Clinical trial NCT03205423
Conditions: Opioid-use Disorder Alcohol Use Disorder
Sponsor: New York State Psychiatric Institute
Start date: 2017-08-01; Completion date: 2021-12-30
Enrollment: 17 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The present proposal will evaluate the ability of gabapentin maintenance to reduce the abuse liability of alcohol, oxycodone, and alcohol in combination with oxycodone in participants with both Opioid Use Disorder and Alcohol Use Disorder.

Detailed description:
Currently, the abuse of prescription opioid medications is a pervasive problem in the U.S. In addition, co-abuse of opioids and alcohol represents a significant problem from the perspective of increased toxicity and decreased success in treatment. Surprisingly few studies have examined the effects of combined administration of opioids and alcohol in humans, and no clinical studies have examined the reinforcing effects of this combination. The current 8-9-week inpatient study will systematically evaluate gabapentin because it shows promise for treating both opioid and alcohol use disorders (OUD and AUD). The guiding principle is that a medication's effects on positive subjective responses and reinforcing effects are the best laboratory procedures to date in predicting its clinical efficacy. We will examine the ability of gabapentin (0 mg or 1800 mg) to alter opioid-, alcohol-,and combined opioid/alcohol-mediated responses. Participants will meet DSM-5 criteria for moderate-severe OUD and be physically dependent on opioids. In addition, participants will meet DSM-5 criteria for moderate-severe AUD, but they will not be physically dependent on alcohol. All of the participants will be maintained on oral morphine throughout the study and different doses of gabapentin will be evaluated.

Arms: arm 1: once daily at 8am arm 2: once daily at 8am
Interventions: intervention 1: Gabapentin
Intervention descriptions: intervention 1: Maintenance medication under investigation for its ability to alter the subjective and reinforcing effects of experimenter-administered doses of oxycodone and alcohol.

Protocol documents:
Prot_SAP_ICF_002.pdf: 
                                          NEW YORK STATE PSYCHIATRIC INSTITUTE        
INSTITUTIONAL REVIEW BOARD
MEMORANDUM 
March 6, 2020
TO: 
Dr.  Sandra Comer
FROM: 
Dr. Edward Nunes, Co-Chair 
Dr. Agnes Whitaker, Co-Chair 
SUBJECT: 
APPROVAL NOTICE: CONTINUATION 
Expedited per 45CFR46.110(b)(1)(f)(8)(c)
Your protocol #7476 entitled Medication Development for Opioid and Alcohol Abuse: 
Laboratory Study in Humans (version date 03-06-2020) and consent forms have been approved 
by the New York State Psychiatric Institute - Columbia University Department of Psychiatry 
Institutional Review Board from April 3, 2020 to April 2, 2021.
Consent requirements: 
    
Not applicable: Data Analysis Only
    
    
Signature by the person(s) obtaining consent is required to document the consent process         
    
required.
    Approved for recruitment of subjects who lack capacity to consent:  
Yes            
    Field Monitoring Requirements:
Special:                    
used to obtain consent for participation in this study. 
  A progress report and application for continuing review is required 2 months prior to the  
expiration date of IRB approval. 
  Changes to this research may be not be initiated without the review and approval of the  IRB 
except when necessary to eliminate immediate hazards to participants. 
ted problems involving risks to subjects or others must be reported 
immediately to the IRB.  Please refer to the PI-IRB website at http://irb.nyspi.org for Adverse Event 
Reporting Procedures and additional reporting requirements.
CC: 
RFMH Business Office (DA039169)
CU Grants & Contracts (subcontract)
EN/AW/Scr 
Signed copy on file at IRB
             v. 4/19/13 


Protocol Summary Form
7476
Comer, Sandra
Page 1 of 27
Protocol Title:
Medication Development for Opioid and 
Alcohol Abuse: Laboratory Study in 
Humans
Protocol Number:
7476
First Approval:
05/31/2017
Expiration Date:
04/02/2021
Version Date:
03/06/2020
Clinic:
Opioid Research Laboratory
Contact Principal Investigator:
Sandra Comer, PHD
Email: sdc10@columbia.edu
Telephone: 646-774-6146
Co-Investigator(s):
Suzette Evans, PHD
Richard Foltin, PHD
Jeanne Manubay, MD
Jermaine Jones, PHD
Shanthi Mogali, MD
Research Chief:
Frances Levin, MD
Cover Sheet
Choose ONE option from the following that is applicable to your study
If you are creating a new protocol, select "I am submitting a new protocol." As 5 Year Renewals are no 
longer required, this option remains for historical purposes.
I am submitting an annual continuation without modifications 
Division & Personnel
Division
What Division/Department does the PI belong to?
Division on Substance Use Disorders
Within the division/department, what Center or group are you affiliated with, if any? 
Opioid Laboratory
Unaffiliated Personnel


Protocol Summary Form
7476
Comer, Sandra
Page 2 of 27
List investigators, if any, who will be participating in this protocol but are not affiliated with New York 
State Psychiatric Institute or Columbia University. Provide: Full Name, Degrees and Affiliation.
Not applicable 
Application for Continuation of Research
Status
Current Status of Study: 
All research interventions were completed. Only data analysis is ongoing.
Summary of Experiences to Date
Please provide a summary of scientific progress of the study and the experience of research participants, to 
date. This requirement is designed to allow for the investigator and the IRB to reassess the study’s risks and 
benefits in terms of developments in the field, changing practice patterns, and new IRB policies and 
procedures.
A total of 13 participants completed the study procedures, which were generally well tolerated with the 
exception of hypertension experienced by 2 participants as reported previously. Preliminary analyses of our 
data suggest that gabapentin increases subjective ratings of Drug Liking, High, Sedated, Would Pay, Potent, 
and High Quality. However, it did not significantly alter the respiratory effects of oxycodone, alcohol, or the 
combination. We are working on the manuscript for publication. 
Funding
Have there been any changes in funding status since the prior approval? 
No
Have the principal investigator and other investigators made all required disclosures of financial interest in 
the study sponsor/product?
Yes
Summary
Have there been any study findings, recent literature, or untoward events occuring here or at other sites in 
the past year which might affect the analysis of the safety, risks or benefits of study participation? 
No
Have there been any serious adverse events (serious and/or unanticipated problems involving risks to 
subjects or others at this site which occured in the past year)? 
No
Have all study staff with a significant role in the design or implementation of the human subject components 
of this study received required training in human research subject protections?
Yes
Is the study covered by a certificate of confidentiality? 


Protocol Summary Form
7476
Comer, Sandra
Page 3 of 27
Yes
Certificate expiration date (mm/dd/yyyy) 
06/15/2023
Overall Progress
Approved sample size
24
Total number of participants enrolled to date
17
Number of participants who have completed the study to date 
13
Have there been any significant deviations from the anticipated study recruitment, retention or completion 
estimates? 
No
Comments / additional information 
Sample Demographics
Specify population
Participants meeting criteria for OUD and AUD
Total number of participants enrolled from this population to date 
17
Gender, Racial and Ethnic Breakdown 
1 Female, 16 Male
2 Hispanic, 15 Non-Hispanic
5 White, 12 Black 
Summary of Current Year's Enrollment and Drop-out 
Number of participants who signed consent in the past year
4
Did the investigator withdraw participants from the study? 
No
Did participants decide to discontinue study involvement? 
No
Procedures
To create the protocol summary form, first indicate if this research will include any of the following 
procedures


Protocol Summary Form
7476
Comer, Sandra
Page 4 of 27
Medication Trial
Administration of Substance of Abuse
Off-label Use of Drug or Device
Population
Indicate which of the following populations will be included in this research
Adults
Adults over 50
Substance Users
Research Support/Funding
Will an existing internal account be used to support the project?
No
Is the project externally funded or is external funding planned?
Yes
Select the number of external sources of funding that will be applicable to this study
Funding Source #1
Is the PI of the grant/contract the same as the PI of the IRB protocol?
Yes
Select one of the following
The grant/contract application is a pending review or a funding decision
Source of Funding
Federal
Institute/Agency
NIDA
Grant Name
Medication Development for Opioid and Alcohol Abuse: Laboratory Studies in Humans
Grant Number
DA039169
Select one of the following
Single Site
Business Office
RFMH
Does the grant/contract involve a subcontract?
Yes
Subcontracted?
To
Name institution(s)


Protocol Summary Form
7476
Comer, Sandra
Page 5 of 27
Columbia University Department of Psychiatry
Please note that as per NIDA's request, Depomed, the company that markets Gralise (sustained-release
gabapentin), has agreed to supply us with study medication and supplemental funding for advertising and to
support a research assistant.
Study Location
Indicate if the research is/will be conducted at any of the following
NYSPI
This protocol describes research conducted by the PI at other facilities/locations
No
Lay Summary of Proposed Research
Lay Summary of Proposed Research
Currently, the abuse of prescription opioid medications is a pervasive problem in the U.S. In
addition, co-abuse of opioids and alcohol represents a significant problem from the perspective of
increased toxicity and decreased success in treatment. Surprisingly few studies have examined
the effects of combined administration of opioids and alcohol in humans, and no clinical studies
have examined the reinforcing effects of this combination. The current 8-9-week inpatient study
will systematically evaluate gabapentin because it shows promise for treating both opioid and
alcohol use disorders (OUD and AUD). The guiding principle is that a medication’s effects on
positive subjective responses and reinforcing effects are the best laboratory procedures to date in
predicting its clinical efficacy. We will examine the ability of gabapentin to alter opioid-, alcohol-,
and combined opioid/alcohol-mediated responses. Participants will meet DSM-5 criteria for
moderate-severe OUD and be physically dependent on opioids. In addition, participants will meet
DSM-5 criteria for moderate-severe AUD, but they will not be physically dependent on alcohol. All
of the participants will be maintained on oral morphine throughout the study and different doses of
gabapentin will be evaluated. Overall, the proposed study will provide a great deal of information
about the safety and clinical utility of gabapentin for treating co-abuse of opioids and alcohol.
Background, Significance and Rationale
Background, Significance and Rationale
Anticonvulsant medications, such as gabapentin, pregabalin, and topiramate, have been evaluated for the
treatment of drug and alcohol dependence. Gabapentin is a particularly interesting medication because it
has a good safety and tolerability profile, minimal abuse liability, and is already in widespread clinical use
for other disorders, such as chronic pain, anxiety, and sleep disorders. Gabapentin inhibits
neurotransmitter release by blocking presynaptic voltage-gated Na+ and Ca2+ channels. Specifically, it is


Protocol Summary Form
7476
Comer, Sandra
Page 6 of 27
thought to inhibit the alpha-2-delta subunit of presynaptic Ca2+ channels, which may indirectly modulate 
gamma-aminobutyric acid (GABA) and perhaps glutamate neurotransmission (Sills, 2006). Dr. Evans, who 
is a co-Investigator on this proposal, showed that pretreatment with an acute dose of gabapentin (0, 1000, 
or 2000 mg) did not alter the subjective effects of alcohol (0.75 g/kg) or alcohol craving in heavy drinkers 
(Bisaga and Evans, 2006). However, a recent clinical trial demonstrated that maintenance on gabapentin 
(0, 900, and 1800 mg/day) produced dose-related increases in rates of complete abstinence from alcohol 
in alcohol-dependent patients, as well as improvements in mood, sleep, and craving (Mason et al., 2014). 
Other studies have shown that gabapentin is useful in treating symptoms associated with alcohol 
withdrawal (Malcolm et al., 2007; Mason et al., 2009). Few studies have examined the effects of 
gabapentin on the abuse liability of opioids, however. A study conducted in rats demonstrated that 
gabapentin prevented the development of morphine-induced CPP, and blocked morphine-induced 
dopamine release in the nucleus accumbens (Andrews et al., 2001). Although gabapentin does not appear 
to be useful for treating opioid withdrawal in clinical settings (Kheirabadi et al., 2008; Sanders et al., 2013), 
opioid-positive urine samples were significantly lower in patients who received gabapentin compared to 
placebo during outpatient detoxification from opioids (Sanders et al., 2013). Thus, these preliminary studies 
suggest that gabapentin might be useful in treating OUD, and more substantial evidence suggests that it is 
useful in treating AUD. A major goal of the present proposal is to evaluate the ability of gabapentin 
maintenance to reduce the abuse liability of alcohol, oxycodone, and alcohol in combination with 
oxycodone in participants with both OUD and AUD.
Specific Aims and Hypotheses
Specific Aims and Hypotheses
We will examine different doses of gabapentin (0 and 1800 mg) in combination with different doses of 
oxycodone, alcohol, and the oxycodone/alcohol combination in order to establish safety (e.g., respiratory 
depression), tolerability (e.g., side effects), and preliminary efficacy (e.g., subjective and reinforcing 
effects). 
HYPOTHESIS 1: Active medication will be superior to placebo medication in reducing alcohol 
and/or oxycodone-induced positive subjective and reinforcing effects.   
Two primary measures will be considered in each study: positive subjective responses, measured by visual 
analog scales and reinforcing effects measured by the crossover point on the Multiple Choice Procedure. 
These data will be analyzed using repeated-measures ANOVAs with planned contrasts with medication 
dose (2 levels) as the first factor and oxycodone and/or alcohol dose as the second factor (9 levels: 
placebo and active oxycodone in combination with placebo and active alcohol). Differences in subjective 
ratings and crossover point as a function of oxycodone and/or alcohol dose will be evaluated under each 
medication dose. We will conduct two sequences of planned comparisons: 1) effects of peak measures 
averaged across participants, and 2) time course of drug effects (all time points compared). Both sets of 
analyses will be accomplished by repeated measures ANOVA’s.
HYPOTHESIS 2: Active medication will be superior to placebo medication in reducing alcohol 
and/or oxycodone craving and physiological responses (as a measure of safety).
The secondary measures of interest for this study are for craving, specifically, ratings of “I want opioids” 
and “I want alcohol,” as well as scores on the Opioid Craving Questionnaire and Alcohol Craving Scale. 
Physiological responses, particularly as related to respiratory function (e.g., respiratory rate, arterial oxygen 


Protocol Summary Form
7476
Comer, Sandra
Page 7 of 27
saturation, end tidal carbon dioxide, heart rate, blood pressure) also will be evaluated. As above, these 
measures will be analyzed using repeated-measures ANOVAs with planned contrasts using medication 
dose (2 levels) and oxycodone and/or alcohol dose (9 levels: placebo and active oxycodone in combination 
with placebo and active alcohol) as factors. Other dependent measures (cognitive effects, sleep measures, 
number of cigarettes smoked, and other physiological effects) will be analyzed in a manner similar to the 
subjective ratings. That is, peak (or trough) and time course analyses will be conducted on these 
measures.
Description of Subject Population
Sample #1
Specify subject population
Non-treatment-seeking subjects with moderate-severe opioid and alcohol use disorder
Number of completers required to accomplish study aims
24
Projected number of subjects who will be enrolled to obtain required number of completers
36
Age range of subject population
21-59
Gender, Racial and Ethnic Breakdown
The proposed study seeks to include women and minorities; the study does not exclude any
potential participants on the basis of race or gender. Both males and females will be recruited.
Based on previous studies, it is estimated that the sample will be approximately 75% male, 55%
Caucasian, 30% Black or African-American, 15% Hispanic or Latino, 0-5% Asian and Pacific
Islander and less than 1% Native American. All efforts will be made to ensure that
representation of women and ethnic minorities are in proportion to the population of the city of
New York.
Description of subject population
Participants meeting DSM-5 criteria for moderate-severe OUD and physical dependence on opioids will be 
enrolled. Participants also will meet DSM-5 criteria for moderate-severe AUD (men and women will 
consume at least 15 and 8 alcohol drinks per week, respectively), but will not be physically dependent on 
alcohol. Participants will report simultaneous use of opioids and alcohol and will not be seeking treatment 
for OUD or AUD. None of the participants will be physically dependent on alcohol or any other drugs with 
the exception of opioids, nicotine and caffeine.
Recruitment Procedures
Describe settings where recruitment will occur
All in-person screening and assessments (drug interview, psychiatric evaluation, medical
examination, and naloxone challenge) will occur within the facilities of the Substance Use
Research Center (SURC), located on the 3rd floor of the NYSPI.


Protocol Summary Form
7476
Comer, Sandra
Page 8 of 27
How and by whom will subjects be approached and/or recruited? 
Initial telephone interviews will be carried out by research assistants and nurses; 2) drug interview 
and general assessment related to study issues will be conducted by a psychologist/psychiatric 
nurse practitioner; 3) psychiatric interviews and oral dose administrations will be conducted by a 
nurse; 4) SCIDs will be performed by a trained nurse or clinical psychologist. Telephone screens 
will be recorded either electronically or on paper forms.
How will the study be advertised/publicized? 
Recruitment is primarily through word-of-mouth and advertisements in local newspapers such 
as AM New York, as well as electronic media (e.g., RecruitMe, Facebook, Google, StudyKik, and 
websites that drug users frequent such as Bluelight and Erowid).  There will be recruitment 
through advertisements on MTA bus interiors.
Do you have ads/recruitment material requiring review at this time? 
Yes
Does this study involve a clinical trial?
Yes
Please provide the NCT Registration Number
NCT03205423
Concurrent Research Studies
Will subjects in this study participate in or be recruited from other studies? 
Yes
Describe concurrent research involvement
6723: Risks and Benefits of Overdose Education and Naloxone Prescribing to Heroin Users (PI:
Sandra Comer, Ph.D.)
Inclusion/Exclusion Criteria
Name the subject group/sub sample
Subjects with OUD and AUD
Create or insert table to describe the inclusion criteria and methods to ascertain them
1) DSM-5 criteria for moderate-severe opioid use disorder with physical dependence. Ascertained 
By: Clinical interviews (telephone, psychologist, nurse, physician), naloxone challenge test/visual 
evidence of opioid withdrawal. 
2) DSM-5 criteria for moderate-severe alcohol use disorder without physical dependence. 
Ascertained By: Clinical interviews (telephone, psychologist, nurse, physician) and visual evidence 
of alcohol withdrawal.
3) No current major mood, psychotic, or anxiety disorder. Ascertained By: Clinical
interview with physician or nurse. 


Protocol Summary Form
7476
Comer, Sandra
Page 9 of 27
4) Physically healthy. Ascertained By: Clinical interview with physician, laboratory tests (urinalysis, 
blood chemistry, 12-lead ECG), physical examination, self-reported medical history, chest x-ray or 
ppd skin test. 
5) Able to perform study procedures. Ascertained By: Practice session. 
6) 21-59 years of age. Ascertained By: Self-reported age and/or verification with legal 
identification. 
7) Normal body weight/Within 20% of body weight (for appropriate frame) according to 1983 
Metropolitan Weight tables. 
8) Current or history of illicit opioid use. Ascertained By: Clinical interviews (telephone, 
psychologist, psychiatric nurse practitioner and psychiatrist) 
9) Current use of opioids in amounts and/or frequencies that meet or exceed those used in the 
proposed study (e.g., 3-4 tablets of a Rx opioid medication per day or 1-2 bags of heroin per day). 
Not seeking treatment for opioid use disorder (neutral attitude or not wanting treatment only). 
Ascertained By: Clinical interviews (telephone, psychologist, psychiatric nurse practitioner and 
psychiatrist).
10) Participants will consume alcohol at least 3 times per week (15 drinks per week for men and 8 
drinks per week for women). In addition, they will drink alcohol and use opioids simultaneously.
Create or insert table to describe the exclusion criteria and methods to ascertain them
1) DSM-5 criteria for substance use disorder (moderate to severe) on drugs other than opioids, 
alcohol, nicotine or caffeine (must be less than 500 mg caffeine daily). Ascertained By: Clinical 
interview with psychiatrist, psychiatric nurse practitioner, urine screen, observation. 
2) Participants requesting treatment. Ascertained By: Self-report during interview. 
3) Pregnancy or lactation. Ascertained By: Blood pregnancy testing, self-report
during interview. 
4) Current or recent history of significant violent or suicidal behavior and/or suicidal/homicidal risk. 
Ascertained By: Clinical interview (based on current state and history). 
5) Cannot read or understand the self-report assessment forms unaided, or are so severely 
disabled that they cannot comply with the requirements of the study. Ascertained By: Clinical 
interview, practice session. 


Protocol Summary Form
7476
Comer, Sandra
Page 10 of 27
6) Elevated liver function tests (i.e., AST and ALT > 3 times the upper limit of normal) or impaired 
renal function (creatinine must be within normal limits). Ascertained By: Laboratory tests. 
7) Physical disorders that might make participation hazardous such as AIDS, cancer,
hypertension (blood pressure > 140/90), uncontrolled diabetes, pulmonary hypertension or heart 
disease (please note that participants will be asked about previous visits to a cardiologist, chest 
pain, or strong palpitations; if these exist, they will be referred to a cardiologist and excluded 
unless cleared for participation by a cardiologist). Ascertained By: Clinical interview, ECG. 
8) Current major Axis I psychopathology, other than OUD and AUD (e.g., mood disorder with 
functional impairment, schizophrenia), that might interfere with ability to participate in the study.
Ascertained By: Clinical interviews. 
9) Sensitivity, allergy, or contraindication to opioids, alcohol, gabapentin or similar medications. 
Ascertained By: Clinical interview. 
10) Taken an investigational drug within the past 30 days. Ascertained By: Clinical interview. 
11) Current or history of chronic pain within the past 3 months. Ascertained By: Clinical interview. 
12) Taking prescription psychotropic medications that would potentially interfere with study 
procedures. Ascertained By: Clinical interview.
Waiver of Consent/Authorization
Indicate if you are requesting any of the following consent waivers
Waiver of consent for use of records that include protected health information (a HIPAA waiver of 
Authorization) 
No
Waiver or alteration of consent
Yes
Waiver of documentation of consent 
No
Waiver of parental consent 
No
Consent Procedures
Is eligibility screening for this study conducted under a different IRB protocol?
No
Describe procedures used to obtain consent during the screening process 
Upon the participants' first visit to NYSPI, the general study procedures are described by a


Protocol Summary Form
7476
Comer, Sandra
Page 11 of 27
research assistant. If the participant is still interested in screening for the study, (s)he is given a
screening consent to review. After giving the participant time to review the screening consent
form, (s)he meets with a research nurse, psychologist or physician to sign the screening
consent to initiate screening procedures detailed in the document.
Describe Study Consent Procedures
The physician conducts the physical examination; the physician or psychiatric nurse practitioner
conducts psychiatric examination, reviews the inclusion/exclusion criteria, and obtains consent to
study participation. As a result of our ongoing consent procedures throughout screening with
various personnel, the date that the participant signs the study consent form sometimes will differ
from the date that the physician signs the study consent form.
Indicate which of the following are employed as a part of screening or main study consent procedures
Consent Form
Information Sheet
Justification for Waiver or Alteration of Consent
Waiver of consent is requested for the following
As per 45CRF46.116(d) of the Code of Federal Regulations, we are requesting a waiver of
consent for our telephone screen.
Explain why your research can not be practicably carried out without the waiver or alteration
Participants first respond to study advertisements via telephone.
Describe whether and how subjects will be provided with additional pertinent information after participation
If participants meet the initial inclusion/exclusion criteria based on the telephone interview, they
will be invited to the laboratory for in-person screening visits where the study procedures will be
explained again in detail by multiple staff members.
Persons designated to discuss and document consent
Select the names of persons designated to obtain consent/assent
Bisaga, Adam, MD
Blevins, Derek
Brezing, Christina, MD
Comer, Sandra, PHD
Evans, Suzette, PHD
Foltin, Richard, PHD
holt, ida
Iqbal, Muhammad
Jones, Jermaine, PHD
Kidd, Jeremy
Luo, Sean, MD
Manubay, Jeanne, MD
Mogali, Shanthi, MD
MURRAY, JANET


Protocol Summary Form
7476
Comer, Sandra
Page 12 of 27
Shulman, Matisyahu, MD
Srivastava, A Benjamin
Tindall, Claudia
Vorel, Stanislav, MD
Wai, Jonathan, MD
Williams, Arthur
Woolfolk, Vincent
Type in the name(s) not found in the above list
Study Procedures
Describe the procedures required for this study
The ability of gabapentin (Gralise; 0, 1800 mg/day) to alter the effects of a range of doses of 
oxycodone (0, 15, and 30mg/70kg per os (PO)) and alcohol (0, low dose, high dose PO) alone 
and in combination will be tested. Immediately after admission, participants will be stabilized on 
immediate-release oral morphine (30 mg, q.i.d. at 8am, 4pm, 8pm, and 11pm). In addition, they 
will be randomized to receive 0 mg or 1800 mg/day gabapentin once daily at 8am. When 
participants are maintained on active gabapentin, the dose will be titrated up to 1800 mg over the 
course of 1 week. Specifically, participants will receive 600 mg on Day 1, 1200 mg on Day 2, and 
1800 mg on Days 3-7. If uncomfortable side effects emerge after initiation of gabapentin 
administration, the titration schedule will be adjusted until the side effects dissipate. After the 
approximately 1-week stabilization period on the first dose of gabapentin, they will initiate a 3-
week testing period. At the end of the first 3-week testing period, participants will be transferred to 
the other dose of gabapentin using the same 1-week stabilization period and then they will again 
complete 3 weeks of testing. Participants will be tapered off of the medication on an inpatient 
basis at the end of the study.  
At each gabapentin dose administration, participants will receive 6 capsules in order to maintain 
the dosing blind. Based on our previous studies, we will test placebo, 0.50 g/kg, 0.75 g/kg alcohol 
(Evans & Levin 2003, 2004, 2011; Reed et al., 2012). Alcohol dose will be calculated based on the 
estimated total body water (TBW) of each participant to eliminate differences in alcohol 
pharmacokinetics (Watson et al., 1980), using different regression equations for males and 
females. The beverage volume will be 350 ml for females and 500 ml for males. Participants can 
select their preferred mixer from among a selection of equicaloric, non-caffeinated beverages and 
the investigators will prepare a SINGLE drink each session with 100 proof vodka added to achieve 
the correct volume for each individualized alcohol dose. Lime or peppermint drops will be added to 
the top of the beverage and food color will be mixed in to mask its flavor and color. Participants 
will consume the entire beverage within 5-7 min (5 for women, 7 for men) under staff supervision. 
The placebo beverage will consist of the mixer alone. For oxycodone/alcohol combination doses, 
oxycodone (~ 0.75 or 1.5 ml of a 20 mg/ml concentrated solution) will be added to the beverage. 
The active medication doses were chosen based on estimated effectiveness in reducing alcohol-
mediated effects and/or maximum estimated tolerability. An 1800 mg maximum daily dose of 


Protocol Summary Form
7476
Comer, Sandra
Page 13 of 27
gabapentin was chosen because it was well tolerated and effective in treating alcohol dependence 
(Mason et al., 2014). A 1-week titration/stabilization period will be used because we have found in 
previous studies that this schedule is well tolerated by both alcohol and cocaine abusers (Hart et 
al., 2007; Mariani et al., 2006). 
During test weeks, participants will receive 9 dose combinations of oxycodone (0, 15, and 30 
mg/70kg) and alcohol (0, low, and high doses). Oxycodone and alcohol will be administered at the 
same time because most abusers report simultaneous use (McCabe et al., 2006), and previous 
studies have reported that the peak effects of oxycodone and alcohol occur at similar time points 
(see Comer et al., 2010; Kirkpatrick and de Wit, 2013; Rush et al., 2001; Walsh et al., 2008). Each 
dose combination will be administered on separate days (Table 1) and the time course of acute 
effects will be assessed prior to and for 6 hours after dose administration (Table 2). The first two 
participants in each study will receive the active oxycodone and alcohol combinations (15mg/70kg 
oxycodone + low-dose alcohol; 30mg/70kg oxycodone + high-dose alcohol) in ascending order 
under each maintenance condition to ensure safety. Thereafter, if the dose combinations are 
safely tolerated, all doses will be administered in random order. Sessions will be separated by at 
least 48 hours and session events will be identical on each test day (Table 2).
During the laboratory sessions, the subjective effects battery will consist of a Drug Effects 
Questionnaire (Evans et al., 1995), Visual Analog Scales (e.g., “I feel high,” “I feel sociable”), the 
Biphasic Alcohol Effects Scale (Martin et al., 1993), an Alcohol Craving Scale (adapted from 
Tiffany and Drobes, 1991; Tiffany et al., 1993), the Opioid Symptom Checklist (Derogatis et al., 
1974; Fraser et al., 1961; Martin and Fraser, 1961), an Opioid Craving Questionnaire (adapted 
from Tiffany and Drobes, 1991; Tiffany et al., 1993) and a short form of the State-Trait Anxiety 
Inventory (Marteau and Bekker, 1992). The Subjective Opiate Withdrawal Scale (SOWS; 
Handelsman et al., 1987) and the Clinical Opiate Withdrawal Scale (COWS; Wesson and Ling, 
2003) will assess opioid withdrawal, and the revised Clinical Institute Withdrawal for Alcohol Scale 
(CIWA-Ar; Sullivan et al., 1989) will assess alcohol withdrawal.
Although our laboratory typically uses operant self-administration procedures, the Multiple Choice 
Procedure (Griffiths et al., 1993; Mumford, Evans et al., 1995) will be used in the proposed studies 
because it is an efficient method of assessing drug reinforcement. At the end of each laboratory 
session, participants will make 9 discrete drug versus money choices (dose received that day 
versus $0.25, $0.50, $1.00, $2.00, $4.00, $8.00, $16.00, $32.00, and $64.00). For each dose 
combination, the primary dependent variable in this task is the “crossover point,” which is the 
maximum dollar value at which participants choose the dose over money. Over the course of the 
study, participants will make 243 individual choices between the dose and money (9 choices per 
session x 27 sessions = 243 choices). They will be informed at the beginning of the study that one 
of their 243 choices will be reinforced randomly during a final session at the end of the study 
(physiological responses will be monitored for safety, but no data will be collected during this last 
session). 
Two cognitive tasks also will be used in the proposed study. The Digit Symbol Substitution Task 
(DSST; McLeod et al., 1982) assesses psychomotor ability and the Divided Attention Task 
assesses attention (DAT; Miller, 1987). In our experience, these tasks can sensitively detect the 


Protocol Summary Form
7476
Comer, Sandra
Page 14 of 27
effects of drugs and drug withdrawal on cognitive functioning. They can also be used to screen for 
potential adverse effects of study medications on cognition. The DSST and DAT will be completed 
before and repeatedly after drug administration. 
Breath alcohol levels will be determined before and repeatedly after each dose administration 
during laboratory sessions using breathalyzers (Alco-Sensor III, Intoximeters, Inc., St. Louis, MO). 
In addition, hart rate (HR) and blood pressure (BP) will be measured using a Criticare Poet Plus 
8100 vital signs monitor (Critical Systems, Inc., Waukesha, WI), and recorded at 10-min intervals. 
Arterial oxygen saturation, respiratory rate (RR), and end tidal CO2 also will be measured using 
the Criticare monitor. A soft sensor will be placed over the fingertip on the non-dominant hand. 
Respiration will be monitored continuously throughout the laboratory session and recorded every 
10 min. Pupil photographs will be taken before and after drug administration using a digital 
pupilometer (Neuroptics), which captures a downloadable image of the eye and reports pupil 
diameter. 
A Sleep Questionnaire will provide subjective ratings of sleep (quality, hours of sleep, etc.). In 
addition, objective sleep measures will be assessed using a wrist-worn ActiWatch Activity 
Monitoring System (Respironics Co., Bend, OR).
Adverse events, urine drug toxicologies, cognitive and physical functioning will be assessed 
repeatedly during the inpatient stay (Table 3). 
You can upload charts or diagrams if any
Criteria for Early Discontinuation  
Criteria for Early Discontinuation
Participants will be withdrawn from the study if they 1) do not comply with unit policies or study
procedures, 2) are deemed medically at risk for further study participation, or 3) express a strong 
desire to receive treatment for their drug use. Vital signs prior to oxycodone administration must 
be within acceptable ranges (%SpO2 > 92) for drug administration to occur. Careful attention will 
be paid to oxygen saturation since respiratory depression is a clear sign that no further doses 
should be administered. We will ask participants to take a deep breath if their oxygen saturation 
falls below 90%. In the unlikely event that prompted breaths do not bring the oxygen saturation 
above 90% within 3 min, we will provide supplemental oxygen through a nasal cannula. We will 
administer naloxone if the above measures are unsuccessful in restoring normal oxygen 
saturation. A participant will be withdrawn from the study if he/she experiences an overdose 
(over-intoxication requiring medical intervention: e.g. naloxone administration), develops a 
psychiatric or medical problem for which it is deemed that further study participation would 
endanger his/her health, or requests exit or referral to treatment. 


Protocol Summary Form
7476
Comer, Sandra
Page 15 of 27
All participants who are withdrawn from the study
will be offered referrals to treatment facilities and our Substance Treatment and Research Service. 
Those participants who are discontinued from study participation because of sensitivity to the 
respiratory effects of the opioids administered during the study will receive a special de-briefing by 
the study physician prior to discharge. Specifically, participants will be warned of the risks, namely 
overdose and death, associated with continued opioid use. A standard script will be reviewed with 
all subjects prior to discharge to discuss the increased risk of overdose and how the prevalence of 
fentanyl/carfentanil in street heroin compounds this risk. Buprenorphine or naltrexone will be 
offered to subjects. Buprenorphine  or naltrexone will be initiated prior to discharge for those who 
wish to initiate treatment with these medications. As part of research safety measures for 
discharge, the research volunteers are bridged with buprenorphine/naloxone films for up to 2 
weeks, if they decide to pursue buprenorphine/naloxone treatment. Staff on 5-South and in the 
Opioid Lab will facilitate engagement in a methadone program for participants who wish to be 
maintained on it.
Blood and other Biological Samples
Please create or insert a table describing the proposed collection of blood or other biological specimens
During the screening process, approximately 30 cc blood will be drawn for laboratory testing. 
Urinalysis will be performed at each screening visit, 1 random sample analyzed weekly while 
participants are inpatient and on each follow-up visit. 
Several studies have demonstrated that responses to opioids, alcohol, and medications for 
treating OUD and AUD may vary depending on genetic polymorphisms (Anton et al., 2008; 
Kranzler et al., 2013; Oslin et al., 2003). An ongoing study in our laboratory (Dr. Jermaine Jones, 
co-Investigator on the present proposal) is designed to examine the relationship between 
oxycodone-mediated effects and genetic variability. We will pool the data from the current studies 
with that database, although it is beyond the scope of the present proposal to examine the 
influence of genetic variation on our measures of interest because of our small sample sizes. A 
recent study attempting to carefully replicate previous candidate gene studies for amphetamine-
mediated effects reported that their original findings were likely false positives and the 
investigators expressed caution in conducting these types of studies (Hart et al., 2013). However, 
we will collect samples for genetic analyses (e.g., 118G, 511C (or 31T), and CYP2D6 
(*3,*4,*5,*6,*7, or *8)) to conduct exploratory analyses of the relationship between the candidate 
genes and our study endpoints. Approximately 30cc blood will be drawn for this purpose.
Phamacokinetic samples for gabapentin and morphine are drawn twice during in-patient stay; A total 
of approximately 40cc's of blood will be drawn for this purpose. 


Protocol Summary Form
7476
Comer, Sandra
Page 16 of 27
Assessment Instruments
Create a table or give a brief description of the instruments that will be used for assessment
Screening Instruments
Telephone Interview: 10 min
Drug History Questionnaire: 10 min
General Health Questionnaire: 5 min
Short Michigan Alcohol Screening Test: 5 min
Medical History Questionnaire: 10 min
Mental Status Evaluation: 10 min
Beck Depression Inventory: 15 min
Clinical/Drug History Interview: 30 min
36-Item Short Form Survey Instrument (SF-36) Health Survey: 5 min
Lifestyle Profile II: 2 min
Sleep Quality Assessment (PSQI): 5 min
Insomnia Severity Index: 2 min
Locally developed Sleep Questionnaire: 2 min
Quality of Life Enjoyment and Satisfaction Questionnaire: 5 min 
Test of Premorbid Functioning:  10 minutes.
Flanker Inhibitory Control and Attention Test: 3 minutes 
Picture Sequence Memory Test: 7 minutes
List Sorting Working Memory Test: 7 minutes 
Picture Vocabulary Test: 4 minutes
Oral Reading Recognition Test: 3 minutes
Dimensional Change Card Sort Test: 4 minutes
Pattern Comparison Processing Speed Test: 3 minutes
Auditory Verbal Learning Test (Rey):3 minutes
Oral Symbol Digit Test:  3 minutes
Physical and Psychiatric Examination including a Speech Task: 1 hr Laboratory
Hospital Tests: 2-3 hr
Subjective and Performance Tasks
Digit-Symbol Substitution Task: 3 min
Divided Attention Task: 10 min
*Several questionnaires will be used to assess subjective effects during the study. The first 
questionnaire is a 26-item visual analog scale designed to assess subjective and physiological 
effects. The first eighteen lines are labeled with adjectives describing mood states (“I feel…alert, 
anxious, a bad effect, depressed, energetic, a good effect, gooseflesh, high, irritable, mellow, 
muscle pain, nauseated, restless, sedated, sleepy, social, stimulated, talkative”) and four 
additional lines are labeled with questions about the dose just received (“The dose was potent,” 
“The dose was of high quality,” “I liked the dose,” “For this dose, I would pay…”). Participants also 
indicate, by making a mark along a 100 mm line, how much they “want” each of the following 
drugs: heroin, cocaine, alcohol, and tobacco. Participants rate each item on the visual analog 


Protocol Summary Form
7476
Comer, Sandra
Page 17 of 27
scale from “Not al all” (0 mm) to “Extremely” (100 mm), except for the “For this dose, I would pay”
question, which ranges between $0 (0 mm) and $20 (100 mm). The second questionnaire is a 13-
item opioid symptom checklist consisting of true/ false questions designed to measure opioid
effects (“I feel normal,” “My skin is itchy,” “I feel relaxed,” “I feel like I am coasting,” “I feel like I am
nodding,” “I feel high,” “I feel sleepy,” “I feel drunken,” “I feel nervous,” “I have a lot of drive,” “I feel
like I am ‘on a soapbox’ (need to talk),” “My stomach is turning,” and “I am feeling a pleasant
sick”). The visual analog scale and opioid symptom checklist together constitute the subjective-
effects battery. The third questionnaire is the 16-item Subjective Opioid Withdrawal Scales.
Participants rate each item on a scale from 0 to 4, with 0 being “Not at all” and 4 being “Extremely”
(“I feel anxious,” “I feel like yawning,” “I’m perspiring,” “My eyes are tearing,” “My nose is running,”
“I have gooseflesh,” “I am shaking,” “I have hot flashes,” “I have cold flashes,” “My bones and
muscles ache,” “I feel restless,” “I feel nauseous,” “I feel like vomiting,” “My muscles twitch,” “I
have cramps in my stomach,” “I feel like shooting up now”). The fourth questionnaire is a 6-item
Drug Effects Questionnaire. Specific items on the Drug Effects Questionnaire are: “How strong a
drug effect are you feeling right now?” “Do you feel any good effects from the drug?” “Do you feel
any bad effects from the drug?” “Which one of the drugs listed below is the drug most like?” “Rate
the degree to which you would be willing to take today’s drug again.” “Do you like the way the drug
makes you feel right now?” Participants describe drug effects by selecting among a series of
possible answers ranging from 0 (“No (good, bad, etc.) effects at all) to 4 (“Very strong effects”).
Ratings of drug type are: “Placebo (No drug), Stimulant, Sedative or Tranquilizer.” Ratings of drug
liking range between -4 (“Dislike very much”) and 4(“Like very much”). In addition to the above
items, an Opioid Craving Questionnaire (OCQ) will be administered each evening throughout the
study. Each question on the OCQ will be rated on a 7-point scale with “Strongly Disagree” at one
end and “Strongly Agree” at the other end. Total scores could range between 0 and 70. In
addition, the Biphasic Alcohol Effects Scale (Martin et al., 1993), an Alcohol Craving Scale
(adapted from Tiffany and Drobes, 1991; Tiffany et al., 1993), and a short form of the State-Trait
Anxiety Inventory (Marteau and Bekker, 1992) will be administered. A 14-item sleep questionnaire
(St. Mary’s Hospital Sleep Questionnaire) asking about the quantity and quality of the previous
night’s sleep will also be administered each evening.
Please attach copies, unless standard instruments are used
Off label and investigational use of drugs/devices
Choose from the following that will be applicable to your study
Drug
Select the number of drugs used in this study
1
Drug #1
Name of the drug
Gabapentin (Gralise)
Manufacturer and other information


Protocol Summary Form
7476
Comer, Sandra
Page 18 of 27
Depomed markets Gralise, a once a day formulation of gabapentin.
Approval Status
IND is approved
IND#
135,131
Who holds the IND/IND sponsor?
IND is held by PI/CU Investigator
Comer, Sandra, PHD
Research Related Delay to Treatment
Will research procedures result in a delay to treatment?
No
Treatment to be provided at the end of the study
During the last week of the study and/or prior to discharge, participants will receive counseling
about different treatment options. For those participants requesting outpatient treatment,
appropriate arrangements will be made during the last week, including placement in an outpatient 
treatment study at our Substance Treatment and Research Service (STARS), if they are eligible, 
or participation in group therapy or Narcotics Anonymous. As part of research safety measures for 
discharge, we will bridge participants to treatment with buprenorphine/naloxone sublingual films 
for up to 2 weeks.  If they decide to pursue treatment with buprenorphine/naloxone, they must 
come in every 3-5 days to pick up the films to bridge them.  If they do not want medication 
assisted treatment for opiate dependence with buprenorphine/naloxone, we will still provide them 
with 3-4 buprenorphine 8mg/naloxone 2mg sublingual films for harm reduction purposes.  We and 
the social workers on 5-South will make arrangements with a provider for those requesting 
medication-assisted treatment.
Clinical Treatment Alternatives
Clinical treatment alternatives
This is not a treatment study. However, counseling about different treatment options and referrals 
for treatment are available to participants at any time, before, during, or after their participation in 
this study. Participants will also be informed that they do not have to participate in this study in 
order to get a referral to help stop taking drugs.
Risks/Discomforts/Inconveniences 
Risks that could be encountered during the study period
DRUG ADMINISTRATION:


Protocol Summary Form
7476
Comer, Sandra
Page 19 of 27
The major risk of research participation is clearly related to drug administration. These risks include the 
possibilities of deleterious behavioral effects due to drug intoxication. However, we have had experience 
thus far with a number of different drugs of abuse, including alprazolam, alcohol and numerous opioids, 
including oxycodone. We have administered alcohol to approximately 230 individuals and we have 
administered oxycodone (oral or intravenous) to over 100 individuals, with no serious adverse 
consequences. Our careful procedures and monitoring will minimize any risks. We carry out follow-up 
interviews of participants at 3 months after study termination. At that time, in addition to assessing general 
health and well being, we obtain information about each participant’s level of drug use. In our experience 
over the many years that we have carried out this kind of research, participation in these studies appears to 
neither increase nor decrease drug use in the long term, and in the short term, drug use declines after 
study participation (Roux et al., 2012).
We are following the National Advisory Council on Drug Abuse Recommendations for the Administration of 
Drugs to Human Subjects and the NIAAA council guidelines for Ethyl Alcohol Administration in Human 
Experimentation. The doses of alcohol (low and high: ~0.5 and 0.75 g/kg) being administered are within the 
psychoactive range and the dose of alcohol will not exceed the equivalent of 3 drinks. Thus, the risk of drug 
toxicity appears minimal when the drugs are administered as proposed – under careful medical 
supervision. The investigators and the staff are well trained in behavioral observation, and participants will 
be monitored throughout the session, thereby allowing us to detect untoward reactions to the dosing 
regimen. In addition, vital signs will be monitored and performance tasks indicative of drug intoxication will 
be measured. Because the drugs administered are expected to produce some sedation and performance 
impairment, participants will be observed for several hours after drug/alcohol administration both in the 
laboratory and on the inpatient unit. A physician and/or a psychiatric nurse practitioner will be present in the 
laboratory during the time of expected peak drug effects.  A physician will be on call in the event of an 
emergency. A physician* and/or a psychiatric nurse practitioner will be present for long enough after dose 
administration to ensure stability of vital signs. [*The attending study physicians who cover the majority of 
our laboratory sessions are Drs. Manubay and Mogali (both have been working in our lab for several 
years). C. Tindall, NP has been working in our lab for 10 years as an research nurse].
Oxycodone.  The most frequently reported adverse experiences associated with oxycodone administration 
are: lightheadedness, dizziness, sedation, nausea, and vomiting. Hypotension, respiratory depression, 
mood changes (euphoria, dysphoria), constipation, skin rash, dry mouth, headache, sweating, weakness, 
seizures, and pruritis have also been reported.  More rarely, arrhythmias, bradycardia, and tremors have 
been reported. 
Alcohol.  The most common side effects of alcohol include: dizziness, faintness, irritability, confusion, 
drowsiness, sleepiness, sleep disturbance, lightheadedness, loss of coordination and clumsiness, gait 
disturbance, lack of concentration, tremor, restlessness, gastrointestinal upset, vomiting, headache, pallor, 
flushing, sweating, dry mouth, slurred speech and fatigue. Rare side effects that could be more serious 
include: depression, itching, fever, palpitation (heart pounding), arrhythmia (irregular heart beats), nausea, 
increased or decreased blood pressure, blurred vision, rash, or possibly an allergic reaction. 
Gabapentin. Common side effects include dizziness, drowsiness, loss of balance, confusion, headache, 
nausea, vomiting, dry mouth, blurred vision, cold or flu-like symptoms, loss of balance, trembling, skin rash, 
loss of appetite, stomach pain, weight gain, breast swelling, changes in urination, rapid back and forth 
movement of eyes, and peripheral edema. Antacids containing aluminum or magnesium may interfere with 
the absorption of this medication. Hydrocodone (Lortab, Vicodin, and others), morphine (Kadian, MS 
Contin, and others), and naproxen can interact with this medication by worsening dizziness, drowsiness 
and confusion. Rare side effects that could be more serious are weight gain, chest pain, irregular heart 


Protocol Summary Form
7476
Comer, Sandra
Page 20 of 27
rhythm, shortness of breath, delusions, increased risk of suicidal thinking and behavior, increased risk of 
seizures if discontinued abruptly, easy bruising or bleeding, or possibly an allergic reaction. Drug Reaction 
with Eosinophilia and Systemic Symptoms (DRESS) has also been associated with antiepileptic drugs, 
including gabapentin. Participants will be stabilized on gabapentin over a period of approximately 1 week. 
We have used similar titration periods safely in several previous studies (Hart et al., 2004, 2007; Mariani et 
al., 2006). Participants maintained on active gabapentin at the end of the study will be tapered off of the 
medication over a period of approximately 1 week. 
INCREASED SENSITIVITY TO PRESCRIPTION OPIOIDS:
Participants who were dependent on opioids upon admission to the hospital may be less tolerant to the 
effects of opioids at discharge. They will be counseled about the risks of decreased tolerance prior to 
discharge and made aware that they may be more sensitive to the effects of opioids upon completion of 
the study. They will be told that this increased sensitivity to opioids could result in overdose and death, 
and that extreme caution must be exercised after they leave the hospital, if they choose to use any 
opioid again.
NALOXONE CHALLENGE TEST:
To determine whether or not participants are dependent on opioids prior to admission into the hospital, we 
will administer up to 0.8 mg naloxone intramuscularly (by injection) which may produce a number of 
withdrawal symptoms. Participants may experience certain effects such as: sweating, restlessness, 
stomach pain, diarrhea, headache, anxiety, nausea, vomiting, dizziness, runny nose, yawning, muscle 
aches, or tremors. We will monitor their reactions to naloxone for up to 45 min. At the end of this period, we 
may prescribe oral morphine to alleviate those symptoms. 
STABILIZATION ON MORPHINE:
Participants may experience withdrawal discomfort during the stabilization period during the first few 
days after admission into the hospital including sweating, restlessness, stomach pain, headache, 
anxiety, nausea, vomiting, dizziness, runny nose, yawning, muscle aches, or tremors. If participants 
experience these symptoms, we will prescribe medications such as clonidine, clonazepam, ketorolac 
tromethamine, ondansetron, and ibuprofen or acetaminophen to alleviate those symptoms. 
Benzodiazepines will only be administered in relatively low, oral doses so the risks of adverse reactions 
due to the combination of opioids and benzodiazepines will be low. Clonidine and other comfort 
medications will only be used during the initial stabilization phase and will be discontinued prior to the 
laboratory sessions.
PREGNANCY: 
Female participants must not be pregnant to be included in the study. Pregnancy tests will be performed 
during screening and every other week during study participation. 
BLOOD DRAWING:
During the screening assessments, approximately 30 cc venous blood will be collected for medical 
evaluation. In addition, approximately 70 cc venous blood will be collected for genetic testing (DNA will be 
extracted and stored in our freezer) and measurements of plasma levels of morphine and gabapentin. 
Blood drawing may cause slight discomfort at site of needle entry and result in a small bruise.


Protocol Summary Form
7476
Comer, Sandra
Page 21 of 27
CONFIDENTIALITY: 
Potential participants divulge information that is sensitive and may have adverse social consequences if 
released. This would include information released to insurance companies, health care agencies, family 
members, or made public in any way. A Certificate of Confidentiality has been obtained for the current 
study and procedures for protecting confidentiality of records will be followed. Specifically, all data records 
containing identifying information will be kept in locked files and on password-protected computers. Blood 
samples for genetic testing will be sent only with participant code numbers, with no potentially identifying 
information. Only the study investigators will have access to the codes linking the participant to his or her 
identifying information. The agencies performing these genetic tests will not have access to the subjects’ 
identifying information. Only the primary investigator and other core study staff will have access to 
identifiable information, which will be maintained on site under lock and key. All computer data is stored 
without names or other identifiable information. Participants will be identified only through a numerical code 
in all electronic databases. 
Describe procedures for minimizing risks
  Opioid Administration: Medications will be administered by medical staff trained in the use of opioids, and 
in the management of respiratory effects of opioids. Emergency doses of an opioid antagonist(naloxone), 
resuscitative and intubation equipment, and oxygen will be readily available. During experimental sessions, 
oxygen saturation and vital signs will be continuously monitored, and the participant will be observed for 
early signs of hypotension, apnea, upper airway obstruction and oxygen de-saturation. 
Criteria for Withholding Drug: Vital signs prior to oxycodone administration must be within acceptable 
ranges (%SpO2 > 92) for drug administration to occur. Careful attention will be paid to oxygen saturation 
since respiratory depression is a clear sign that no further doses should be administered. We will ask 
participants to take a deep breath if their oxygen saturation falls below 90%. In the unlikely event that 
prompted breaths do not bring the oxygen saturation above 90% within 3 min, we will provide supplemental 
oxygen through a nasal cannula. We will administer naloxone if the above measures are unsuccessful in 
restoring normal oxygen saturation. We have safely tested a bolus dose of 50 mg intravenous oxycodone 
in a previous study, so we do not anticipate problems with the doses of oxycodone proposed here (Comer 
et al., 2008). 
Sensitivity to Opioids: Participants will be counseled about the risks of decreased tolerance to opioids prior 
to discharge, and made aware that they may be more sensitive to the effects of opioids upon completion of 
the study. They will be told that this increased sensitivity to opiates could result in overdose and death, and 
that extreme caution must be exercised after they leave the hospital, if they choose to use any opioid 
again. 
Study Drug: Participants will be informed about the possible side effects of gabapentin and will be told to 
notify a nurse or physician if begin to experience any of them. If present, medical staff will note which 
symptoms are present, their severity, and make a decision whether to continue the participants in
the study. 
Naloxone Challenge: We will monitor their participants' reactions to naloxone for up to 50 min. At the
end of this period, we may prescribe oral morphine or an intramuscular injection of morphine to
alleviate those symptoms. 


Protocol Summary Form
7476
Comer, Sandra
Page 22 of 27
Stabilization: If participants experience withdrawal symptoms, we will prescribe drugs such as clonidine, 
clonazepam, ketorolac tromethamine, ondansetron, and ibuprofen or acetaminophen to alleviate those
symptoms. Trazodone or zolpidem will be available on some evenings at bedtime throughout the study to 
help alleviate the insomnia that participants may experience. 
Inpatient Facilities: We describe the isolation, boredom and inactivity at length prior to signing the consent 
form. Of course, participants are free to leave the study at any time.  However, participants are advised to 
avoid evening, night, and weekend discharge so that measures to prevent opioid overdose can be 
instituted. 
Additional Procedures to Minimize Risk:
a) Participants are fully informed of the potential side effects of the drugs and the risks of the
procedures. Participants are monitored by trained medical staff during experimental sessions.
Emergency medical equipment is available in our laboratory and, as well, we are located in a
hospital where a full medical emergency back-up team is constantly available. In addition, we
have developed guidelines for opioid administration such that oxygen saturation dictates whether
supplemental oxygen will be administered. Naloxone is available during all laboratory sessions in
the event of serious respiratory depression. b) An extensive battery of screening tests, including
psychometric evaluations, interview assessments, and a medical examination in order to provide
as much information as possible upon which to base participant selection. c) The maintenance of
continuous visual observation and communication with participants throughout experimental
sessions in order to provide adequate information about methods and procedures, as well as to
immediately detect any adverse participant reactions. d) Strict adherence to the agreement with
participants to permit withdrawal from participation in the research at any time in order to minimize
any adverse participant reactions. e) The location of the laboratory within the Psychiatric Institute
complex to assure the continuous availability of an on-call psychiatry resident in order to provide
medical treatment as needed. All participants are fully informed of the various side effects that
they might experience, and since all have had extensive drug histories, these should be familiar to
them. Participants are monitored 24 hr/day. Emergency medical equipment is available in our
laboratory and, as well, we are located in a hospital where a full medical emergency back-up team
is constantly available. We anticipate, however, that careful participant selection, dose selection,
and participant monitoring will eliminate the need for such emergency care.
During the last week of the study and/or prior to discharge, participants will receive counseling about 
different treatment options. For those participants requesting treatment, appropriate arrangements will be 
made including placement with a buprenorphine provider, enrollment in an outpatient treatment study at 
our Substance Treatment and Research Service (STARS), if they are eligible, or enrollment in a 
therapeutic community. Our research staff, as well as social workers on the inpatient unit, facilitate 
activation of Medicaid and treatment engagement prior to discharge. Initiation of buprenorphine or 
naltrexone administration will be provided on the inpatient unit. We will provide up to 2 weeks of 
buprenorphine/naloxone sublingual films to bridge those participants who desire treatment and need time 
to enter a facility.  They will be expected to come here every 3-5 days to pick up the amount of films 
needed to bridge them to treatment.  If buprenorphine maintenance is not desired, we will provide them 
with 3-4 sublingual films with instructions upon discharge for harm reduction purposes. Follow up treatment 
is also available to all participants who request it. We will provide a naloxone kit and training to all 
participants prior to discharge from the inpatient unit on how to recognize the symptoms of opioid overdose 
and how to respond to it. We will also counsel them about the risks of overdose at each visit during 


Protocol Summary Form
7476
Comer, Sandra
Page 23 of 27
screening and at each visit when they pick up their study payments. During the screening and study 
payment visits, we will perform urine drug screens, including screening for fentanyl use. We will discuss the 
results of the urine drug tests with all participants and warn them about the particular risks associated with 
the use of fentanyl. 
Methods to Protect Confidentiality
Describe methods to protect confidentiality
We deal with issues of confidentiality by using coded records, store signed consent forms in a
locked safe, and try to the best of our ability to maintain confidentiality. Electronic data are stored
on computers that are password protected. We have obtained a Certificate of Confidentiality for 
this study. We also point out to prospective participants that we cannot assure that their drug 
histories and other personal records might not become known. Those who are hospitalized have 
hospital charts and we cannot guarantee the confidentiality of these charts.
Will the study be conducted under a certificate of confidentiality?
Yes, we have already received a Certificate of Confidentiality
Direct Benefits to Subjects  
Direct Benefits to Subjects
This study was not designed to benefit subjects directly.
Compensation and/or Reimbursement 
Will compensation or reimbursement for expenses be offered to subjects?
Yes
Please describe and indicate total amount and schedule of payment(s). 
Include justification for compensation amounts and indicate if there are bonus payments.
Participants are compensated for each visit of the screening process ($25/visit). We 
anticipate that screening will necessitate 3-4 visits. Participants will also be paid $25 for a 
follow-up visit approximately 4 weeks after study completion.
Participants will be paid $50/day with a $50/day bonus for completion of the study. Use of a per 
diem bonus is necessary to keep participants from leaving the study during the last several days 
when the money remaining to be earned would otherwise be proportionately small. Payments will 
be in cash, separated into several installments ($600 per week) at the end of the study in order to 


Protocol Summary Form
7476
Comer, Sandra
Page 24 of 27
prevent large one-time payments. Total payments will be approximately $5700. It is not possible to 
determine a priori the exact number of study days (e.g., accounting for holidays, admission date, 
staff schedules, etc.) and the consent form does not specify a number. 
Assuming that the participant agrees to continue in the protocol, s/he will be paid according to the 
same schedule described above.
References
References
Andrews N, Loomis S, Blake R, Ferrigan L, Singh L, McKnight AT (2001) Effect of gabapentin-like 
compounds on development and maintenance of morphine-induced conditioned place preference. 
Psychopharmacology (Berl) 157(4): 381-7.
Bisaga A, Evans SM (2006) The acute effects of gabapentin in combination with alcohol in heavy drinkers. 
Drug Alcohol Depend 83: 25-32.
Comer SD, Sullivan MA, Vosburg SK, Manubay J, Amass L, Cooper ZD, Saccone P, Kleber HD (2010) 
Abuse liability of intravenous buprenorphine/naloxone and buprenorphine alone in buprenorphine-
maintained intravenous heroin abusers. Addiction 105(4): 709-18. 
Derogatis LR, Lipman RS, Rickels K, et al (1974) The Hopkins Symptom Checklist (HSCL): a self-report 
symptom inventory. Behav Sci 19: 1–15. 
Evans SM, Foltin RW, Levin FR, Fischman MW (1995) Behavioral and subjective effects of DN-2327 
(pazinaclone) and alprazolam in normal volunteers. Behav Pharmacol 6(2): 176-186.
Fraser HF, van Horn GD, Martin WR, Wolbach AB, Isbell H (1961) Methods for evaluating addiction 
liability. (A) “Attitude” of opioid addicts toward opioid-like drugs, (B) A short-term “direct” addiction test. J 
Pharmacol Exp Ther 133: 371-387.
Griffiths RR, Troisi II JR, Silverman K, Mumford GK (1993). Multiple-choice procedure: an efficient 
approach for investigating drug reinforcement in humans. Behav Pharmacol 4, 3-13.
Handelsman L, Cochrane KJ, Aronson MJ, Ness R, Rubinstein KJ, Kanof PD (1987) Two new rating scales 
for opioid withdrawal. Am J Drug Alcohol Abuse 13(3): 293-308.
Hart CL, Haney M, Vosburg SK, Rubin E, Foltin RW (2007) Gabapentin does not reduce smoked cocaine 
self-administration: employment of a novel self-administration procedure. Behav Pharmacol 18(1): 71-5.
Kheirabadi GR, Ranjkesh M, Maracy MR, Salehi M (2008) Effect of add-on gabapentin on opioid 
withdrawal symptoms in opium-dependent patients. Addiction 103(9): 1495-9. 


Protocol Summary Form
7476
Comer, Sandra
Page 25 of 27
Kirkpatrick MG, de Wit H (2013) In the company of others: social factors alter acute alcohol effects. 
Psychopharmacology (Berl) 230(2): 215-26.
Malcolm R, Myrick LH, Veatch LM, Boyle E, Randall PK (2007) Self-reported sleep, sleepiness, and 
repeated alcohol withdrawals: a randomized, double blind, controlled comparison of lorazepam vs 
gabapentin. J Clin Sleep Med 3(1): 24-32.
Manchikanti L, Helm S 2nd, Fellows B, Janata JW, Pampati V, Grider JS, Boswell MV (2012) Opioid 
epidemic 
Mariani JJ, Rosenthal RN, Tross S, Singh P, Anand OP (2006) A randomized, open-label, controlled trial of 
gabapentin and phenobarbital in the treatment of alcohol withdrawal. Am J Addict 15(1): 76-84.
Martin CS, Earleywine M, Musty RE, Perrine MW, Swift RM (1993) Development and validation of the 
Biphasic Alcohol Effects Scale. Alcohol Clin Exp Res 17(1): 140-6.
Martin WR, Fraser HF (1961) A comparative study of physiological and subjective effects of heroin and 
morphine administered intravenously in postaddicts. J Pharmacol Exp Ther 133: 388-399.
Marteau TM, Bekker H (1992) The development of a six-item short-form of the state scale of the 
Spielberger State-Trait Anxiety Inventory (STAI) Brit J Clin Psychol 31: 301-306.
Mason BJ, Light JM, Williams LD, Drobes DJ (2009) Proof-of-concept human laboratory study for 
protracted abstinence in alcohol dependence: effects of gabapentin. Addict Biol 14(1): 73-83. 
Mason BJ, Quello S, Goodell V, Shadan F, Kyle M, Begovic A (2014) Gabapentin treatment for alcohol 
dependence: a randomized clinical trial. JAMA Intern Med 174(1): 70-7.
McCabe SE, Cranford JA, Morales M, Young A (2006) Simultaneous and concurrent polydrug use of 
alcohol and prescription drugs: Prevalence, correlates, and consequences. J Stud Alcohol 67: 529-537.
McKee SA, Harrison EL, O'Malley SS, Krishnan-Sarin S, Shi J, Tetrault JM, Picciotto MR, Petrakis IL, 
Estevez N, Balchunas E (2009) Varenicline reduces alcohol self-administration in heavy-drinking smokers. 
Biol Psychiatry 66(2):185-90. 
McKee SA, O'Malley SS, Shi J, Mase T, Krishnan-Sarin S (2008) Effect of transdermal nicotine 
replacement on alcohol responses and alcohol self-administration. Psychopharmacology (Berl) 196(2):189-
200. 
McLeod DR, Griffiths RR, Bigelow GE, Yingling J (1982) An automated version of the Digit Symbol 
Substitution Test (DSST). Behav Res Meth Instr Comp 14: 462-466.
Miller J (1987) Evidence of preliminary response preparation from a divided attention task. J Exp Psychol 
Hum Percept Perform 13(3): 425-34.


Protocol Summary Form
7476
Comer, Sandra
Page 26 of 27
Mumford GK, Evans SM, Fleishaker JC, Griffiths RR (1995) Alprazolam absorption kinetics affects abuse 
liability. Clin Pharmacol Ther 57: 356-365.
Rush CR (2001) Pretreatment with hydromorphone, a 
 agonist, does not alter the acute behavioral 
and physiological effects of ethanol in humans. Alcoholism: Clin Exp Res 25(1): 9-17.
Sanders NC, Mancino MJ, Gentry WB, Guise JB, Bickel WK, Thostenson J, Oliveto AH (2013) 
Randomized, placebo-controlled pilot trial of gabapentin during an outpatient, buprenorphine-assisted 
detoxification procedure. Exp Clin Psychopharmacol 21(4):294-302. 
Sills GJ (2006) The mechanisms of action of gabapentin and pregabalin. Curr Opin Pharmacol 6(1): 108-
13. 
Smith RJ, & Aston-Jones G (2012) Orexin/hypocretin 1 receptor antagonist reduces heroin self-
administration 
Sullivan JT, Sykora K, Schneiderman J, Naranjo CA, Sellers EM (1989) Assessment of alcohol withdrawal: 
The revised Clinical Institute Withdrawal Assessment for Alcohol scale (CIWA-Ar). British Journal of 
Addiction 84: 1353-1357.
Sullivan MA, Vosburg SK, & Comer SD (2006) Depot naltrexone: antagonism of the reinforcing, subjective, 
and physiological effects of heroin. Psychopharmacology (Berl) 189(1): 37-46.
Szabo G, Kovacs GL, Telegdy G (1987) Effects of neurohypophyseal peptide hormones on alcohol 
dependence and withdrawal. Alcohol Alcoholism 22(1): 71-74.
Tiffany ST, Drobes DJ (1991) The development and initial validation of a questionnaire on smoking urges. 
Br J Addict 86(11): 1467-76.
Tiffany ST, Singleton E, Haertzen CA, & Henningfield JE (1993) The development of a cocaine craving 
questionnaire. Drug Alcohol Depend 34(1): 19-28.
Walsh SL, Nuzzo PA, Lofwall MR, & Holtman JR Jr (2008) The relative abuse liability of oral oxycodone, 
hydrocodone and hydromorphone assessed in prescription opioid abusers. Drug Alcohol Depend 98(3): 
191-202.
Wesson DR, & Ling W (2003) The Clinical Opiate Withdrawal Scale (COWS). J Psychoactive Drugs 35(2): 
253-9. 
Uploads
Upload the entire grant application(s)
Upload copy(ies) of unbolded Consent Form(s)
Upload copy(ies) of bolded Consent Form(s)
Upload copy(ies) of unbolded Information Sheet(s)
Upload copy(ies) of bolded Information Sheet(s)


Protocol Summary Form
7476
Comer, Sandra
Page 27 of 27
Upload copy(ies) of recruitment materials/ads to be reviewed
Upload evidence of FDA IND approval(s)
Upload a copy of Certificate of Confidentiality
Upload copy(ies) of the HIPAA form
hipaa op:alc feb 2019.pdf
Upload any additional documents that may be related to this study


Form #PP2: HIPAA Authorization for Research .
.1  
New York State Psychiatric Institute (NYSPI)
Authorization to Use or Disclose Health Information during a Research Study
Protocol Number:
Principal Investigator:
Name of Study:
Before researchers can use or share any identifiable health information (“Health Information”) about you as part of the 
above study (the “Research”), the New York State Psychiatric Institute (NYSPI) is required to obtain your authorization. You agree 
to allow the following individuals and entities to use and disclose Health Information about you as described below: 
New York State Psychiatric Institute (NYSPI), your doctors and other health care providers, if any, and
The Principal Investigator and his/her staff (together “Researchers”).   Researchers may include staff of NYSPI, the New York
State Office of Mental Health (OMH), Research Foundation for Mental Hygiene, Inc. (RFMH), and Columbia University (CU),
provided such staff is a part of the study, and
Central Reference Laboratories 
KI), i  indicated in the consent form.
1.
The Health Information that may be used and
 disclosed for this Research includes:
All information collected during the Research as told to you in the Informed Consent Form.  
Health Information in your clinical research record which includes the results of physical exams, medical and 
psychiatric history, laboratory or diagnostic tests, or Health Information relating to a particular condition that is related  to 
the Research.
Additional information may include: 
2.
The Health Information listed above may be disclosed to:
Researchers and their staff at the following organizations involved with this Research: 
The Sponsor of the Research, 
and its agents and contractors (together, “Sponsor”); and  
Representatives of regulatory and government agencies, institutional review boards, representatives of the Researchers 
and their institutions to the level needed to carry out their responsibilities related to the conduct of the research.   
Private laboratories and other persons and organizations that analyze your health information in connection with 
this study 
Other (family members or significant others, study buddies, outside agencies etc.) Specify: 
3.
By giving permission to release your Health Information as described above, you understand that your Health
Information may be disclosed to individuals or entities which are not required to comply with the federal and state privacy laws
which govern the use and disclosure of personal Health Information by NYSPI.   This means that once your Health


Form #PP2: HIPAA Authorization for Research . .1  
Information has been disclosed to a third party which does not have to follow these laws (e.g., a drug company or the Sponsor 
of the Research), it may no longer be protected under the HIPAA or NYS Mental Hygiene Law requirements but is subject to the 
terms of the consent form and may be subject to other state or federal privacy laws or regulations.  
4.
Please note that:
You do not have to sign this Authorization form, but if you do not, you
 not be able to participate in the study or
receive study related care.  You may change your mind at any time and for any reason. If you do so, you may no
longer be allowed to participate in the study.  If you withdraw this Authorization the research staff and the Sponsor, if this
is sponsored research, may still use or disclose Health Information containing identifying information they already have
collected about you as needed to maintain the reliability of the research.  Any request to withdraw this Authorization
must be made in writing to (enter name and contact information below):
While the Research is going on, you may not be allowed to review the Health Information in your clinical research
record that has been created or collected by NYSPI.   When this research has been completed you may be allowed to see
this information.  If it is needed for your care, your Health Information will be given to you or your Doctor.
5.
This Authorization does not have an end date.
6.
You will be given a copy of this form after you have signed it.
I agree to the use and disclosure of Health Information about me as described above: 
__________________________________________                _____________________ 
Signature of Par
/ Legal Representative    
Date 
______________________________________ 
Printed Name of Par
 
______________________________________ 
 
We also ask you or your legal representative to initial the statements below: 
I have received a copy of the NYSPI/OMH Notice of Privacy Practices. 


Statistical Analyses 
 
In order to control for Type-1 error and to be consistent with the 2017 FDA Assessment 
of Abuse Potential of Drugs Guidance for Industry, drug liking was considered the 
primary abuse liability endpoint. VAS data were analyzed using repeated-measures 
ANOVAs with planned contrasts with medication dose (2 levels) as the first factor, OXY 
dose as the second factor (3 levels), ALC dose as the third factor (3 levels), and time as 
the fourth factor (16 levels). Two repeated-measures ANOVAs were conducted: 1) mean 
time course of drug effects across the test session, and 2) mean peak ratings. P values less 
than 0.05 were considered statistically significant, consistent with the 2017 FDA 
Assessment of Abuse Potential of Drugs Guidance for Industry. 


Information and Consent Form 
Sandra D. Comer, Ph.D., Study PI 
NYSPI IRB#7476 
Initials __________    Date __________ 
Version 4, Dated March 2020 
Page 1 of 9 
Informed Consent for Participation in Research 
Study Title: 
Medication Development for Opioid and Alcohol Abuse: 
Laboratory Study in Humans 
Study #: 
NYSPI IRB#7476 
Principal Investigator:  
Sandra D. Comer, Ph.D. 
Study Doctor: 
Jeanne M. Manubay, M.D.  
 
Study Center Address:   
New York State Psychiatric Institute  
1051 Riverside Drive, Unit 120 
       
New York, NY 10032 
 
24-Hour Emergency Contact: 
Dr. Sandra Comer  
 
646-774-6146  
 
Mr. Vincent Woolfolk  
917-873-4331 
You should keep a copy of this form. If you have any questions or problems during the study, 
call the phone number(s) above. 
The study doctor wants to know if you would like to be part of a research study.   
If you have any questions about the study or do not understand something in this form, you 
should ask the study doctor or study staff. You should also discuss your participation with 
anyone you choose in order to better understand this study and your options.   
Participating in a research study is not the same as getting regular medical care. The 
purpose of regular medical care is to improve your health. The purpose of a research study is 
to gather information.   
 


Information and Consent Form 
Sandra D. Comer, Ph.D., Study PI 
NYSPI IRB#7476 
Initials __________    Date __________ 
Version 4, Dated March 2020 
Page 2 of 9 
Study Purpose and Overview 
Summary: This page is a summary of the study in which you are being asked to participate. 
This outline is meant to be a guide for you to use while considering the study and reading the 
consent form. It is not meant to replace the consent form you will be asked to sign if you 
decide to participate in the study. The consent form contains much more detailed information 
about the study and the risks that you will be asked to consider in making your decision. 
• 
The main purpose of this research study is to gather information on how safe and 
effective a medication called gabapentin is for the treatment of opioid and alcohol use 
disorder. Gabapentin (Gralise®) is a medication given orally (by mouth) and is currently 
approved by the U.S. Food and Drug Administration for the treatment of pain from 
nerve damage. You are confirming that you drink alcohol at least 3 times per week and 
you are physically dependent on heroin or prescription opioids. Also, you are confirming 
that you are not seeking treatment for your substance use. This study is funded by the 
National Institute on Drug Abuse and Depomed, the company that markets gabapentin.    
• 
Throughout the study (about 8 weeks) you will live on 5-South, a locked 
inpatient psychiatric unit. After stabilization on morphine given by mouth 
(orally) and the study medication (gabapentin), you will begin testing.  
• 
You will receive a drink (beverage) containing either: active oxycodone, active 
alcohol, a combination of active oxycodone plus active alcohol, or “placebo,” a 
beverage containing neither oxycodone nor alcohol.  
• 
Throughout the study there will be 18 lab sessions where the drink is 
administered. These sessions are about 6.5 hours long and include: 
behavioral testing (answering questionnaires) and physiological testing 
(measurements of heart rate and breathing).  
• 
Counseling about different treatment options and referrals for treatment are 
available at any time, before, during, or after your participation in this study. 
You will be asked about your interest in treatment twice during the study, once 
near the beginning and once near the end of your stay.  
Risks: There are several risks and discomforts associated with participation in this study. 
Please read the risks section of the consent form for more details and explanations of these 
risks. Common side effects of gabapentin include dizziness, drowsiness, loss of balance, 
confusion, headache, nausea, vomiting, dry mouth, blurred vision, cold or flu-like symptoms, 
loss of balance, trembling, skin rash, loss of appetite, stomach pain, weight gain, breast 
swelling, changes in urination, rapid back and forth movement of the eyes, and swelling in 
the hands and feet. In addition, a rare but serious adverse event has been reported in 
association with gabapentin called Drug Reaction with Eosinophilia and Systemic Symptoms 
(DRESS), also known as Multiorgan Hypersensitivity. Some of these events have been fatal 
or life-threatening, and include symptoms such as fever, rash, abnormal lymph nodes, and 
sometimes looks like an acute viral infection. Alcohol can make you feel dizzy, faint, 
confused, drowsy, and nauseated. The most serious side effects of opioids include: slowed 
breathing, periods where breathing stops, or death.  
This is a voluntary research study and you do not have to participate if you do not want to. 
This research is not meant to benefit you directly.  Please contact Dr. Sandra Comer, who is 
in charge of the study, with any questions at (646) 774-6146. 


Information and Consent Form 
Sandra D. Comer, Ph.D., Study PI 
NYSPI IRB#7476 
Initials __________    Date __________ 
Version 4, Dated March 2020 
Page 3 of 9 
PURPOSE OF THIS STUDY 
The main purpose of this study is to gather information on how safe and effective a 
medication called gabapentin is for the treatment of opioid and alcohol use disorder. 
Gabapentin (Gralise®), which will be used in the current study, is a medication given orally 
(by mouth) and is approved by the U.S. Food and Drug Administration for the treatment of 
pain from nerve damage. Another formulation of gabapentin (Neurontin®) is approved for 
treating both nerve damage pain and seizure disorders. You are confirming that you drink 
alcohol at least 3 days a week (15 drinks per week for men and 8 drinks per week for 
women), and that you are physically dependent on heroin or prescription opioids. In addition, 
you are confirming that you are not dependent on any other drug with the exception of 
opioids, nicotine, and/or caffeine, and you are not currently seeking treatment for your drug 
use. The National Institute on Drug Abuse and Depomed, the company that markets 
gabapentin, are funding this study. 
The study will examine how gabapentin may affect your response to oxycodone, alcohol, and 
the combination. It is planned that about 24 people with a diagnosis of opioid and alcohol use 
disorder will complete this study.   
 
VOLUNTARY 
Participation in this research study is voluntary. If you decide not to participate, or if you later 
decide to stop participating, you will not lose any benefits to which you are otherwise entitled. 
A decision not to participate or withdraw your participation will not affect your current or 
future treatment at the New York State Psychiatric Institute or Columbia University Medical 
Center.   
ALTERNATIVES TO STUDY PARTICIPATION 
This is not a treatment study. Data are being collected for research purposes. Counseling 
about different treatment options and referrals for treatment are available at any time before, 
during, or after your participation in this study. You do not have to participate in this study in 
order to get a referral to help stop taking drugs. If you are interested in treatment, an 
appropriate outpatient treatment will be arranged. Available treatments for opioid use 
disorder include methadone and naltrexone maintenance. Maintenance on buprenorphine 
and the buprenorphine/naloxone combination also are available. Available treatments for 
alcohol use disorder are naltrexone, disulfiram and acamprosate. We will talk to you about 
your interest in treatment at least twice during the study, once near the beginning and once 
near the end of your stay. If you are interested in treatment with a medication for your opioid 
and alcohol use disorder, we can start giving you the medication before you leave the 
hospital. If you are interested in treatment with methadone, we will arrange for you to begin 
treatment after you leave the hospital. We will also ask you if a friend or family member 
would be interested in helping you with your treatment. 
STUDY PROCEDURES 
You have been chosen as a potential participant in a research study. You have signed the 
screening consent form, and passed the medical and psychiatric screening. If you are a 
woman, you have been given a pregnancy test at screening and you will be given another 
when you move into the hospital. If you are pregnant or breastfeeding, or if you have had an 
abortion within the past six months, you will not be able to participate. If you think you might 
be pregnant, please tell the investigator. Also, since pregnant women may not participate in 


Information and Consent Form 
Sandra D. Comer, Ph.D., Study PI 
NYSPI IRB#7476 
Initials __________    Date __________ 
Version 4, Dated March 2020 
Page 4 of 9 
this research, women must practice an effective method of birth control until the end of the 
study.  
Practice Session: If you agree to participate, you will have a practice session before and/or 
after you move into the hospital to show you what happens during the laboratory sessions.  
Naloxone Challenge Test: You may be given up to 0.8 mg naloxone, a drug used to reverse 
the effects of opioids, which will put you into a state of withdrawal. If you prefer not to receive 
naloxone, you can come to the laboratory at some point during the screening process to 
show us clear symptoms of opioid withdrawal. We will tell you if you can participate in the 
study when all screening procedures are completed.  
General Information About 5-South: While enrolled in the study, you will live on 5-South, a 
locked inpatient psychiatric unit, for about 8 weeks, during which visitors are not allowed. At 
times when you are not required to fill out questionnaires or do tasks, you can read or do 
puzzles, as long as these activities do not interfere with the research study protocol. You are 
free to do other activities on 5-South, which has a game room and television room. You also 
can use the telephone, books and other reading materials on 5-South. However, you agree 
not to leave the unit except with staff members for any reason during the study period. Staff 
will be available to escort you outside the unit for “fresh air” breaks up to four times per day 
along with gym visits up to three times per week (for those who are physically healthy). You 
will be given 3 meals per day, along with a bedtime snack.  
Stabilization Periods: During the first several days after admission, you will be stabilized on 
the first dose of gabapentin (active or placebo), given orally once a day, and oral morphine, 
given 4 times a day. During the stabilization period, you may experience opioid withdrawal 
symptoms. Therefore, extra medications will be available to you during this period to reduce 
any withdrawal symptoms that you may experience. About halfway through the study, you 
will be stabilized on the second dose of gabapentin (active or placebo).  
Laboratory Sessions: Laboratory sessions will take place on the 3rd floor of the New York 
State Psychiatric Institute, and each will last at least 6.5 hours. You will either receive a drink 
containing either active oxycodone, active alcohol, active oxycodone plus active alcohol, or 
placebo (no oxycodone or alcohol) for 3 days in a week (Monday, Wednesday, and Friday) 
for 3 weeks in a row. You sometimes may be asked to take a deep breath if your breathing 
slows down. Laboratory sessions will include behavioral and physiological testing. You will 
be asked to answer questions on the computer, and we will measure your heart rate and 
breathing. After stabilization on the second dose of gabapentin, you will complete another 3 
weeks of testing that will be identical to the first 3 test weeks. At the end of each of the two 
stabilization periods, approximately 2 tablespoons of blood will be collected (one sample in 
the morning and another in the afternoon) for drug level tests. 
Debriefing Session: At the end of the study, we will have a debriefing session with you to 
answer any questions that you may have. In addition, we would like to meet with you one 
month after you leave the hospital for a follow-up study visit.  During this visit, we will collect 
blood samples, questionnaires will be given and an electrocardiogram (ECG) will be done.   
Genetic Information: As a part of this study, DNA samples are collected using 2 tablespoons 
of your blood. The purpose of this part of the research study is to look at differences in 
people’s DNA in an attempt to try to understand differences in how people respond to drugs. 
At the end of this form you are able to decide how your genetic sample is used (check one). 
For the current study, samples will only be kept for a maximum of 5 years and you can tell us 
to remove and destroy the samples at any time during or after the study. However, if you 
provide consent for your DNA to be used by other researchers, once these samples are out 


Information and Consent Form 
Sandra D. Comer, Ph.D., Study PI 
NYSPI IRB#7476 
Initials __________    Date __________ 
Version 4, Dated March 2020 
Page 5 of 9 
of our hands, you will no longer be able to withdraw consent for their use. Because these 
samples will have been completely de-identified, there will be no way to trace your sample 
back to you. In some cases, whole blood samples can be used to make a cell line (cells from 
participants’ blood will be cultured and kept alive to further study the DNA). The purpose of 
establishing a cell line is to create a source of DNA for storage in a repository for future 
research. Once created, cell lines can be used indefinitely. 
RISKS AND INCONVENIENCES 
Oxycodone. The most frequently reported adverse experiences associated with oxycodone 
administration are: lightheadedness, dizziness, sedation, nausea, and vomiting. Decreased 
blood pressure, slowed breathing, mood changes (euphoria, dysphoria), constipation, skin 
rash, dry mouth, headache, sweating, weakness, seizures, and itchiness have also been 
reported. More rarely, irregular heartbeats, slowed heartbeats, and tremors have been 
reported. 
Alcohol.  The most common side effects of alcohol include: dizziness, faintness, irritability, 
confusion, drowsiness, sleepiness, sleep disturbance, lightheadedness, clumsiness, loss of 
balance, inability to concentrate, tremor, restlessness, stomach upset, vomiting, headache, 
pale skin, flushing, sweating, dry mouth, slurred speech and tiredness. Rare side effects that 
could be more serious include: depression, itching, fever, heart pounding, irregular heart 
beats, nausea, increased or decreased blood pressure, blurred vision, rash, or possibly an 
allergic reaction.  
Gabapentin. Common side effects include dizziness, drowsiness, confusion, headache, 
nausea, vomiting, dry mouth, blurred vision, cold or flu-like symptoms, loss of balance, 
trembling, skin rash, loss of appetite, stomach pain, weight gain, breast swelling, changes in 
urination, rapid back and forth movement of eyes, and swelling in the hands and feet. 
Antacids containing aluminum or magnesium may interfere with the absorption of this 
medication. Morphine can interact with this medication by worsening dizziness, drowsiness 
and confusion. Rare side effects that could be more serious are weight gain, chest pain, 
irregular heart rhythm, shortness of breath, delusions, increased risk of suicidal thinking and 
behavior, increased risk of seizures if discontinued suddenly, easy bruising or bleeding, or 
possibly an allergic reaction. In addition, a rare but serious adverse event has been reported 
in association with gabapentin called Drug Reaction with Eosinophilia and Systemic 
Symptoms (DRESS), also known as Multiorgan Hypersensitivity. Some of these events have 
been fatal or life-threatening, and include symptoms such as fever, rash, abnormal lymph 
nodes, and sometimes looks like an acute viral infection. You will be stabilized on gabapentin 
over a period of about 1 week during the study while you are living in the hospital.  You will 
be tapered off the study medication before discharge.  
Oral Morphine During Stabilization. During stabilization on oral morphine, you are likely to 
experience opioid withdrawal symptoms such as anxiety, sweating, nausea, vomiting, 
diarrhea, stomach upset, changes in blood pressure, weakness, restlessness, feelings of 
changes in temperature, sneezing, runny nose, watery eyes, gooseflesh, and insomnia. In 
order to help with these symptoms, you will receive supplemental medications for treating the 
various symptoms of withdrawal: hydroxyzine or clonazepam for anxiety/restlessness, 
bismuth subsalicylate (Pepto Bismol®) for diarrhea, clonidine for yawning, runny nose and 
eyes, sweating, and temperature changes, zolpidem (Ambien®) for insomnia, acetaminophen 
or ibuprofen for muscle pain and discomfort, simethicone for nausea and stomach upset, and 
promethazine for vomiting or severe nausea.  
Increased Sensitivity to Opioids:  As a result of study participation, it is possible that you will 
be less tolerant to the effects of opioids at discharge.  You will be counseled about the risks 


Information and Consent Form 
Sandra D. Comer, Ph.D., Study PI 
NYSPI IRB#7476 
Initials __________    Date __________ 
Version 4, Dated March 2020 
Page 6 of 9 
of decreased tolerance to opioids. You should be aware that you may be more sensitive to 
the effects of heroin or other opioids upon completion of this study. This increased sensitivity 
to opiates could result in overdose and death.  Thus, doses of heroin or other opiates that 
you used to take before entering the hospital could be enough to cause you to stop breathing 
and die. It is for this reason that an evening, night or weekend discharge from the hospital is 
discouraged. Fentanyl and carfentanil are powerful synthetic opioids that can be added to 
heroin without your knowledge and these further increase your risk of overdose. Extreme 
caution must be exercised after you leave the hospital, if you choose to use any opioid again.   
Naloxone Challenge Test. To determine whether or not you are dependent on opioids, we 
may administer up to 0.8 mg naloxone by injection into your arm muscle, which may produce 
a number of unpleasant withdrawal symptoms. You may experience certain effects such as: 
sweating, restlessness, stomach pain, diarrhea, headache, anxiety, nausea, vomiting, 
dizziness, runny nose, yawning, muscle aches, or tremors. We will monitor your reactions to 
naloxone for up to 45 min. At the end of this period, we may prescribe oral morphine or an 
intramuscular injection of morphine to alleviate those symptoms. The doses of morphine 
have been carefully selected to be below dangerous levels, but you should be aware that you 
may experience side effects which may include: drowsiness, itchiness, dry mouth, sweating, 
restlessness, constipation, headache, anxiety, slowed breathing, nausea, vomiting, 
dizziness, sedation, or tremors. 
Blood Drawing. During blood drawing, there is a risk of slight discomfort and/or bruising at 
the site where the needle is inserted. Approximately 100 ml (about half a cup) will be taken 
during the study. When someone donates blood, two cups (32 tablespoons) are taken on 
one occasion. 
Inpatient Facility. The risks involved in exposure to the inpatient unit and laboratory are 
minimal, but you may become bored or restless. Additionally, cigarette smoking on 5-South 
is not allowed. Electronic cigarettes can be purchased and used at certain times, and 
nicotine gum or patch will be prescribed on the unit.  
BENEFITS 
This study is not designed to benefit you personally. 
CONFIDENTIALITY 
We will do everything we can to keep others from learning about your participation in the 
research. The information you give us for this study is covered by a Confidentiality Certificate 
from the National Institutes of Health (NIDA). With this Certificate, the investigators cannot be 
forced (for example, by court subpoena) to disclose or use information, documents, or 
biospecimens that may identify you in any federal, state, or local civil, criminal, 
administrative, legislative, or other action, suit, or proceeding, or be used as evidence, for 
example, if there is a court subpoena, unless you have consented for this use.  Information, 
documents, or biospecimens protected by this Certificate cannot be disclosed to anyone else 
who is not connected with the research except, if there is a federal, state, or local law that 
requires disclosure, such as to report suspected or known neglect or sexual or physical 
abuse of a child, or threatened violence to self or others, or contagious diseases; if you have 
consented to the disclosure, including for medical treatment; or if it is used for other scientific 
research, as allowed by federal regulations protecting research subjects. Such information 
will be reported to the appropriate authorities. If we learn about serious harm to you or 
someone else, we will take steps to protect the person or persons endangered even if it 
requires telling the authorities without your permission. However, we will only disclose 


Information and Consent Form 
Sandra D. Comer, Ph.D., Study PI 
NYSPI IRB#7476 
Initials __________    Date __________ 
Version 4, Dated March 2020 
Page 7 of 9 
information to the extent necessary to prevent harm to the person or persons believed to be 
endangered 
The Certificate cannot be used to refuse a request for information from personnel of the 
United States federal or state government agency sponsoring the project or from Institutional 
regulatory personnel that is needed for auditing or program evaluation by NIDA which is 
funding this project or for information that must be disclosed in order to meet the 
requirements of the federal Food and Drug Administration (FDA). A Certificate of 
Confidentiality does not prevent you or a member of your family from voluntarily releasing 
information about yourself or your involvement in this research. Note however, that if an 
insurer, employer or other outside party, learns of your participation, and obtains your 
consent to receive research information, then the investigator may not use the Certificate of 
Confidentiality to withhold this information. This means that you and your family must also 
actively protect your own privacy. 
Records will be available to research staff, and to Federal, State and Institutional regulatory 
personnel (who may review records as part of routine audits). Signed consent forms and 
other forms containing identifying information will be kept in a locked file, and all interviews, 
assessments, etc. will be coded with initials and numbers. Your name and other personal 
identifying information will be stored in an electronically secure database at New York State 
Psychiatric Institute. Electronic data are also coded and are stored on computers that are 
password protected.   
If you want your research information released to an insurer, medical care provider, or any 
other person not connected with the research, you must provide consent to all researchers to 
release it. Your private information will only be used for this particular study. Your biological 
specimens, if collected, may or may not be used by other researchers or for future studies, 
as indicated by your choices at the end of this consent. 
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. 
All records containing links and identifying information related to your genetic information will 
be kept in locked files and on password-protected computers. This information will only be 
available to NYSPI personnel key to this investigation. Your blood sample will be labeled with 
a code that will be used throughout screening and testing. The sample will not have your 
name, or address on it. The laboratories carrying out the DNA analysis (Columbia University, 
Human Genetics Resources Core, 630 W. 168th St. New York, NY 10032) and LGC 
Genomics (100 Cumming Center, Beverly, MA 01915) will never know your identity. If you 
also agree to have your DNA stored for future research, this number will be removed from 
your sample so there will be no way to know that it came from you, and it will not be possible 
to trace your identity.  
The Genetic Information Nondiscrimination Act (GINA) provides additional protections for you 
against discrimination based upon your private genetic information. This Federal law 
generally makes it illegal for health insurance companies, group health plans, and most 
employers to discriminate against you based on your genetic information. GINA does not 
protect you against genetic discrimination by companies that sell life insurance, disability 
insurance, or long-term care insurance or by adoption agencies. GINA also does not protect 
you against discrimination based on an already diagnosed genetic condition or disease. If 
you would like to know more about it you can discuss this with the principal investigator of 
this study (Dr. Comer, 646 774-6146) or you can go to the following website 
http://www.genome.gov/10002328. 


Information and Consent Form 
Sandra D. Comer, Ph.D., Study PI 
NYSPI IRB#7476 
Initials __________    Date __________ 
Version 4, Dated March 2020 
Page 8 of 9 
COMPENSATION 
As a result of participating in this research, you will receive $25 for each laboratory screening 
visit, to a maximum of three visits, and $25 for the naloxone challenge test/visual inspection 
of withdrawal symptoms prior to being accepted into the study. This money will be paid at the 
end of each day. You will also receive $50/inpatient day, plus a bonus of $50/inpatient day 
for completion of the study, and $25 for a follow-up study visit about 4 weeks after you leave 
the hospital. Total payments will be between approximately $5,700, depending on the 
number of days it takes you to complete the study.   
Payments will not exceed $600 per week. You will return on a weekly basis for your 
payments until you have received all of the money you earned while participating in the 
study. Failure to comply with the protocol could result in a deduction from your pay or 
dismissal from the study. If you withdraw early, you will not receive any of the bonus 
payment; you will only be paid $50 for each day that you completed.  
We are required by law to report your earnings to the IRS. Therefore, your Social Security 
Number and amount earned will be reported, and you will receive the appropriate IRS form at 
the end of the year in which you have been paid.  Please be aware that research 
participation may affect your eligibility to get or to keep entitlements such as Medicaid and 
other city and state support services.  No information about which study you participated in 
will be provided to the IRS.   
Research Standards and Participants' Rights 
Participation in this project is voluntary, and you may refuse to participate or discontinue 
participation at any time without loss of benefits to which you are otherwise entitled.  You will 
be notified of significant new findings that may impact your safety and that may relate to your 
willingness to participate. By signing this consent form, you are indicating willingness to join 
the research project described to you on this form.   
In Case of Injury 
Federal regulations require that we inform participants about our institution's policy with 
regard to compensation and payment for treatment of research-related injuries. In case of 
injury, New York State Psychiatric Institute will provide short term emergency medical 
treatment, which has been determined to be necessary by New York State Psychiatric 
Institute's doctors, and which is within the capability of New York State Psychiatric Institute to 
provide.  In addition, we will provide assistance in arranging follow up care in such instances. 
New York State Psychiatric Institute and Research Foundation for Mental Hygiene do not 
provide compensation or payment for treatment of research related injuries.  However, you 
should be aware that you do not give up your legal right to seek such compensation through 
the court by participating in this research.  
Please be aware that: 
1. The New York State Psychiatric Institute, Columbia University and New York Presbyterian 
Hospital will furnish that emergency medical care determined to be necessary by the medical 
staff of this hospital  
2. You will be responsible for the cost of such care, either personally or through your medical 
insurance or other form of medical coverage.  
3. No monetary compensation for wages lost as a result of injury will be paid to you by 
Research Foundation for Mental Hygiene, the New York State Psychiatric Institute, Columbia 
University and New York Presbyterian Hospital.  


Information and Consent Form 
Sandra D. Comer, Ph.D., Study PI 
NYSPI IRB#7476 
Initials __________    Date __________ 
Version 4, Dated March 2020 
Page 9 of 9 
4. By signing this consent form, you are not waiving any of your legal rights to seek 
compensation through the courts.  
Questions 
The investigators will answer to the best of his/her ability any questions that you may have 
now or in the future about the research procedures, or about your response to the 
procedures. You may contact the Principal Investigator, Dr. Sandra Comer, who can be 
reached at (646) 774-6146, if you have any questions.  If you have any questions about your 
rights as a research participant, want to provide feedback, or have a complaint, you may call 
the NYSPI Institutional Review Board (IRB). (An IRB is a committee that protects the rights of 
participants in research studies). You may call the IRB Office at (646) 774-7155 during 
regular office hours.  
CONSENT 
Dr. Comer may □, may not □ use my genetic sample for the current study. 
Dr. Comer may □, may not □ use my genetic sample for future related studies of drug 
abuse. 
Dr. Comer may □, may not □ use my genetic sample to create cell lines from my DNA for 
storage at a national repository. Once the trial ends, I will not be able to request the 
destruction of the sample because the link of my DNA sample to my identity will have been 
removed. 
I have read this form, and I have been able to ask questions about this study.  The study 
doctor or study staff has talked with me about this study.  They have answered all my 
questions.  I voluntarily agree to participate in the research study described above.  By 
signing this form, I do not give up any of my legal rights.  I will be given a copy of this consent 
form.  
 
 
 
 
 
 
 
 
 
 
Printed Name of Participant 
 
 _______________________________________________ 
__________________ 
Signature of Participant 
 
 
 
 
 
Date 
 
I have discussed the proposed research with this participant including the risks, benefits, and 
alternatives to participation (including the alternative of not participating in the research).  
The participant has had an opportunity to ask questions and in my opinion, is capable of 
freely consenting to participate in this research. 
  
 
 
Printed Name of Physician/Nurse Practitioner Explaining Consent  
 
 
 
 
 
Signature of Physician/Nurse Practitioner Explaining Consent 
Date