for research-related injury. In the event of injury resulting from this research, medical treatment is 
available but will be provided at the usual charge. Costs for the treatment of research-related injuries 
will be charged to subjects or their insurance carriers.
15.0
Resources Available 
15.1
Facilities and locations
Identify and describe the facilities, sites and locations where recruitment and study procedures will be 
performed. 
If research will be conducted outside the United States, describe site-specific regulations or customs 
affecting the research, and describe the process for obtaining local ethical review. Also, describe the 
principal investigator’s experience conducting research at these locations and familiarity with local 
culture.
Potential subjects will be recruited in a private therapy room in the Adolescent Medicine and Eating 
Disorders Clinic, on the 2nd floor of the Briarcrest building. Study procedures, including survey 
completion, will be completed in this same location. Study blood draws and urine tests will be 
completed at the participant’s preferred outpatient laboratory as a part of standard of care; if the test 
ordered is specific to this study, such as a urine drug screen or the six-week LFT this will be obtained at 
the Penn State Children’s Hospital Outpatient Laboratory.
15.2
Feasibility of recruiting the required number of subjects
Indicate the number of potential subjects to which the study team has access.  Indicate the percentage 
of those potential subjects needed for recruitment.
In 2019, approximately 150 patients meeting criteria for potential inclusion (between ages of 13-18, 
needing PHP level of care in the eating disorder clinic, no diagnosis of gender dysphoria or intellectual 
disability, with diagnoses of anorexia nervosa, bulimia nervosa, or avoidant-restrictive food intake 
disorder) were seen for initial evaluation in the eating disorder clinic. Therefore we hope to be able to 
enroll sixty participants over the course of 12 to 18 months if between 25% and 40% of patients meeting 
criteria choose to or are able to enroll.
15.3
PI Time devoted to conducting the research
Describe how the PI will ensure that a sufficient amount of time will be devoted to conducting and 
completing the research. Please consider outside responsibilities as well as other on-going research for 
which the PI is responsible.
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This is the principal investigator’s primary research obligation and will be completed during 
administrative time. The principal investigator currently has six and a half clinics a week, representing 
weeks of six clinics in a week alternating with weeks of seven clinics. The principal investigator will 
complete this project in her administrative, non-clinical time. 
15.4
Availability of medical or psychological resources
Describe the availability of medical or psychological resources that subjects might need as a result of 
their participation in the study, if applicable.
As the subjects are enrolled in an 8-hour-a-day program for medical and psychological care, they have 
ready access to medical and psychological care should they need it. 
15.5
Process for informing Study Team
Describe the training plans to ensure members of the research team are informed about the protocol 
and their duties, if applicable.
The PI and study coordinator will have weekly meetings as discussed above; with bimonthly updates to 
the rest of the study team. All members of the study team are welcome to attend meetings with the PI 
and study coordinator
16.0
Other Approvals
16.1
Other Approvals from External Entities
Describe any approvals that will be obtained prior to commencing the research (e.g., from engaged 
cooperating institutions IRBs who are also reviewing the research and other required review 
committees, community leaders, schools, research locations where research is to be conducted by the 
Penn State investigator, funding agencies, etc.).
N/A
16.2
Internal PSU Committee Approvals
Check all that apply:
  Anatomic Pathology – Penn State Health only – Research involves the collection of tissues or use of 
pathologic specimens. Upload a copy of “HRP-902 - Human Tissue For Research Form” in CATS IRB. 
  Animal Care and Use – All campuses – Human research involves animals and humans or the use of 
human tissues in animals
  Biosafety – All campuses – Research involves biohazardous materials (human biological specimens 
in a PSU research lab, biological toxins, carcinogens, infectious agents, recombinant viruses or DNA 
or gene therapy).
  Clinical Laboratories – Penn State Health only – Collection, processing and/or storage of extra tubes 
of body fluid specimens for research purposes by the Clinical Laboratories; and/or use of body fluids 
that had been collected for clinical purposes but are no longer needed for clinical use. Upload a copy 
of “HRP-901 - Human Body Fluids for Research Form” in CATS IRB. 
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  Clinical Research Center (CRC) Advisory Committee – All campuses – Research involves the use of 
CRC services in any way.
  Conflict of Interest Review – All campuses – Research has one or more of study team members 
indicated as having a financial interest.
  Radiation Safety – Penn State Health only – Research involves research-related radiation 
procedures. All research involving radiation procedures (standard of care and/or research-related) 
must upload a copy of “HRP-903 - Radiation Review Form” in CATS IRB. 
  IND/IDE Audit – All campuses – Research in which the PSU researcher holds the IND or IDE or 
intends to hold the IND or IDE.
  Scientific Review – Penn State Health only – All investigator-written research studies requiring 
review by the convened IRB must provide documentation of scientific review with the IRB 
submission. The scientific review requirement may be fulfilled by one of the following: (1) external 
peer-review process; (2) department/institute scientific review committee; or (3) scientific review by 
the Clinical Research Center Advisory committee.  NOTE: Review by the Penn State Health Cancer 
Institute (PSCI) Protocol Review Committee or the PSCI Disease Team is required if the study 
involves cancer prevention studies or cancer patients, records and/or tissues. For more information 
about this requirement see the IRB website.
17.0
Multi-Site Study
If this is a multi-site study (i.e., a study in which two or more institutions coordinate, with each institution 
completing all research activities outlined in a specific protocol) and the Penn State PI is the lead investigator, 
describe the processes to ensure communication among sites in the sections below.
[Do not type here]
17.1
Other sites 
List the name and location of all other participating sites. Provide the name, qualifications and contact 
information for the principal investigator at each site and indicate which IRB will be reviewing the study 
at each site.
N/A
17.2
Communication Plans
Describe the plan for regular communication between the overall study director and the other sites to 
ensure that all sites have the most current version of the protocol, consent document, etc.  Describe the 
process to ensure all modifications have been communicated to sites. Describe the process to ensure 
that all required approvals have been obtained at each site (including approval by the site’s IRB of 
record).   Describe the process for communication of problems with the research, interim results and 
closure of the study.
N/A
17.3
Data Submission and Security Plan
Describe the process and schedule for data submission and provide the data security plan for data 
collected from other sites.  Describe the process to ensure all engaged participating sites will safeguard 
data as required by local information security policies.
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N/A
17.4
Subject Enrollment
Describe the procedures for coordination of subject enrollment and randomization for the overall 
project.
N/A
17.5
Reporting of Adverse Events and New Information
Describe how adverse events and other information will be reported from the clinical sites to the overall 
study director. Provide the timeframe for this reporting.
N/A
17.6
Audit and Monitoring Plans
Describe the process to ensure all local site investigators conduct the study appropriately. Describe any 
on-site auditing and monitoring plans for the study.
N/A
18.0
Adverse Event Reporting
18.1
Adverse Event Definitions
For drug studies, incorporate the following definitions into the below responses, as written:
Adverse event
Any untoward medical occurrence associated with the use of the drug in 
humans, whether or not considered drug related
Adverse reaction
Any adverse event caused by a drug
Suspected adverse 
reaction
Any adverse event for which there is a reasonable possibility that the drug 
caused the adverse event.  Suspected adverse reaction implies a lesser degree 
of certainty about causality than “adverse reaction”.

Reasonable possibility.  For the purpose of IND safety reporting, 
“reasonable possibility” means there is evidence to suggest a causal 
relationship between the drug and the adverse event.
Serious adverse 
event or Serious 
suspected adverse 
reaction
Serious adverse event or Serious suspected adverse reaction: An adverse event 
or suspected adverse reaction that in the view of either the investigator or 
sponsor, it results in any of the following outcomes: Death, a life-threatening 
adverse event, inpatient hospitalization or prolongation of existing 
hospitalization, a persistent or significant incapacity or substantial disruption 
of the ability to conduct normal life functions, or a congenital anomaly/birth 
defect. Important medical events that may not result in death, be life-
threatening, or require hospitalization may be considered serious when, based 
upon appropriate medical judgment, they may jeopardize the patient or 
subject and may require medical or surgical intervention to prevent one of the 
outcomes listed in this definition. 
Life-threatening 
adverse event or 
life-threatening 
suspected adverse 
reaction
An adverse event or suspected adverse reaction is considered “life-
threatening” if, in the view of either the Investigator (i.e., the study site 
principal investigator) or Sponsor, its occurrence places the patient or research 
subject at immediate risk of death.  It does not include an adverse event or 
suspected adverse reaction that had it occurred in a more severe form, might 
have caused death.
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Unexpected 
adverse event or 
Unexpected 
suspected adverse 
reaction.  
An adverse event or suspected adverse reaction is considered “unexpected” if 
it is not listed in the investigator brochure, general investigational plan, clinical 
protocol, or elsewhere in the current IND application; or is not listed at the 
specificity or severity that has been previously observed and/or specified.
For device studies, incorporate the following definitions into the below responses, as written:
Unanticipated 
adverse device 
effect
Any serious adverse effect on health or safety or any life-threatening problem 
or death caused by, or associated with, a device, if that effect, problem, or 
death was not previously identified in nature, severity, or degree of incidence 
in the investigational plan or IDE application (including a supplementary plan 
or application), or any other unanticipated serious problem associated with a 
device that relates to the rights, safety, or welfare of subjects.
18.2
Recording of Adverse Events
Address the frequency and process for eliciting adverse event information from research subject, e.g., 
“Research subjects will be routinely questioned about adverse events at study visits.”
In the response, incorporate the following as written:
All adverse events (serious or non-serious) and abnormal test findings observed or reported to study 
team believed to be associated with the study drug(s) or device(s) will be followed until the event (or 
its sequelae) or the abnormal test finding resolves or stabilizes at a level acceptable to the 
investigator.
An abnormal test finding will be classified as an adverse event if one or more of the following criteria 
are met:

The test finding is accompanied by clinical symptoms

The test finding necessitates additional diagnostic evaluation(s) or medical/surgical 
intervention; including significant additional concomitant drug treatment or other therapy
NOTE: Simply repeating a test finding, in the absence of any of the other listed criteria, does 
not constitute an adverse event.

The test finding leads to a change in study drug dosing or discontinuation of subject 
participation in the clinical research study

The test finding is considered an adverse event by the investigator.
Research subjects will be routinely questioned about adverse events at both study visits and routine 
care for PHP. 
All adverse events (serious or non-serious) and abnormal test findings observed or reported to study 
team believed to be associated with the study drug(s) or device(s) will be followed until the event (or its 
sequelae) or the abnormal test finding resolves or stabilizes at a level acceptable to the investigator.
An abnormal test finding will be classified as an adverse event if one or more of the following criteria are 
met:

The test finding is accompanied by clinical symptoms

The test finding necessitates additional diagnostic evaluation(s) or medical/surgical intervention; 
including significant additional concomitant drug treatment or other therapy
NOTE: Simply repeating a test finding, in the absence of any of the other listed criteria, does not 
constitute an adverse event.

The test finding leads to a change in study drug dosing or discontinuation of subject participation in 
the clinical research study
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
The test finding is considered an adverse event by the investigator.
18.3
Causality and Severity Assessments
By submitting this study for review, you agree to the following statement – DO NOT ALTER OR DELETE: 
The investigator will promptly review documented adverse events and abnormal test findings to 
determine 1) if the abnormal test finding should be classified as an adverse event; 2) if there is a 
reasonable possibility that the adverse event was caused by the study drug(s) or device(s); and 3) if the 
adverse event meets the criteria for a serious adverse event.
If the investigator’s final determination of causality is “unknown and of questionable relationship to the 
study drug(s) or device(s)”, the adverse event will be classified as associated with the use of the study 
drug(s) or device(s) for reporting purposes.  If the investigator’s final determination of causality is 
“unknown but not related to the study drug(s) or device(s)”, this determination and the rationale for the 
determination will be documented in the respective subject’s case history.
18.4
Reporting of Adverse Reactions and Unanticipated Problems to the FDA  
18.4.1 Written IND/IDE Safety Reports
For a drug study under an IND, incorporate the following from 21 CFR 312.32 as written – DO 
NOT ALTER OR DELETE: 
The Sponsor-Investigator will submit a written IND Safety Report (i.e., completed FDA Form 
3500A) to the responsible new drug review division of the FDA for any observed or volunteered 
adverse event that is determined to be a serious and unexpected, suspected adverse reaction.  
Each IND Safety Report will be prominently labeled, “IND Safety Report”, and a copy will be 
provided to all participating investigators (if applicable) and sub-investigators.
Written IND Safety Reports will be submitted to the FDA as soon as possible and, in no event, 
later than 15 calendar days following the Sponsor-Investigator’s receipt of the respective 
adverse event information and determination that it meets the respective criteria for reporting.
For each written IND Safety Report, the Sponsor-Investigator will identify all previously 
submitted IND Safety Reports that addressed a similar suspected adverse reaction experience 
and will provide an analysis of the significance of newly reported, suspected adverse reaction in 
light of the previous, similar report(s) or any other relevant information.
Relevant follow-up information to an IND Safety Report will be submitted to the applicable 
review division of the FDA as soon as the information is available and will be identified as such 
(i.e., “Follow-up IND Safety Report”).
If the results of the Sponsor-Investigator’s follow-up investigation show that an adverse event 
that was initially determined to not require a written IND Safety Report does, in fact, meet the 
requirements for reporting; the Sponsor-Investigator will submit a written IND Safety Report as 
soon as possible, but in no event later than 15 calendar days, after the determination was made.
For a device study under an IDE, incorporate the following from 21 CFR 812.150 as written – 
DO NOT ALTER OR DELETE: 
The Sponsor-Investigator will submit a completed FDA Form 3500Ato the FDA’s Center for 
Devices and Radiological Health for any observed or volunteered adverse effect that is 
determined to be an unanticipated adverse device effect.  A copy of this completed form will be 
provided to all participating sub-investigators.
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The completed FDA Form 3500Awill be submitted to the FDA as soon as possible and, in no 
event, later than 10 working days after the Sponsor-Investigator first receives notice of the 
adverse effect.
If the results of the Sponsor-Investigator’s follow-up evaluation show that an adverse effect that 
was initially determined to not constitute an unanticipated adverse device effect does, in fact, 
meet the requirements for reporting; the Sponsor-Investigator will submit a completed FDA 
Form 3500Aas soon as possible, but in no event later than 10 working days, after the 
determination was made.
For each submitted FDA Form 3500A, the Sponsor-Investigator will identify all previously 
submitted reports that that addressed a similar adverse effect experience and will provide an 
analysis of the significance of newly reported adverse effect in light of the previous, similar 
report(s). 
Subsequent to the initial submission of a completed FDA Form 3500A, the Sponsor-Investigator 
will submit additional information concerning the reported adverse effect as requested by the 
FDA.
The Sponsor-Investigator will submit a written IND Safety Report (i.e., completed FDA Form 
3500A) to the responsible new drug review division of the FDA for any observed or volunteered 
adverse event that is determined to be a serious and unexpected, suspected adverse reaction.  
Each IND Safety Report will be prominently labeled, “IND Safety Report”, and a copy will be 
provided to all participating investigators (if applicable) and sub-investigators.
Written IND Safety Reports will be submitted to the FDA as soon as possible and, in no event, 
later than 15 calendar days following the Sponsor-Investigator’s receipt of the respective 
adverse event information and determination that it meets the respective criteria for reporting.
For each written IND Safety Report, the Sponsor-Investigator will identify all previously 
submitted IND Safety Reports that addressed a similar suspected adverse reaction experience 
and will provide an analysis of the significance of newly reported, suspected adverse reaction in 
light of the previous, similar report(s) or any other relevant information.
Relevant follow-up information to an IND Safety Report will be submitted to the applicable 
review division of the FDA as soon as the information is available and will be identified as such 
(i.e., “Follow-up IND Safety Report”).
If the results of the Sponsor-Investigator’s follow-up investigation show that an adverse event 
that was initially determined to not require a written IND Safety Report does, in fact, meet the 
requirements for reporting; the Sponsor-Investigator will submit a written IND Safety Report as 
soon as possible, but in no event later than 15 calendar days, after the determination was made.
18.4.2 Telephoned IND Safety Reports – Fatal or Life-threatening Suspected Adverse Reactions
For a drug study under an IND, incorporate the following from 21 CFR 312.32 into the 
response, as written:
In addition to the subsequent submission of a written IND Safety Report (i.e., completed FDA 
Form 3500A), the Sponsor-Investigator will notify the responsible review division of the FDA by 
telephone or facsimile transmission of any unexpected, fatal or life-threatening suspected 
adverse reaction. 
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The telephone or facsimile transmission of applicable IND Safety Reports will be made as soon 
as possible but in no event later than 7 calendar days after the Sponsor-Investigator’s receipt of 
the respective adverse event information and determination that it meets the respective criteria 
for reporting.
In addition to the subsequent submission of a written IND Safety Report (i.e., completed FDA 
Form 3500A), the Sponsor-Investigator will notify the responsible review division of the FDA by 
telephone or facsimile transmission of any unexpected, fatal or life-threatening suspected 
adverse reaction. 
The telephone or facsimile transmission of applicable IND Safety Reports will be made as soon 
as possible but in no event later than 7 calendar days after the Sponsor-Investigator’s receipt of 
the respective adverse event information and determination that it meets the respective criteria 
for reporting.
18.5
Reporting Adverse Reactions and Unanticipated Problems to the Responsible IRB
By submitting this study for review, you agree to the following statement – DO NOT ALTER OR DELETE: 
In accordance with applicable policies of The Pennsylvania State University Institutional Review Board 
(IRB), the investigator will report, to the IRB, any observed or reported harm (adverse event) 
experienced by a subject or other individual, which in the opinion of the investigator is determined to be 
(1) unexpected; and (2) probably related to the research procedures. Harms (adverse events) will be 
submitted to the IRB in accordance with the IRB policies and procedures.
18.6
Unblinding Procedures
Describe the procedures for unblinding study therapy on a subject, including documentation of this in 
the subject’s source document. Include example(s) here why someone might unblind a study. In most 
cases, the unblinding will be part of managing a serious adverse reaction and will be reported with the 
serious adverse event. However, in cases where unblinding was not associated with a serious adverse 
event, such actions should be reported in a timely manner.
If unblinding becomes necessary, this can be done by submitting a request for and filling out the given 
unblinding form to the pharmacy. Unblinding may be necessary in the event of need for opioid 
painkillers, such as after MVA or other accident. Participants taking study article may not experience 
relief of acute pain from typical doses of opioid pain medications, therefore unblinding for appropriate 
pain management may be appropriate.  
18.7
Stopping Rules
In studies with a primary safety endpoint or studies with high risk to study subjects, provide the rules 
that define the circumstances and procedures for interrupting or stopping the study. If an independent 
Data and Safety Monitoring (DSMB) or Committee (DSMC) is set up for the study, the same stopping 
rules should be incorporated into the safety analysis plan as well.
Monitoring for safety of the study article will be completed in accordance with Federal Food and Drug 
Administration requirements for surveillance of drug-induced liver injury (DILI), in accordance with Hy’s 
law. 
The study will be stopped early in the event of certain specific conditions that are more likely to be due 
to study intervention than to the disease itself. Several possible adverse effects of this medication can 
also be common features of eating disorder or eating disorder treatment itself, including worsening 
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depression, self-injurious behavior, and suicide attempt 7,10,11,17,26–29. The following circumstances would 
trigger immediate suspension of this study with evaluation of safety data and profile:

Death of a study participant

Psychiatric hospitalization for suicidal ideation in any two study participants within a six month 
window

Two participants experiencing elevation of AST or ALT more than three times the upper limit of 
normal for age during the course of the study. 

AST or ALT levels elevated more than five times the upper limit of normal in any participant at 
any time. 

One participant with elevated serum total bilirubin to more than twice the upper limit of normal 
for age with evidence of pure hepatocellular injury (that is, no evidence of obstruction, 
malignancy, genetic disease, other medication effects, viral or bacterial infection) and AST or 
ALT elevation greater than three times the upper limit of normal for age. 

New diagnosis of liver failure of any participant

Any other serious medical or psychiatric condition felt to be potentially related to the study 
article. 
Any suspected case of drug-induced liver injury will be reported to the Food and Drug 
Administration using the specified information provided in the FDA’s document, Guidance for Industry 
Drug-Induced Liver Injury: Premarketing Clinical Evaluation. 
Should any participant demonstrate elevation of AST/ALT above the upper limit of normal for 
age, the study article will be discontinued. AST and ALT measures will be obtained twice weekly until 
they have normalized. More complete history will be obtained, specifically with respect to medications, 
supplements, recreational drug use history, travel, and chemical exposure. Participants with elevation of 
AST and ALT will also be evaluated for acute viral hepatitis types A, B, C, D, and E; autoimmune hepatitis, 
alcoholic hepatitis, non-alcoholic steatohepatitis, biliary tract disease, and hypoxic/ischemic 
hepatopathy. The liver’s function will be assessed directly via measurement of direct bilirubin and 
nternational normalised ratio (INR).
19.0
Study Monitoring, Auditing and Inspecting
19.1
Study Monitoring Plan
19.1.1 Quality Assurance and Quality Control
Include this section if FDA regulations apply to this study (see “WORKSHEET: Drugs (HRP-306)” 
and “WORKSHEET: Devices (HRP-307)”. HRP-306 and HRP-307 can be accessed by clicking the 
Library link in CATS IRB (http://irb.psu.edu). 
Describe how you will ensure that this study is conducted and that the data are generated, 
documented (recorded) and reported in compliance with this protocol, with institutional and 
IRB policies, with Good Clinical Practice guidelines and any other applicable regulatory 
requirements.
Indicate who is responsible for monitoring the conduct of the study and specify how often the 
study will be monitored. 
For single-site studies with low risk, it may be appropriate for the principal investigator to 
monitor the study.
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For multi-center studies or single site studies involving significant risk, an independent monitor 
may be required (e.g., monitoring by the staff of the PSU quality assurance program office(s) or 
by a clinical research organization).
The principal investigator assumes final responsibility for monitoring the safety of this study. 
Monitoring for adverse effects to medication will occur at all biweekly medical appointments as 
a part of routine care during PHP. The principal investigator will monitor the conduct of the 
study at regular monthly intervals. 
Scores from all psychiatric measures obtained at enrollment and three weeks will be recorded in 
REDCap and stored on encrypted drives using minimal PHI. All Excel files will be password-
protected and accessible only to study personnel. If the participant is still in PHP at the six week 
timepoint, psychiatric measures will be obtained and recorded in Excel as before; if the 
participant has completed PHP (and therefore is no longer coming to clinic on a daily basis), the 
participant will be emailed the study metrics via RedCap using secure email. Six month follow-up 
metrics will be obtained via secure email through RedCap as described for some six-week 
follow-ups. Their responses in RedCap will be exported to Excel and then analyzed. Lab results 
will also be stored in Excel using similar encryption. 
The study will be monitored by the Clinical Trial Monitoring Team from the Department of 
Public Health Sciences at Penn State Hershey College of Medicine. The monitors will provide an 
independent review of the regulatory and subject records and the data collected to assure 
compliance with the protocol, GCP, and applicable federal regulations. The monitoring will occur 
at regular intervals after the enrollment of the first subject and the times will be predetermined 
by the monitoring plan developed by the Clinical Trial Monitoring Team.
All information will be available only to study personnel. All files will be maintained on Penn 
State Health drives with password protection. If study personnel needs to access the data 
remotely, they will need two-factor authentication for this process. 
19.1.2 Safety Monitoring
Include this section if FDA regulations apply to this study (see “WORKSHEET: Drugs (HRP-306)” 
and “WORKSHEET: Devices (HRP-307)”. HRP-306 and HRP-307 can be accessed by clicking the 
Library link in CATS IRB (http://irb.psu.edu). 
Indicate the process for identifying, recording and reporting adverse events.
Specify roles for adverse event recording and monitoring. Indicate each staff member’s role in 
the adverse event reporting process. Include the following if applicable:
The Principal Investigator will confirm that all adverse events (AE) are correctly entered into the 
AE case report forms by the coordinator; be available to answer any questions that the 
coordinators may have concerning AEs; and will notify the IRB, FDA, sponsor and/or DSMB of all 
applicable AEs as appropriate. All assessments of AEs will be made by a licensed medical 
professional who is an investigator on the research.
The Research Coordinator will complete the appropriate report form and logs; assist the PI to 
prepare reports and notify the IRB, FDA and/or DSMB of all Unanticipated Problems/SAE’s.
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The Monitor will confirm that the AEs are correctly entered into the case report forms. The 
Monitor will also confirm that the adverse events are consistent with the source documents and 
are reported to the appropriate regulatory bodies as required.
The principal investigator assumes final responsibility for monitoring the safety of this study. 
Monitoring for adverse effects to medication will occur at all biweekly medical appointments as 
a part of routine care during PHP. If a participant develops any observable harm that is probably 
related to the study articles or materials the participant will be withdrawn from the study and 
adverse event reporting per IRB protocol will be performed. 
The Principal Investigator will confirm that all adverse events (AE) are correctly entered into the 
AE case report forms by the coordinator; be available to answer any questions that the 
coordinators may have concerning AEs; and will notify the IRB, FDA, sponsor and/or DSMB of all 
applicable AEs as appropriate. All assessments of AEs will be made by a licensed medical 
professional who is an investigator on the research.
The Research Coordinator will complete the appropriate report form and logs; assist the PI to 
prepare reports and notify the IRB, FDA of all Unanticipated Problems/SAE’s.
20.0
Future Undetermined Research: Data and Specimen Banking
If this study is collecting identifiable data and/or specimens that will be banked for future undetermined 
research, please describe this process in the sections below.  This information should not conflict with 
information provided in section 22 regarding whether or not data and/or specimens will be associated with 
identifiers (directly or indirectly).  If NOT applicable, indicate as such below in all sections.
[Do not type here]
20.1
Data and/or specimens being stored
Identify what data and/or specimens will be stored and the data associated with each specimen.
N/A
20.2
Location of storage
Identify the location where the data and/or specimens will be stored.
N/A
20.3
Duration of storage
Identify how long the data and/or specimens will be stored. If data and/or specimens will be stored 
indefinitely, indicate as such. 
N/A
20.4
Access to data and/or specimens
Identify who will have access to the data and/or specimens.
N/A
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20.5
Procedures to release data or specimens
Describe the procedures to release the data and/or specimens, including: the process to request a 
release, approvals required for release, who can obtain data and/or specimens, and the data to be 
provided with the specimens.
N/A
20.6
Process for returning results
Describe the process for returning results about the use of the data and/or specimens.
N/A
21.0
References
List relevant references in the literature which highlight methods, controversies, and study outcomes.
1
Tatham M, Turner H, Mountford VA, Tritt A, Dyas R, Waller G. Development, psychometric properties and 
preliminary clinical validation of a brief, session-by-session measure of eating disorder cognitions and behaviors: 
The ED-15. Int J Eat Disord 2015; 48: 1005–15.
2
Fairburn CG, Beglin SJ. Assessment of eating disorders: Interview or self-report questionnaire? - EATING 
DISORDER EXAMINATION QUESTIONNAIRE (EDE-Q 6.0) - appendix. Int J Eat Disord 1994; 16: 363–70.
3
Kroenke K, Spitzer RL, Williams JBW. The PHQ-9 Validity of a Brief Depression Severity Measure. J Gen Intern Med 
2001; 16: 606–13.
4
Spitzer RL, Kroenke K, Williams JBW, Löwe B. A brief measure for assessing generalized anxiety disorder: The 
GAD-7. Arch Intern Med 2006; 166: 1092–7.
5
Washburn JJ, Juzwin KR, Styer DM, Aldridge D. Measuring the urge to self-injure: Preliminary data from a clinical 
sample. Psychiatry Res 2010; 178: 540–4.
6
Carver CS, White TL. Behavioral Inhibition, Behavioral Activation, and Affective Responses to Impending Reward 
and Punishment: The BIS/BAS Scales. J Pers Soc Psychol 1994; 67: 319–33.
7
Food and Drug Administration (FDA). Revia (naltrexone hydrochloride Tablets). 2013.
8
Roy A, Roy M, Deb S, Unwin G, Roy A. Are opioid antagonists effective in attenuating the core symptoms of 
autism spectrum conditions in children: A systematic review. J Intellect Disabil Res 2015; 59: 293–306.
9
Newell KM, Sprague RL, Pain MT, Deutsch KM, Meinhold P. Dynamics of Self-Injurious Behaviors. Am J Ment 
Retard 1999; 104: 11–21.
10
Sandman CA, Hetrick WP. Opiate mechanisms in self-injury. Ment Retard Dev Disabil Res Rev 1995; 1: 130–6.
11
Bouvard MP, Leboyer M, Launay JM, et al. Low-dose naltrexone effects on plasma chemistries and clinical 
symptoms in autism: a double-blind, placebo-controlled study. Psychiatry Res 1995; 58: 191–201.
12
Jonas JM, Gold MS. Treatment of antidepressant-resistant bulimia with naltrexone. Int J Psychiatry Med 1986; 16: 
305–9.
13
Goracci A, Di Volo S, Casamassima F, Bolognesi S, Benbow J, Fagiolini A. Pharmacotherapy of binge-eating 
disorder: A review. J. Addict. Med. 2015; 9: 1–19.
14
McElroy SL, Guerdjikova AI, Mori N, Keck PE. Psychopharmacologic Treatment of Eating Disorders: Emerging 
Findings. Curr. Psychiatry Rep. 2015; 17. DOI:10.1007/s11920-015-0573-1.
15
Mcelroy SL, Guerdjikova AI, Blom TJ, et al. A placebo-controlled pilot study of the novel opioid receptor 
antagonist ALKS-33 in binge eating disorder. Int J Eat Disord 2013; 46: 239–45.
16
Marrazzi MA, Bacon JP, Kinzie J, Luby ED. naltrexone use in the treatment of anorexia nervosa and bulimia 
nervosa. Int Clin Psychopharmacol 1995; 10: 163–72.
17
Stancil SL, Adelman W, Dietz A, Abdel-Rahman S. Naltrexone Reduces Binge Eating and Purging in Adolescents in 
an Eating Disorder Program. J Child Adolesc Psychopharmacol 2019; 29: 721–4.
18
Aigner M, Treasure J, Kaye W, Kasper S. World federation of societies of biological psychiatry (WFSBP) guidelines 
for the pharmacological treatment of eating disorders. World J Biol Psychiatry 2011; 12: 400–43.
19
DSM_5_Feeding and Other Eating Disorders Chapter. .
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20
Posner K, Brown GK, Stanley B, et al. The Columbia–Suicide Severity Rating Scale: Initial Validity and Internal 
Consistency Findings From Three Multisite Studies With Adolescents and Adults. Am J Psychiatry 2011; 168: 
1266–77.
21
Horowitz LM, Bridge JA, Teach SJ, et al. Ask suicide-screening questions (ASQ): A brief instrument for the 
pediatric emergency department. Arch Pediatr Adolesc Med 2012; 166: 1170–6.
22
Taylor D V., Hetrick WP, Neri CL, Touchette P, Barron JL, Sandman CA. Effect of naltrexone upon self-injurious 
behavior, learning and activity: a case study. Pharmacol Biochem Behav 1991; 40: 79–82.
23
Willemsen-Swinkels SHN, Buitelaar JK, Nijhof GJ, van Engeland H. Failure of Naltrexone Hydrochloride to Reduce 
Self-Injurious and Autistic Behavior in Mentally Retarded Adults: Double-blind Placebo-Controlled Studies. Arch. 
Gen. Psychiatry. 1995; 52: 766–73.
24
CAMPBELL M, ANDERSON LT, SMALL AM, ADAMS P, GONZALEZ NM, ERNST M. Naltrexone in Autistic Children: 
Behavioral Symptoms and Attentional Learning. J Am Acad Child Adolesc Psychiatry 1993; 32: 1283–91.
25
Eichaar GM, Maisch NM, Augusto LMG, Wehring HJ. Pediatrics Efficacy and Safety of Naltrexone Use in Pediatric 
Patients with Autistic Disorder. Ann Pharmacother 2006; 40: 1086–95.
26
Yale University. Treatment of Binge Eating Disorder in Obesity: Naltrexone/ Bupropion Combination Versus 
Placebo. clinicaltrails.gov. 2014. 
https://clinicaltrials.gov/ct2/show/NCT02317744?term=naltrexone&cond=eating+disorder&cntry=US&draw=2&r
ank=2 (accessed Jan 30, 2020).
27
Kirtley OJ, O’Carroll RE, O’Connor RC. The role of endogenous opioids in non-suicidal self-injurious behavior: 
Methodological challenges. Neurosci. Biobehav. Rev. 2015; 48: 186–9.
28
Campbell K, Peebles R. Eating Disorders in Children and Adolescents: State of the Art Review. Pediatrics 2014; 
134: 582–92.
29
Aderemi TJ. Teachers’ perspectives on sexuality and sexuality education of learners with intellectual disabilities in 
Nigeria. Sex Disabil 2014; 32: 247–58.
22.0
Confidentiality, Privacy and Data Management 
IMPORTANT: The following section is required for all locations EXCEPT Penn State Health and the College of 
Medicine.  Penn State Health and College of Medicine should skip this section and complete “HRP-598 
Research Data Plan Review Form.” In order to avoid redundancy, for this section state “See the Research Data 
Plan Review Form” if you are conducting Penn State Health research. Delete all other sub-sections of section 
22.
For research being conducted at Penn State Health or by Penn State Health researchers only: The research 
data security and integrity plan is submitted using “HRP-598 – Research Data Plan Review Form Application 
Supplement.”  
Refer to Penn State College of Medicine IRB’s “Standard Operating Procedure Addendum: Security and 
Integrity of Human Research Data,” which is available on the IRB’s website. In order to avoid redundancy, for 
this section state “See the Research Data Plan Review Form” if you are conducting Penn State Health 
research. Delete all sub-sections of section 22. 
For all other research: complete the following section.  Please refer to PSU Policy AD95 for information 
regarding information classification and security standards and requirements.  It is recommended that you work 
with local IT staff when planning to store, process, or access data electronically to ensure that your plan can be 
carried out locally and meets applicable requirements.   If you have questions about Penn State’s Policy AD95 or 
standards or need a consultation regarding data security, please contact security@psu.edu. 
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CONSENT FOR RESEARCH
Penn State College of Medicine
Penn State Health
Title of Project:  
A Double-Blind Placebo-Controlled Evaluation of Effectiveness of Oral Naltrexone in 
Management of Adolescent Eating Disorders
Principal Investigator: 
Rosemary Claire Roden, MD
Address: 
905 West Governor Road, Suite 200, Hershey, PA 17033
Telephone Numbers: 
Weekdays: 8:00 a.m. to 5:00 p.m. (717) 531-7235. After hours call (717) 531-8521. 
Ask for the adolescent medicine doctor on 24-hour call.
Subject’s Printed Name: _____________________________
We are asking you to be in a research study.
Whether or not you take part is up to you. You can choose not to take part. You can agree to take part 
and later change your mind. Your decision will not be held against you, and there will be no penalty or 
loss of benefits to which you are entitled.
This form gives you information about the research. Please ask questions about anything that is 
unclear to you and take your time to make your choice.
Some of the people who are eligible to take part in this research study may not be able to give consent 
because they are less than 18 years of age (a minor).  Instead we will ask their parent(s)/guardian(s) to 
give permission for their participation in the study, and we will ask them to agree (give assent) to take 
part.  Throughout the consent form, when we say “you”, we mean you or your child.  
KEY INFORMATION  
The following is a short summary of this study to help you decide whether or not to be a part of this 
research. More detailed information is provided later in this form. If you have any questions, be sure to 
ask the study team. 
Why am I being invited to take part in this research study?
We are asking you to take part in this voluntary research study because you have an eating disorder and are 
receiving care in the Partial Hospitalization Program (PHP) for Eating Disorders at Penn State Children’s 
Hospital, Division of Adolescent Medicine
What is the purpose of this research study?
The purpose of this study is to determine the effect of oral naltrexone in adolescents seeking treatment 
for eating disorder. This drug is approved for treatment of another condition but is not approved for the 
use proposed in this research. 
Approximately 60 people will take part in this research study at Hershey Medical Center. 
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How long will the research study last?
The study lasts six months. 
What will I need to do?
You will complete all questionnaires and surveys as provided to you during care in program treatment. If 
you are in the adult Partial Hospitalization Program, you will complete two additional self-report measures 
along with the rest of the measures you take every three weeks during treatment. In addition to your 
regular eating disorder care, you will be provided either study medicine or placebo (a pill that looks like the 
study medication, but which contains an inactive substance instead) to take every day for six weeks. We 
also ask that you complete two extra short surveys at the start of treatment, and again at three weeks, six 
weeks, eight/nine weeks for post-treatment evaluation, and six months after starting treatment. 
You will need to take a urine drug test at enrollment. The results of this test will not go into the medical 
record. 
We ask that you have blood testing at enrollment, week three, and week six to assess for liver problems 
related to the study medicine. If you are already having bloodwork done as part of standard of care, we will 
not ask you to have the same bloodwork done twice. 
All people assigned female at birth participating in this study will have to take a blood test for pregnancy at 
enrollment, and urine pregnancy tests every three weeks for six weeks.
 
What are the main risks of taking part in the study?
For this study, the main risks include loss of confidentiality, risk of randomization, emotional discomfort, 
and risk of incidental findings during the research study. Study team members will do their best to ensure 
that these risks will not occur during the research trial. 
The main risks to know about the study drug are: nausea, possible worsening of mood or depression, and 
pain related to blood draws. Other risks related to the study medication include liver injury and increased 
thoughts of suicide or self-harm. People using opioid medications may experience opioid withdrawal as a 
result of the study medication.
The risks of the study medication in pregnancy are not known. It is not known if the study medication can 
be passed through breast milk. 
What are the possible benefits to me that may reasonably be expected from being in the research? 
We cannot promise any benefits to you from taking part in this study. However, possible benefits include 
faster recovery from your eating disorder. Results of the study may benefit other people in the future by 
helping us learn more about eating disorder treatment
What happens if I do not want to be in this research?
Participation in research is completely voluntary. You can decide to participate or not to participate. It will 
not affect the care you get in PHP.
DETAILED INFORMATION
The following is more detailed information about this study in addition to the information listed above.
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1.   Why is this research study being done?   
The purpose of this study is to determine the effect of oral naltrexone in adolescents seeking 
treatment for eating disorder. This drug is approved for treatment of another condition but is not 
approved for the use proposed in this research. Oral naltrexone is FDA-approved to treat alcohol 
dependence and to block the effects of opioid medications and drugs. 
Oral naltrexone is contraindicated in: people receiving opioid painkillers, people dependent on 
opioids including those maintained on agonists or partial agonists, people in opioid withdrawal, 
anyone with a positive urine screen for opioids, or anyone with a sensitivity to naltrexone or any 
components of the products. 
This drug has no approved use in patients 17 years of age and younger. 
Approximately 60 people will take part in this research study at Hershey Medical Center. 
2.   What will happen in this research study?
You will be randomly assigned to receive one of the two study treatments, either oral naltrexone or 
placebo. This means that whichever study treatment you receive will be determined purely by chance, 
like flipping a coin. You will have an equal chance of receiving any one of the study treatments. Neither 
you nor the research team will know which study treatment you are receiving, but we will be able to get 
this information quickly if we need it to ensure your safety.
You will receive the same treatment in our eating disorder clinic if you decide to enroll in this study or 
not. If you decide to participate in this study, in addition to routine care you will be randomly assigned to 
take a daily pill of either study medication (naltrexone) or placebo every day for six weeks. You will also 
be asked to fill out various surveys as a part of routine care for eating disorder. In addition to our routine 
surveys, we will ask you to fill out two extra surveys at enrollment, three weeks, six weeks, weeks 8/9 
post-treatment, and six months after enrollment. 
All patients are asked to complete bloodwork at enrollment into our partial hospitalization program for 
eating disorders. For those who enroll in this study, they will have a urine drug screen at enrollment. You 
will not be responsible for these costs, and the results will not go in your medical record. Participants will 
also need to have blood tests every three weeks for 6 weeks and at the study start if not required as part 
of standard of care. Women and girls participating in the study will need a blood test for pregnancy at 
enrollment and urine tests for pregnancy at weeks three and six. You will not be responsible for the costs 
of the pregnancy tests (if you need them), or for the blood tests.
Blood testing will be performed by venipuncture, or a needle inserted into a vein by a trained 
professional.  The total volume of blood draw for this study is expected to be less than 18ml over the 
entirety of the study. This is about the same as three and a half tablespoons. 
If you participate in this study, we will give you a $25 Greenphire Clincard, which is an electronic gift 
card that can be used as a debit or credit card. 
We ask that you return for a follow-up visit at 6 months after enrollment, which is a part of routine eating 
disorder care. In addition to routine care, we ask that you complete the same battery of surveys. If your 
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medical provider decides that you do not need to come in for routine medical care, we will send you the 
surveys via secure email, and you will still have the opportunity to get an additional $25 on your Clincard. 
Participants will receive a total of $50 in Greenphire Clincards.
We have developed the following table to show when all study interventions are planned to happen. 
Thinks marked with a superscript o are things that only happen for the study, and are not a part of 
routine care in PHP or IOP. 
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Intervention
Pre-Enrollment 
Screening: Medical
Enrollment
Week 1
Week 2
Week 3
Week 4
Week 5
Week 6 (end of 
treatment) 
Week 8-9 (post-
treatment)
Six Months
Initial Medical 
Assessment
x
Subsequent Medical 
Assessment, including 
comprehensive review 
of systems
x
x
x
x
x
Initial Psychiatry 
Assessment
x
Subsequent Psychiatric 
Assessment, including 
suicidal ideation
x
x
x
x
x
x
x
x
Discussion of risks and 
benefits, inclusion and 
exclusion criteriao
x
Consent/Assento
x
$25 Greenphire 
Clincardo
x
x
Urine Drug Screeno
x
Serum Pregnancy Test 
(female participants)o
x
Urine Pregnancy Test 
(female participants)o
x
x
Administer Study 
Articleo
x
x
x
x
x
x
EKG
x
AST
x
xo
xo
ALT
x
xo
xo
Total Bilirubin
x
xo
xo
Direct bilirubin
x
xo
xo
Heart Rate
x
x
x
x
x
x
x
x
x
BMI
x
x
x
x
x
x
x
x
x
Height
x
x
x
x
x
x
x
x
x
Weight
x
x
x
x
x
x
x
x
x
Blood Pressure
x
x
x
x
x
x
x
x
x
Temperature
x
x
x
x
x
x
x
x
x
Adverse event 
monitoring
x
x
x
x
x
x
x
x
Suicidal Ideation 
Screening (ASQ for age 
<17 or C-SSRS for age 
18+)
x
x
x
x
x
x
x
x
x
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ED-15
x
x
x
x
X
x
EDE-Q
x
x
x
x
X
x
ABUSIo
x
x
x
x
X
x
PHQ-9
x
x
x
x
X
x
GAD7
x
x
x
x
X
x
BIS/BASo
x
x
x
x
X
X
A majority of these screening tests would be done even if you do not take part in the research study. 
These tests are routine for patients with your disease who are about to start therapy.
The study team will monitor the content of your questionnaires during the six months you are enrolled 
in this study but will not be responding to any of the information in “real time.” This means we may not 
be immediately aware of any entries you make that could indicate health treatment is needed. If you are 
feeling depressed or suicidal, or are having difficulty coping, please contact your primary doctor or go to 
your local emergency room as soon as possible.
If you are pregnant or nursing, you will be excluded from participation in the study. If you are a sexually 
active person, you must be willing to use a highly effective method of birth control, such as intrauterine 
device, birth control pills, contraceptive implant, contraceptive patches, contraceptive vaginal ring, or 
injectable contraception. Condoms alone are not considered a highly effective form of birth control. If 
you become pregnant during the study, we will have to take you out of the study. You can continue with 
your eating disorder care even if you are withdrawn from the study.
If, during the course of this study, you engage in sex where a penis enters a vagina either without the use 
of contraception or with contraceptive failure (such as a broken condom with no second method of 
contraception), you will be offered a prescription for emergency contraceptive (ulipristal acetate or 
levonorgesterel 1.5mg) within 72 hours after sex and pregnancy testing 14 days after the episode of sex 
with referral according to results. You will also be withdrawn from the study. You can continue with your 
eating disorder care even if you are withdrawn from the study.
If your urine drug screen is positive for opioid substances, you will be provided a referral for addiction 
treatment services, which you may choose to accept or to decline. You will be excluded from participation 
in the study.
What are my responsibilities if I take part in this research? 
If you take part in this research, your major responsibilities will include: 

Taking your medicine every day

Blood tests at enrollment as part of routine care, and blood tests every three weeks for 6 weeks (at 
week 3 and week 6). 

Urine pregnancy tests at weeks three and six for all assigned female patients

For your safety, you must tell the study doctor or nurse about all the prescription drugs, herbal 
products, over-the-counter drugs (OTC), vitamins and other supplements you are taking.  Check with 
the study doctor before starting any new medicines (including prescription, OTC drugs, vitamins and 
herbal supplements) or changing doses of medications that you are already taking.  

You will be asked to complete two surveys every three weeks in addition to the routine surveys in 
PHP and IOP

Disclosure of coitus during study participation if there was no use of contraception or the conception 
failed
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3.   What are the risks and possible discomforts from being in this research study?  
You will be assigned to a treatment program by chance. The treatment you receive may prove to be 
less effective or to have more side effects than the other research treatment(s) or other available 
treatments. If you are in the group that receives placebo, your condition will be treated only with 
the standard of care and not with additional study medication.
There is a risk of loss of confidentiality if your medical information or your identity are obtained by 
someone other than the investigators, but precautions will be taken to prevent this from happening.
Oral naltrexone is associated with the following adverse effects: nausea, possible worsening of 
mood or depression, liver injury and increased thoughts of suicide or self-harm. People using opioid 
medications may experience opioid withdrawal as a result of the study medication.
If you are a person who can become pregnant: You should understand that you must not be 
pregnant when you enter the study. You also must not become pregnant during the study. If you are 
or become pregnant, the treatment involved in this study may hurt you or the baby. It is important 
for you to understand that you need to use prescription birth control while on this study. Check with 
your doctor about what kind of birth control methods to use and how long to use them. Some birth 
control methods might not be approved for use in this study. You may be tested for pregnancy to 
make sure that you are not pregnant. If you become pregnant during this study, you must notify the 
study doctor or study staff right away.
Some of the questionnaires and interview questions will be about your feelings, such as depression, 
sadness and anxiety. If your responses indicate that you are having suicidal thoughts or may be at 
risk of hurting yourself or others, we will need to respond to that. The response may involve 
breaking confidentiality and contacting a licensed mental health professional or a law enforcement 
officer. All patients who express any suicidal thoughts will be referred for follow-up mental health 
counseling.
You may get tired or bored when we are asking you questions or you are completing questionnaires. 
You do not have to answer any question you do not want to answer.
4.   What are the possible benefits from being in this research study?   
4a. What are the possible benefits to me?
There is no guarantee that you will benefit from this research. If you are assigned to the active study 
drug group, the possible benefits you may experience from this research study include faster 
recovery from eating disorder. If you are assigned to the placebo group, you are not expected to 
benefit from this research.    
4b. What are the possible benefits to others?
The results of this research may guide the future treatment of eating disorders
 
5.   What other options are available instead of being in this research study?
You may choose not to be in this research study. You do not have to take part in this study to be treated 
for your condition. If you choose not to participate, you will still be offered standard treatment at the 
partial hospital program, which includes completing other clinic questionnaires. 
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6.   How long will I take part in this research study?
You will be enrolled in the study for six months. This does not change how long you will be in our eating 
disorder program. You will be given study medication or placebo weekly while you are in programming 
or for six weeks, whichever happens first. You will be asked to visit the research site once after you 
finish PHP. 
7.   How will you protect my privacy and confidentiality if I decide to take part in this research study?
7a.  What happens to the information collected for the research?
Efforts will be made to limit the use and sharing of your personal research information to people who 
have a need to review this information. Reasonable efforts will be made to keep the personal 
information in your research record private. However, absolute confidentiality cannot be guaranteed, 
and there may be situations where disclosure is required by law. 
In our research files at Penn State Health (PSH) and Penn State College of Medicine (PSU) we will 
include these identifiers: name/initials, electronic mail address, and medical record numbers.

A list that matches your name with your code number, which is a unique number used to identify 
you in the research record, will be kept in a locked drive in Dr. Roden’s computer. No physical list 
will be kept. 

Your research records will be labeled with your study code number and will be kept in a safe area in 
Dr. Roden’s research office.

 Results of some of the research-related clinical tests (including but not limited to liver function 
tests and pregnancy tests) will be kept in your PSH medical record. Results of your urine drug 
screen will not be in the medical record.

Results from this study will be provided upon request. The status and available results of the study 
are visible to the general public on clinicaltrials.gov, and are updated on a regular basis.
7b. What will happen to my research information and/or samples after the study is completed?
We will not be storing any of your information or biological samples for use in future studies. Your 
information and biological samples will not be shared with any other investigators for use in future 
studies. 
Most tests done on samples in research studies are only for research and have no clear meaning for 
health care.  If the research with your identifiable information or samples gives results that do have 
meaning for your health, the researchers will contact you to let you know what they have found. 
No biological specimens will be used for commercial profit. 
No biological specimens will be used for genomic sequencing. 
7c. How will my identifiable health information be used?
In general, under federal law (including the Health Insurance Portability and Accountability Act – HIPAA 
or privacy laws) your health information is private.  By signing this form, you are authorizing us to 
collect, use, and disclose your identifiable health information, sometimes referred to as “Protected 
Health Information” or “PHI” under HIPAA, for the purposes of this research study.  We will use and 
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disclose your information only as described in this form, in the PSH Privacy Notice, and as may be 
required or allowed under the applicable privacy laws.
The research team may use the following health information:

Past, present, and future medical records, including identifiable information

New health information from tests, procedures, visits, interviews, or forms filled out as part of 
this research study.
The following people/groups may see, use, and share your identifiable health information:

PSH/PSU research staff involved in this study

The PSH/PSU Institutional Review Board (IRB), a group of people who review the research study 
to protect subjects’ rights and welfare

The PSH/PSU Human Subjects Protection Office

The PSH/PSU Research Quality Assurance Office

Non-research staff within PSH/PSU who need this information to do their jobs (such as for 
treatment, payment (billing), or health care operations)

Federal and state agencies (such as the U.S. Food and Drug Administration, the Office for 
Human Research Protections, the Department of Health and Human Services, the National 
Institutes of Health, and other U.S. or foreign government bodies that oversee or review 
research)

People or groups that we hire to do work for us, such as data storage companies, insurers, and 
lawyers

Organizations that provide independent accreditation and oversight of hospitals and research

Public health and safety authorities (for example, if we learn information that could mean harm 
to you or others, we may need to report this, as required by law)

The PSH/PSU pharmacy

The sponsor(s) of this study, monitors and auditors, and other people or groups it hires to help 
perform this research
These groups may also review and/or copy your original PSH/PSU records while looking at the results of 
the research study.  It is possible that some of the other people/groups who receive your health 
information may not be required by Federal privacy laws to protect your information. We share your 
information only when we must, and we ask anyone who receives it from us to protect your privacy. 
Sometimes a Principal Investigator or other researcher moves to a different institution. If this happens, 
your identifiable health information and samples may be shared with that new institution and their 
oversight offices. PHI will be shared securely and under a legal agreement to ensure it continues to be 
used under the terms of this consent and HIPAA authorization.
We may remove identifying information from your protected health information.  Once we do this, the 
remaining information will not be subject to the privacy laws.  Information without identifiers may be 
used or disclosed with other people or organizations for purposes besides this study.
Because research is an ongoing process, your permission for the use, storage and sharing of your health 
information will continue indefinitely. 
Your privacy rights:
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
You have the right to refuse to sign this form that allows us to use and share your health 
information for research; however, if you don’t sign it, you will not be able to take part in this 
research study.

You have the right to withdraw your permission for us to use or share your health information 
for this research study. If you want to withdraw your permission, you must notify the person in 
charge of this research study in writing using the address on the front of this form. Once 
permission is withdrawn, you cannot continue to take part in the study. 

If you withdraw your permission, we will stop collecting health information about you for this 
study; we may continue to use and share your health information that we already have if it is 
necessary for safety and scientific soundness of the research study; and we will not be able to 
take back information that has already been used or shared with others. 

You have the right to see and get a copy of your health information that is used or shared for 
treatment or for payment. However, you may not be allowed to see or copy certain health 
information that is a part of this research study. This is only for the period of the study. You will 
be allowed to see that information when the entire research study is complete. 
           
8.   What are the costs of taking part in this research study?
8a. What will I have to pay for if I take part in this research study? 
For costs of tests and procedures that are only being done for the research study:

The naltrexone or placebo will be provided by the Children’s Miracle Network at no cost to you 
while you take part in this study. 

You and/or your insurance company will not be charged for the cost of any tests or procedures 
that are required as part of the research and are outside the standard of care (what is normally 
done) for your condition. 
For costs of medical services for care you would receive even if you were not in this research study:

You and/or your insurance company will be responsible for the cost of routine medications, 
tests and procedures that you would receive even if you were not in this research.

You and/or your insurance company will be billed for the costs of these routine tests and 
procedures in the usual manner.

You will be responsible for any co-payments, co-insurance and deductibles that are standard 
for your insurance coverage. 

You will be responsible for any charges not reimbursed by your insurance company.

Some insurance companies may not pay for routine costs for people taking part in research 
studies. Before deciding to be in this research you should check with your insurance company 
to find out what they will pay for.
If you have any questions about costs and insurance, ask the research study doctor or a member of the 
research team. 
8b. What happens if I am injured as a result of taking part in this research study?
It is possible that you could develop complications or injuries as a result of being in this research study. 
If you experience a side effect or injury and emergency medical treatment is required, seek 
treatment immediately at any medical facility. If you experience a side effect or injury and you 
believe that emergency treatment is not necessary, you should contact the principal investigator 
listed on the first page of this consent form as soon as possible and the principal investigator will 
arrange for medical treatment. You should also let any health care provider who treats you know 
that you are in a research study.
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PSH/PSU compensation for injury

There are no plans for PSH/PSU to provide financial compensation or free medical treatment 
for research-related injury. 

If an injury occurs, medical treatment is available at the usual charge. 

Costs will be charged to your insurance carrier or to you. 

Some insurance companies may not cover costs associated with research injuries. 

If these costs are not covered by your insurance, they will be your responsibility.
When you sign this form you are not giving up any legal right to seek compensation for injury. 
9.
Will I be paid to take part in this research study?
You will receive a $25 Greenphire Clincard at enrollment and six months for your participation in this 
research study for a total of $50. If you do not complete the study for any reason, you will be paid 
for the visits you have completed. This reimbursement will be issued by an external company called 
Greenphire, which will issue your reimbursement. You will be issued a ClinCard, which is a debit card 
that your funds are loaded onto and can be used at your discretion.  The research team will give 
Greenphire some personal information about you, as described below. Greenphire will only use your 
personal information to process this reimbursement and will not share it with anyone for any other 
purpose. Details of the debit card system are explained on an additional sheet. If you lose the card, 
you may be responsible for the replacement fee. 
 
When a visit is completed, funds will be approved and loaded onto your card.  The funds will be 
available within 2-3 business days. In order to assign a ClinCard to you and load funds onto the 
ClinCard, Greenphire will need your Study/Subject ID, Name, Address, and date of birth.
10. Who is paying for this research study?
The institution will be reimbursed by the research sponsor, the Children’s Miracle Network, for use 
of this site’s facilities and for the work the research staff does to conduct this research. No one on 
the research team will receive a direct payment or an increase in salary for conducting this study.
11.  What are my rights if I take part in this research study?
Taking part in this research study is voluntary. 

You do not have to be in this research. 

If you choose to be in this research, you have the right to stop at any time. 

If you decide not to be in this research or if you decide to stop at a later date, there will be no 
penalty or loss of benefits to which you are entitled. 
If you decide to leave the research, you may still participate in PHP. If you decide to leave the research, 
contact the investigator so that the investigator can stop the pharmacy from preparing more medication for 
you.
If you participate in this study and you feel the study medication helped you, you can ask the healthcare 
provider in the clinic to prescribe it for you again.
If you stop being in the research, already collected data may not be removed from the study database. You 
will be asked whether the investigator can collect medical information from your routine medical care. If 
you agree, this data will be handled the same as research data. If you withdraw completely from the 
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research study, no further information will be collected and your participation will end. You may 
discontinue taking part at any time without penalty or loss of benefits to which you are otherwise entitled. 
 Your research doctor may take you out of the research study without your permission. 

Some possible reasons for this are: continuing the research would be harmful, your condition 
has become worse, you become pregnant, you did not follow the instructions of the study 
doctor, you experience serious side effects, or you need treatment with opioid medications for 
any reason. 

Also, the sponsor of the research may end the research study early. 

If your participation ends early, you may be asked to visit the research doctor for a final visit. 
 During the course of the research you will be provided with any new information that may affect your 
health, welfare or your decision to continue participating in this research.
12. If I have questions or concerns about this research study, whom should I call?    
Please call the head of the research study (principal investigator), Dr. Rosemary Claire Roden at (717) 531-
7235 or the Adolescent Medicine doctor on 24-hour call at (717) 531-8521 if you:

Have questions, complaints or concerns about the research.

Believe you may have been harmed by being in the research study.  
You may also contact the research protection advocate in the PSH Human Subjects Protection Office (HSPO) 
at (717) 531-5687 if you:

Have questions regarding your rights as a person in a research study.

Have concerns, complaints or general questions about the research. 

Have questions about your privacy and the use of your personal health information. 

You may also call this number if you cannot reach the research team or wish to offer input or to talk 
to someone else about any concerns related to the research. 
You may visit the Penn State College of Medicine’s Clinical Research web site at 
http://med.psu.edu/clinical-research/faqs  for:

Information about your rights when you are in a research study; 

Information about the Institutional Review Board (IRB), a group of people who review the research 
to protect your rights; and 

Links to the federal regulations and information about the protection of people who are in research 
studies. If you do not have access to the internet, copies of these federal regulations are available 
by calling the HSPO at (717) 531-5687.
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. 
This Web site will not include information that can identify you. At most, the Web site will include a 
summary of the results. You can search this Web site at any time.
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INFORMED CONSENT AND AUTHORIZATION TO TAKE PART IN RESEARCH 
Signature of Person Obtaining Informed Consent
Your signature below means that you have explained the research to the subject or subject 
representative, provided the subject or subject representative an opportunity to discuss and consider 
whether or not to participate in the research, and have answered any questions about the research.
______________________________
__________
______
________________
Signature of person who explained this research Date
Time
Printed Name
(Only approved investigators for this research may explain the research and obtain informed consent.)  
Signature of Person Giving Informed Consent and Authorization
Before making the decision about being in this research you should have:

Discussed this research study with an investigator, 

Read the information in this form, and

Had the opportunity to ask any questions you may have. 
Your signature below means that you have received this information, have asked the questions you currently 
have about the research and those questions have been answered. You will receive a copy of the signed and 
dated form to keep for future reference.
Signature of Subject
By signing this consent form, you indicate that you voluntarily choose to be in this research and authorize 
your information to be used and shared as described above. 
___________________________
__________
______
________________ 
Signature of Subject
Date
Time
Printed Name
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Signature of Parent(s)/Guardian for Child
By signing this consent form, you indicate that you permit your child to be in this research and authorize 
your child’s information to be used and shared as described above. 
_____________________________________________
Printed name of child
___________________________
__________
______
________________ 
Signature of Parent/Guardian
Date
Time
Printed Name
 Parent
 Individual legally authorized to consent to the child’s general medical care. (See note below.)
Note:  Investigators are to ensure that individuals who are not parents can demonstrate their legal authority to 
consent to the child’s general medical care. Contact legal counsel if any questions arise.
ASSENT FOR RESEARCH 
The research study has been explained to you. You have had a chance to ask questions to help you 
understand what will happen in this research. You will have a urine drug test, and it must be negative to 
participate in this research study. If you are 13 years of age or younger at the time this consent/assent form 
is signed, and your urine drug test comes back positive, your parents will be notified of this information. If 
you are 14 years of age or older at the time this consent/assent is signed, and your urine drug test comes 
back positive, your parents will not be notified of this information without your consent. However, your 
parents may find out that you are using drugs as you will not be able to take part in this research. If you are 
a female capable of becoming pregnant you will be tested for pregnancy. The results of your test will not be 
shared with your parent/guardian without your permission. However, your parents may find out if you are 
pregnant because you will no longer be able to take part in this research.
You Do Not have to be in the research study. If you agree to participate and later change your mind, you can 
tell the researchers, and the research will be stopped. 
You have decided:
(Initial one)
___ To take part in the research.
___ NOT to take part in the research.
__________________________________
______
_________________________
Signature of subject
Date
Printed Name
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