Digital Therapeutic Development of Virtual Cognitive-Affective Training for Opioid Use Disorder
Phase: NA
Conditions: Opioid-use Disorder
Sponsor: University of Utah

1 of 26 
7/14/2023, 3:02 PM 
1. Study Introduction 
1. 
a. Position of the Investigator:
◆Faculty or Non-Academic Equivalent
Student 
 Staff 
  Resident/Fellow 
 Other 
2. Contact Persons for the Responsible Investigator: 
3. Guests of the Responsible Investigator: 
Last Name
There are no items to display 
First Name
E-Mail 
4. What type of application is being submitted?
New Study Application (or Amendment/Continuing Review)
5. Title Of Study:
Digital Therapeutic Development of Virtual Cognitive-Affective Training for Opioid
Use Disorder 
6. Study Purposes and Objectives:
The US is experiencing an opioid crisis, with an estimated 2.5 million Americans meeting full criteria for opioid use disorder (OUD)1 and
another 10.3 million who misuse prescription opioids (i.e., have subthreshold OUD).1 In 2017, more than 70,000 people died from drug
STUDY PROTOCOL AND STATISTICAL ANALYSIS PLAN 
IRB_00141495 
2/27/2021 11:56 
AM 
Print 
Close 
1. Contacts and Title
PI: Eric Garland PhD/Associate Professor 
and Associate Director of Integrative 
Medicine 
Submitted: 
3/9/2021 
Title: Digital Therapeutic Development of Virtual Cognitive- 
Affective Training for Opioid 
Use Disorder 
Name 
Email
Training 

2 of 26 
7/14/2023, 3:02 PM 
 
 
 
overdoses in the US, approximately 70% of which involved opioids.1 Medication for opioid use disorder (MOUD) is currently the most 
effective intervention for OUD; MOUD such as buprenorphine are currently being delivered in tandem with adjunctive behavioral 
therapies in opioid treatment programs (OTPs) throughout the country. 
 
In spite of the proven efficacy of MOUD, 42% of people who begin an MOUD discontinue them within 24 weeks2 and 50% of people 
retained in MOUD have an opioid relapse within six months.3 As such, novel and efficacious behavioral adjuncts to MOUD are needed to 
improve adherence to medication, improve treatment outcomes, and reduce relapse in individuals seeking treatment for OUD. The NIH 
HEAL initiative has focused attention on behavioral research to improve medication-based treatment of OUD. Among behavioral 
interventions being considered, mindfulness-based interventions (MBIs) have been highlighted by NIH to have particular promise as 
adjunctive treatments for OUD. However, MBIs and other extant behavioral treatments for OUD require significant face-to-face contact 
and human resources—barriers to treatment accessibility that also increase the risk of treatment dropout. Therefore, novel treatment 
strategies are needed to help overcome this crisis. One strategy would include treating OUD with digital health technology in order to 
improve treatment retention and outcomes. Thus, our overall goal is to develop and pilot test a new digital therapeutic strategy based on 
an Mindfulness Oriented Recovery Enhancement (MORE), an empirically-supported MBI for OUD. Specific aims for this project are: 
 
Aim 1: To determine the detailed functional, technical, and customization requirements to translate the MORE program into a virtual 
experience, and to adapt therapeutic material from the published MORE treatment manual66 so that it can be delivered via a virtual 
reality (VR) platform. This program will be referred to as MORE-VR. 
 
Aim 2: The MORE-VR prototype will be developed from the program designed in Aim 1. Initial testing of the prototype will be conducted 
by patients to evaluate safety, usability, and satisfaction– as well as changes in proximal outcomes (opioid craving, positive affect).  
 
 
 
 
 
 
 
7. Is this a multi-site study, where more than one site needs IRB approval? 
 Yes 
 No 
 
8. Background and Introduction: 
MOUD treatment outcomes may be subverted by the allostatic effects of opioids on brain stress and reward circuitry. Allostatic models 
posit that prolonged use of opioids to alleviate affective distress may shift hedonic set points in corticostriatal brain circuitry mediating 
reward and disrupt emotion regulatory capacity, compelling opioid use as a means of preserving a dwindling sense of well-being. Thus, 
OUD involves a process of hedonic homeostatic dysregulation, in which the motivation to obtain natural rewards is re-organized around 
seeking drug-associated reward and the desire to alleviate aversive states (e.g., affective distress).4 Consequently, opioid-related cues 
come to usurp the salience of cues predicting natural, non-drug rewards, evident by heighted opioid cue-reactivity in corticostriatal 
circuitry including orbitofrontal (OFC) and anterior cingulate cortex (ACC); and the ventral striatum (VS)5–7 - propelling opioid craving 
and relapse.8,9 Unfortunately, among people treated with MOUD, blunted reactivity to non-drug rewards has been observed in brain 
regions including the dorsolateral prefrontal cortex (PFC)10 and ventral striatum11 – suggesting that reward deficits remain untreated by 
the most effective first-line medications for OUD. Further, a recent review found that there are no efficacious pharmacotherapies for 
treating opioid-related reward deficits.12 As such, to improve outcomes among people with OUD, novel interventions are needed to 
remediate hedonic dysregulation in brain reward circuitry. 
 
To that end, Mindfulness-Oriented Recovery Enhancement (MORE), a cognitive training intervention generated by a NIDA-funded 
treatment development process (R03→R34→R01), has shown significant promise. Rooted in affective neuroscience, MORE unites training 
in mindfulness, reappraisal, and savoring skills to remediate dysregulation in brain reward systems underpinning opioid misuse and OUD. 
In one Stage 1 (N=30)13 and two Stage 2 RCTs (N=11514 and N=9515), as well as in a newly completed R01-funded Stage 2/3 RCT 
(N=260), MORE significantly decreased opioid misuse and opioid craving by modulating opioid cue-reactivity and amplifying natural 
reward processing in the brain16 , demonstrating the efficacy of the face-to-face intervention for OUD. Yet, the MORE intervention, which 
must be delivered by trained clinicians, requires significant human interaction and is therefore resource intensive. Further, in light of the 
COVID-19 pandemic, people with OUD may be reticent to engage in face-to-face interventions due to the risk of viral spread. 
 
Virtual reality (VR) can overcome these implementation barriers. VR environments help serve to reduce the logistical, social, and 
psychological barriers to MBIs and traditional learning environments (e.g., traveling to a specific place, feeling self-conscious while 
practicing mindfulness, or stigma associated with the intervention). Also, VR avatars will provide a supportive learning community for 
self-guided learners who need structure when establishing a new routine such as regular mindfulness practice. An additional benefit of 
VR is that it is more scalable and disseminable compared with human teachers and usual “brick and mortar” learning environments. 
Given recent technological advances and associated decrease in cost of VR hardware, VR may be readily accessed in a variety of 
environments. The ability for a user to access VR-driven digital therapeutics in a clinic and then to have continuity of that intervention in 
the home environment may facilitate repetition of skill practice, consolidating learning and potentially boosting therapeutic 
neuroplasticity.17,18 
In that regard, the premise of this application is that delivering MORE via virtual reality  (MORE-VR) will provide an efficacious and highly 
disseminable form of this evidence-based intervention to improve MOUD outcomes. In addition to overcoming implementation barriers, 
VR tcan aid in mindfulness-based cognitive and affective training by removing sensory distractions that may otherwise hinder the learning 
process, personalizing patient experience with machine learning and biometric feedback, and encouraging interaction and imagination    
in an immersive virtual environment.19,20 Through these features, VR will increase the perceived usability of the intervention,21     
helping to bridge the gap between in-person and digital learning environments and increasing treatment engagement.22,23 

3 of 26 
7/14/2023, 3:02 PM 
 
 
 
IRB_00141495 
Created: 
2/27/2021 
11:56 AM 
IRB_00141495 
2. Study Location and Sponsors 
 
PI: Eric Garland PhD/Associate 
Professor and Associate Director of 
Integrative Medicine 
 
Submitted: 
3/9/2021 
 
 
Title: Digital Therapeutic Development of Virtual 
Cognitive-Affective Training for Opioid 
Use Disorder 
 
2. Study Location and Sponsors 
 
1. Add all locations applying for approval of research via the University of Utah IRB or Human Research 
Protection Program (HRPP). 
 
Click the appropriate button(s) below to add locations: 
 
Site Name 
Investigators Name 
Covered Entity 
Sub Sites 
 
View   University of Utah 
Eric Garland 
No 
Yes 
 
2. Will a Central IRB (CIRB) or Single IRB (SIRB) model be used for review of this study for the sites listed in 
this application? 
 Yes 
 No 
 
3. Indicate the source(s) of funding obtained or applied for to support this study. 
Sponsor Sponsor 
Type 
Sponsor Contact 
Information 
Prime Sponsor 
Prime Sponsor 
Type 
OrgID 
 
View   BEHAVR Industry 
NIH NATIONAL INSTITUTE ON 
DRUG ABUSE 
Federal 
Government 
00018365 
 
4. Does this study have functions assigned to a Contract Research Organization (CRO)? 
 Yes 
 No 
 
5. Does this study involve use of the Utah Resource for Genetic and Epidemiologic Research (RGE)? 
Examples: Utah Population Database (UPDB), Utah Cancer Registry (UCR), All Payers Claims Database (APCD), 
etc. 
 Yes 
 No 

4 of 26 
7/14/2023, 3:02 PM 
 
 
 
IRB_00141495 
Created: 
2/27/2021 11:56 
AM 
IRB_00141495 
View/Edit 
 
PI: Eric Garland PhD/Associate Professor and 
Associate Director of Integrative Medicine 
 
Submitted: 
3/9/2021 
 
 
Title: Digital Therapeutic Development of Virtual Cognitive-Affective 
Training for Opioid 
Use Disorder 
 
Addition of a Site 
 
1. Site Name: 
University of Utah 
 
2. Site Principal Investigator 
 Mark if Same as Responsible Investigator (syncs with investigator on 
the first page) 
Eric Garland 
Email 
Training 
CoI Date 
eric.garland@socwk.utah.edu  9/20/2021 
MCG 
 
12/29/2022 
 
a. Position of the Site Principal Investigator 
Faculty or Non-Academic Equivalent 
 
b. Will the Site PI consent participants? 
 Yes 
 No 
 
3. Site Contact Persons, if different from the Site PI: 
 Mark if Same as Contacts for Responsible Investigator (syncs with 
contacts on the first page) 
Name 
Email 
Training 
 
Julia Mills 
julia.mills@utah.edu 
9/14/2021 MCG  
4. Site Staff and Sub-Investigators 
 
Name 
Email 
Training 
Obtaining 
Consent 
 
 
CoI Date 
 
 

5 of 26 
7/14/2023, 3:02 PM 
 
 
 
 
Name 
Email 
Training 
Obtaining 
Consent 
 
CoI Date 
 
 
 
5. Site Guests: 
Name 
Email 
Training 
There are no items to display 
 
6. Select HIPAA coverage for this study: 
Study procedures will be conducted within a HIPAA Covered Entity at this site 
(HIPAA Privacy Rule applies) 
Study procedures will be conducted outside a HIPAA Covered Entity at this 
site (HIPAA Privacy Rule does not apply) 
 
7. Select the study procedures that will be conducted at this site:  
 
Recruitment 
Consent/Enrollment 
Research observation/intervention with participants 
Data collection 
Data analysis 
Do you have an enrollment goal or anticipated enrollment number 
for this site? 
 
◆ Yes 
 No 
Enrollment Number: 
30 

6 of 26 
7/14/2023, 3:02 PM 
 
 
 
 
8. Select the University of Utah department responsible for this research: 
COLLEGE OF SOCIAL WORK-DEAN 
9. Add any additional sites that are part of this performance group 
There are no items to display 

7 of 26 
7/14/2023, 3:02 PM 
 
 
 
IRB_00141495 
Created: 
2/27/2021 11:56 
AM 
IRB_00141495 
IRB Smart Form 
 
PI: Eric Garland PhD/Associate Professor and 
Associate Director of Integrative Medicine 
 
Submitted: 
3/9/2021 
 
 
Title: Digital Therapeutic Development of Virtual Cognitive-Affective 
Training for Opioid 
Use Disorder 
 
 
 
Sponsor Information 
a. Are you receiving award or contract management for the
sponsored funds through the University of Utah Office of
Sponsored Projects? 
◆ Yes 
 No 
If yes, select the associated OSP Proposal ID/DSS through eAward to link it to the 
ERICA system. 
You must have a fully approved Proposal ID/DSS number through eProposal which will show up 
in eAward after OSP has integrated the ID. To access the eAward application, use the 
instructions on the OSP website. 
Link to a Proposal ID/DSS through eAward 
Proposal ID/DSS: 10058817 
PI: GARLAND,ERIC L 
Sponsor: BEHAVR 
Prime Sponsor: NIH NATIONAL INSTITUTE ON DRUG ABUSE 
Department: 
Short Title: BEHAVR R43/R44 SUBAWARD 
Sponsor Award Number: 10058817 
Type: Industry 
Award Start Date: 5/15/2021 
Award End Date: 4/30/2022 
Prime Sponsor Type: Federal Government 

8 of 26 
7/14/2023, 3:02 PM 
 
 
 
IRB_00141495 
Created: 
2/27/2021 11:56 
AM 
IRB_00141495 
3. Participants 
 
PI: Eric Garland PhD/Associate Professor and 
Associate Director of Integrative Medicine 
 
Submitted: 
3/9/2021 
 
 
Title: Digital Therapeutic Development of Virtual Cognitive-Affective 
Training for Opioid 
Use Disorder 
 
 
 
1.  Ages of Participants:  
 
18 and older 
(Consent form needed) 
5.  Characteristics of Participants/Inclusion Criteria: 
Inclusion criteria: 1) Men/women 18+ years of age, 2) current DSM-5 Opioid Use Disorder diagnosis as assessed with the Mini-International 
Neuropsychiatric Interview (MINI), and 3) in treatment for opioid use disorder. 
7.  Is a substantial percentage of the participant population anticipated to be non-English 
speaking? 
 Yes 
 No 
3.  Participants 
2. Specific age range of participants (e.g., 7-12 years old, 60+, etc.): 
18+ 
3. Indicate any vulnerable participant groups (other than children) included: 
None 
If "Other", please specify: 
If "None" and no children are involved, answer the following question. 
Has the participant selection process overprotected potential subjects who are considered 
vulnerable so that they are denied opportunities to participate in research? 
 Yes 
 No 
4. Number of participants to be included and/or enrolled in this entire study, across all study locations:30 enrolled; 
1000 screened 
6. Participant Exclusion Criteria: 
1) Mindfulness intervention experience, 2) active psychosis or suicidality on the MINI); 3) reports, or is noted by clinical or study staff as 
showing cognitive impairment; 4) unwilling or unable to remain in OUD treatment for the duration of the trial (e.g., planned relocation, 
pending incarceration, etc.). 

9 of 26 
7/14/2023, 3:02 PM 
 
 
 
IRB_00141495 
Created: 
2/27/2021 11:56 
AM 
IRB_00141495 
4. Study Information 
 
PI: Eric Garland PhD/Associate Professor 
and Associate Director of Integrative 
Medicine 
 
Submitted: 
3/9/2021 
 
 
Title: Digital Therapeutic Development of Virtual Cognitive- 
Affective Training for Opioid 
Use Disorder 
 
 
4. Study Information 
 
1. Design of Study (select all that apply): 
 
  Non-Experimental and/or Descriptive Research Design: 
 
There are no items to display 
 
  Experimental and/or Interventional Research Design: 
 
Prospective Biomedical Intervention or Experiment 
 
 
 Development of a research resource (repositories, databases, etc.) 
 
There are no items to display 
 
 Other 
 
2. Does your study involve the use of any placebo? 
 Yes 
 No 
 
3. Length of entire study, from initiation through closeout: 
15 months 
 
4. How will participants be recruited or identified for inclusion in the study? 
a. Select all methods that will be used:  
 
In-person contact (e.g., patients, students, etc.) 
Referrals 
Written or electronic record review 
 
Written advertising (flyers, brochures, website postings, newspaper ads, etc.) 
 
 
b. Describe the recruitment/participant identification process in detail (e.g. who will review charts or 
records, who can refer participants to the study, where will flyers be posted, how often will recruitment 
letters be sent, when will follow-up phone calls be made, etc.): 
Recruitment efforts will be focused on reaching potential participants at the University of Utah health care system, and Highland 
Ridge Hospital, a substance use outpatient treatment program serving ~360 unique OUD patients a year. We will also recruit 
participants from other OUD treatment programs in the Salt Lake Valley. Participants may be referred to the study from a 
healthcare provider, or may self-refer after reviewing study marketing materials.  We will work closely with provider partners 
within the University of Utah, from Highland Ridge Hospital, and other OUD treatment providers to educate staff regarding the 
study, establish referral processes, and provide marketing materials. 
 
In addition to marketing within the healthcare environment, advertisements, marketing materials, and website links may be 
displayed at community locations or posted on media platforms of interest to the general community. Marketing materials include 
those attached in the documents and attachments section of this application. 
 
Provider Referrals 

10 of 26 
7/14/2023, 3:02 PM 
 
 
 
A provider may choose to refer a potentially eligible participant directly or provide marketing materials for self-referral.  If a 
provider gives a referral to the study team directly, he or she will be trained to ask permission from the patient for the study 
coordinator/assistant to contact them prior to sending contact information to the study team. 
 
We will also use the Enterprise Data Warehouse (EDW) at the University of Utah to identify potentially eligible participants through 
an initial search and will receive updated information on an ongoing basis. We will also use the Human Subjects Recruitment Tool 
to identify potentially eligible participants. Participants identified by the EDW or Human Subjects Recruitment Tool will first be sent 
an introductory letter via MyChart prior to being contacted by a member of the study team inviting them into the study. 
 
Self-Referral 
 
Potential participants will have multiple avenues for self-referral after learning about the study. 
 
▪ Call a research coordinator/assistant 
 
▪ Email a general inbox to reach a research coordinator/assistant 
 
▪ Click a link to our website: www.socialwork.edu/painstudy 
 
▪ Scan a QR code with their smartphone camera 
▪ This option connects the participant with a pre-screening survey that allows them to gain more 
information about the study and answer a few short questions to determine eligibility, and then leave 
their contact information for study personnel. 
 
 
Medical Record Review: For patients within the University of Utah covered entity, the research team has access to medical records 
and may conduct a chart review once notified of a potentially eligible participant through any of the above methods. Patient name, 
MRN, date of birth, phone number, address, and email will be recorded for the purpose of recruitment. 
 
Use of the Human Subjects Recruitment Tool (HSRT): The Principal Investigator or his study staff may utilize the HSRT to review 
the electronic health records at the University of Utah clinics to determine if potentially eligible patients are attending scheduled 
appointments. If so, the PI, coordinator, or research assistant may attempt to meet the patient at the clinic at the time of their 
appointment to inform them about the study, pre-screen for eligibility, and schedule a full study informed consent appointment. 
 
No information collected during the study will be added to patient records. 
 
 
 
 
5. How will consent be obtained?  
 
Informed Consent Process (with or without a document) 
 
6. Describe all the procedures chronologically, from screening/enrollment through study closeout, which will be 
completed in the research project. 
This project is funded by the National Institute on Drug Abuse (NIDA) as a SBIR grant. BehaVR, LLC is the prime awardee and the 
University of Utah is BehaVR's academic partner for this project, as a subawardee. BehaVR will develop the MORE-VR virtual reality 
system with funding from NIDA. The University of Utah will conduct an initial pilot test of this system via the proposed study below: 
 
1. A sample of 30 patients receiving MOUD will be recruited from University of Utah Healthcare System, Highland Ridge Hospital, or self- 
referral. 
 
2. At the time of initial contact with the research team, the Principal Investigator, Study Coordinator, or Research assistant will explain 
the study and invite potential participants to ask questions. Potential participants will then be screened for eligibility.  Psychiatric and 
substance use disorders will be assessed with the Mini-International Neuropsychiatric Interview (MINI), a structured interview 
with good inter-rater and test-retest reliability.67 Opioid withdrawal will be assessed with the Clinical Opiate Withdrawal Scale 
(COWS).69 
3. Informed consent will be obtained from all eligible participants. 
 
4. Following screening and informed consent, eligible participants will be assessed for baseline clinical characteristics with the Addiction 
Severity Index, the Depression Anxiety Stress Scale (DASS), the Tobacco, Alcohol, Prescription Medications, and other 
Substances (TAPS), the Snaith Hamilton Pleasure and Anhedonia Scale (SHAPS), Metacognitive Processes of Decentering 
Scale (MPODS), the Nondual Awareness Dimensional Assessment, the Ways of Savoring Checklist, and the Emotion 
Regulation Questionnaire. 
 
5. Next, the sample (N=30) will participate in 8 weekly treatment sessions with the MORE-VR system. The VR system consists of 
commercially available VR goggles (e.g., Oculus Rift) linked with a VR platform consisting of a cloud-based control software that 
orchestrates the content of VR sessions in real-time. The VR content is based on Dr. Garland’s validated Mindfulness-Oriented Recovery 
Enhancement (MORE) protocol, published in 2013 (Garland, 2013, Mindfulness-Oriented Recovery Enhancement for Addiction, Stress, 
and Pain. NASW Press: Washington, DC.). Each session of MORE-VR will last approximately 1.5 hours, and a research staff will be 
present at each VR session, who will teach the participant to use the system and answer any questions that arise. 
 
6. The VR system will capture trace data through logs that capture behavioral engagement with each intervention component. These will 
include the number of digital object manipulations, clicks, and eye tracking of fixation duration on digital objects 
 
7. At the 8 weekly MORE-VR sessions, the following measures will be administered, for a total of 8 assessments: 
 
a) Craving will be evaluated with a Numeric Rating Scale and the Desires for Drug Questionnaire,72 and affect will be evaluated with the 

11 of 26 
7/14/2023, 3:02 PM 
 
 
 
Positive and Negative Affect Scale (PANAS).73 
b) Coping self-efficacy will be measured with the Drug Taking Confidence Questionnaire,74 which predicts heroin relapse.75 
c) Mindfulness will be evaluated with the Toronto Mindfulness Scale76 as a therapeutic process measure and manipulation check. 
 
d) Participants will complete a daily symptom diary of opioid craving, drug use and mood symptoms as well as mindfulness skills via 
ecological momentary assessments (EMA) delivered via the participant's own smartphone or home computer up to 3 times per day 
(morning, noon and evening). 
 
 
e) Also at this post-treatment assessment, we will again administer the following questionnaires: the DASS, the TAPS, SHAPS, 
MPODS, NADA, the Ways of Savoring Checklist, and the Emotion Regulation Questionnaire. 
 
f) Participants will participate in a semi-structured qualitative interview (sample questions attached as an additional document) about the 
acceptability of the MORE-VR system (e.g., "What did you like best? What didn't you like?" "What would you change?"). The interview 
will be audio-recorded and transcribed for analysis of intervention acceptability. 
 
g) Safety will be assessed throughout to monitor adverse events.  
 
 
 
 
7. Are all procedures for research purposes only (non-standard or non-standard of care procedures)? 
◆ Yes 
 No 
If no, list the procedures that are performed for research purposes only (non-standard or non-standard 
of care procedures): 
 
8. Is there a safety monitoring plan for this study? 
 Yes 
 No 
 
9. Provide a summary of the statistical methods, data analysis, or data interpretation planned for this study. 
Factors for determining the proposed sample size (e.g., power) should be stated. 
For this Phase I pilot focused on usability, satisfaction and safety, we are not powered to detect a change in proximal outcomes or 
mechanistic measures. Yet, the repeated-measures nature of our design affords comparatively high statistical power. With 8 
measurement points and a moderate repeated measures correlation (r=.30), we will have power of .90 to detect a medium effect size 
for the simple fixed effect of time (Cohen’s f=.25) with N=30. We assume at least a medium effect size based on the large effects of 
2 
15 
2 
time observed among participants treated with MORE in prior RCTs for craving,60 ηpartial =.24, and positive affect, 
ηpartial =.39. 
 
Safety will be evaluated with the sequential probability ratio test (SPRT)83 following updated guidelines for small, single arm trials.84,85 
Changes in craving, affect, and physiology (HR, HRV, GSR) across the 8 sessions will be assessed with linear mixed models (LMM) with 

12 of 26 
7/14/2023, 3:02 PM 
 
 
 
 
Kenwood-Roger degrees of freedom. Simple LMM with small sample sizes can provide unbiased estimates of fixed effects with minimal 
inflations in type I error.86 Because this is a non-experimental Phase I pilot study, the fixed effect of time will be the parameter of 
interest, controlling for OUD severity as a covariate. LMM will specify a random intercept, and random slopes and/or autoregressive 
repeated covariances if needed and supported by the Bayesian Information Criterion. However, given the small N, we will not over fit 
models to the point of saturation – models will be simple as possible. Little’s MCAR test will determine if data are Missing Completely at 
Random (an ideal that is rarely met with longitudinal data). There is no definitive test for Missing at Random, which describes data that 
are random conditional on observed data. We will use restricted maximum likelihood estimation (REML) procedures to deal with missing 
data according to an intent-to-treat philosophy that is robust against common patterns of missing data. REML is based on all data 
observations; no values are deleted. Sex differences in treatment response will be examined by including sex as a biological variable of 
interest in analytic models. 

13 of 26 
7/14/2023, 3:02 PM 
 
 
 
IRB_00141495 
Created: 
2/27/2021 11:56 
AM 
IRB_00141495 
- Consent Process 
 
PI: Eric Garland PhD/Associate Professor and 
Associate Director of Integrative Medicine 
 
Submitted: 
3/9/2021 
 
 
Title: Digital Therapeutic Development of Virtual Cognitive- 
Affective Training for Opioid 
Use Disorder 
 
 
Consent Process 
 
 
 
List by name, role, and affiliation any others who will obtain consent (e.g. Dr. John Smith, Co-Investigator, etc.). 
 
1. Describe the location(s) where consent will be obtained. 
Center on Mindfulness and Integrative Health Intervention Development, College of Social Work, University of Utah 
Highland Ridge Hospital 
Consenting via a HIPAA-compliant virtual meeting platform (e.g., Zoom) 
 
2. Describe the consent process(es), including the timing of consent. Describe whether there is a waiting period 
between the consent process and obtaining consent from the participant (i.e., any time between informing 

14 of 26 
7/14/2023, 3:02 PM 
 
 
 
 
3. Describe what measures will be taken to minimize the possibility of coercion or undue influence. 
Participants will be informed that taking part in this study is their choice. They will be 
informed that they may choose either to take part or not take part in the study, and if they 
choose not to participate in this research study, there will be no penalty to them, nor will their 
decision to participate or not participate affect their eligibility for care or any other benefits to 
which they are entitled. Participants will be informed that they may also leave the study at any 
time. They will be notified that if they leave the study before it is finished, there will be no 
penalty to them, and they will not lose any benefits to which they are entitled. 
 
4. Describe the provisions that are made to allow adequate time to exchange information and questions between 
the investigator and participant. 
During the informed consent process, the Principal Investigator, Study Coordinator, or 
Research Assistant will read, review, and discuss consent forms with all potential participants 
prior to signing. If the potential participant appears confused or indicates she does not 
understand the consent forms, the interviewer will attempt to identify what the individual 
does not understand and explain the consent again. The participant will be informed that there is no rush to complete 
informed consent and that they should wait until their questions are 
fully answered before signing. 
 
5. Will a legally authorized representative (LAR) be used? 
 Yes 
 No 
 
 
7. 
 
 
8. Are you requesting that documentation of informed consent be waived by the IRB (a consent process in place, 
but no documentation of consent, e.g. questionnaire cover letter, web-based consent, consent without 
signature, etc.)? 
 Yes 
 No 
 
If yes, complete the following: 
 
a. Explain why the waiver of consent documentation is being requested. 
 
 
b. Justification for the waiver is one of the following: 
There are no items to display 
participants and actually obtaining consent). 
The consent process will be performed by the study investigators, study coordinator, or research assistants. Dr. Garland 
will not obtain consent from participants. A potentially-eligible individual will schedule a time to meet with a member of 
the research staff, either in-person or using a HIPAA-compliant virtual meeting platform such as zoom, at which time the 
person obtaining consent will explain the protocol in detail and will review and discuss the consent form with the 
potential participant. The personnel who obtain consent will inform participants of Dr. Garland's financial conflict of 
interest in this study. If the potential participant appears confused or indicates she does not understand the consent 
forms, the interviewer will attempt to identify what the individual does not understand and explain the consent again. If 
the potential participant appears confused or indicates that they do not understand the consent forms, the interviewer 
will attempt to identity what the individual does not understand and explain the consent again. The potential participant 
will be offered up to 72 hours to make a decision to participate. If the potential participant elects to enroll, the Principal 
Investigator, Research Assistant, or Study Coordinator will witness and date the consent after the participant signs. 
Consent forms will be signed by the participant and the research team member conducting consent. A copy of the 
signed consent, including contact phone numbers for the PI and the University of Utah IRB, will be given to the subject. 
REDCap e-consent framework may be utilized to obtain electronic signatures and distribute signed copies of the 
consent. 
After consent has been obtained, the Coordinator or Research Assistant will schedule participants to begin the study 
intervention. 
Will a language other than English be used to obtain consent? 
 Yes 
 No 

15 of 26 
7/14/2023, 3:02 PM 
 
 
 
IRB_00141495 
Created: 
2/27/2021 11:56 
AM 
IRB_00141495 
5. Data Monitoring 
 
PI: Eric Garland PhD/Associate Professor and 
Associate Director of Integrative Medicine 
 
Submitted: 
3/9/2021 
 
 
Title: Digital Therapeutic Development of Virtual Cognitive- 
Affective Training for Opioid 
Use Disorder 
 
 
5. Data Monitoring Plan 
 
1. Privacy Protections: Privacy refers to persons and to their interest in controlling access of others to themselves. Privacy 
can be defined in terms of having control over the extent, timing and circumstances of sharing oneself (physically, 
behaviorally, or intellectually) with others. What precautions will be used to ensure subject privacy is protected? 
Select all that apply:  
 
The research intervention is conducted in a private place 
 
Discussing the study with participants individually instead of in front of a group 
 
The collection of information about participants is limited to the amount necessary to achieve the aims of the research, so 
that no unneeded information is being collected 
 
De-identification of photos, audio tapes, or video tapes of the participant that will be made during the study 
 
Other or additional details (specify): 
All materials derived from the study will be handled only by study personnel during collection, storage, and in 
subsequent data analysis. The PI is experienced in conducting clinical studies and is fully aware of the need for 
anonymity, privacy and security, and maintains strict surveillance of the office environment. No incidents of violation of 
patient confidentiality have occurred in the previous studies in which the PI has participated over the past 10 year 
period. 
 
Protection of Participant Identity and Confidentiality. The following confidentiality 
protection steps will be taken: 1) all members of the research team will participate in initial 
training and follow-up training in medical and research ethics; 2) consent forms will be 
maintained in password protected REDCap databases; 3) any personal identifiers linked to data will be removed and 
replaced by code numbers in all records; 4) any information suggesting that privacy has been breached will be 
thoroughly investigated by the PI and reported promptly to the IRB. 
 
Audio-recordings of interviews will be destroyed one year after completion of the project. 
2. Confidentiality Precautions: Confidentiality is an extension of the concept of privacy; it refers to the subject's 
understanding of, and agreement to, the ways identifiable information will be stored and shared. Identifiable information 
can be printed information, electronic information or visual information such as photographs. What precautions will be 
used to maintain the confidentiality of identifiable information? 
Select all that apply:  
 
Storing research data on password protected computers or in locked cabinets or offices 
Participant identifiers will be stored separately from the coded, participant data 
All data that will be transferred or transported outside of the institution will be encrypted 
Destroying photos, audio tapes, or video tapes at the end of the study 
A Certificate of Confidentiality (from the NIH) will be used 
 
Other or additional details (specify): 
Identifiers will be removed from participant data, and a key linking participant PHI (name, contact information, birthdate) 
back to their data will be maintained and stored separately. 
 
 
3.  Will photos, audio recordings, or video recordings, or medical images of participants be made 
during the study? 

16 of 26 
7/14/2023, 3:02 PM 
 
 
 
 
◆ Yes 
 No 
If yes, describe the recording/images and what will become of them after creation (e.g., 
shown at scientific meetings, stored in the medical/research record, transcribed, erased, 
etc.): 
The qualitative acceptability interviews will be audio-recorded and transcribed for analysis of the acceptability of 
MORE-VR. One year after the completion of the study, audio recordings will be destroyed. 
4. How will study data and documentation be monitored throughout the study? 
Select all that apply: 
Periodic review and confirmation of participant eligibility 
Periodic review of informed consent documentation 
Periodic review of the transfer/transcription of data from the original source to the research record 
Confirmation that all appropriate information has been reported to the sponsor, oversight agencies (such as the FDA), 
and/or IRB 
Other additional details (specify): 
5. Who will be the primary monitor of the study data and documentation? 
Select all that apply:  
 
Principal Investigator 
Study Coordinator or Research Nurse 
Research Assistant 
Other or additional details (specify): 
Other or additional details (specify): 
Gary Donaldson, Co-Investigator and Statistician, will also monitor study data.  
 
How often is study data and documentation monitoring planned (e.g., monthly, twice a 
year, annually, after N participants are enrolled, etc.)? 
Quarterly 

17 of 26 
7/14/2023, 3:02 PM 
 
 
 
IRB_00141495 
Created: 
2/27/2021 11:56 
AM 
IRB_00141495 
6. Risks and Benefits 
 
PI: Eric Garland PhD/Associate Professor 
and Associate Director of Integrative 
Medicine 
 
Submitted: 
3/9/2021 
 
 
Title: Digital Therapeutic Development of Virtual Cognitive- 
Affective Training for Opioid 
Use Disorder 
 
 
6. Risks and Beneﬁts 
 
1. Describe the reasonable foreseeable risks or discomforts to the participants: 
 
All reported symptoms that subjects attribute to the study interventions will be documented and investigated by the PI (who has over a 
decade of clinical expertise with persons with substance use disorders and chronic pain, as well as clinical research experience through 
several NIH-funded clinical trials), and reported immediately to the University of Utah IRB. Risks associated with mindfulness meditation are 
minimal. There is no evidence that mindfulness worsen the symptoms causes complications with opioid therapy. The relaxation experienced 
as part of mindfulness training is sometimes associated with transient sleepiness, lasting no more than a few hours. 
 
Participation in mindfulness meditation may also increase awareness of anxiety. Participants will be advised to inform the therapists of any 
significant shift in their symptoms for the worse while taking part in the interventions. Reports of such changes will be given to the PI, who 
will coordinate to interview the subject and make a determination of need concerning specific medical care or removal from the study. Events 
of this type are very uncommon, usually transient and pose minor barriers to the completion of this study. 
 
Participants may interpret the interventions as substitutes for usual, conventional medical 
care. All participants will continue to receive the same medical care from their physician that 
they would otherwise receive. They will be informed that they should continue such care just 
as if they were not enrolled in a study. Participants will be asked to inform study personnel if 
there is a change in medications or other medical care during the trial (both during treatment 
and follow-up), but patients and their physicians will not be dissuaded from changing medical 
management practices. 
 
While strict precautions will be implemented to protect patient confidentiality (detailed in the 
data monitoring plan in section 5 of the IRB application), there is the potential risk of a loss of 
confidentiality. Because potential participants will be asked about drug use, this could pose a risk to the participants given the illegal nature 
of their actions. 
 
The consent form will clearly specify that it is the option of the PI and the research team to withdraw a subject from the study should they 
prove to be a danger to self or others, or a significant disruption to the group. If participants appear intoxicated (as determined by meeting 
DSM-5 diagnostic criteria for alcohol, cocaine, opioid, amphetamine, or hallucinogen 
intoxication) or actively suicidal during study assessments or VR sessions, they will not be allowed to continue that session. Instead, they will 
be referred to the appropriate University of Utah Primary Care Clinic or Highland Ridge Hospital to receive medical evaluation by a physician, 
brief intervention by a psychologist or social worker, and more extensive mental health services, as needed. Alternatively, if the participant is 
determined to be a danger to self or others due to suicidal ideation or intoxication, university police will be alerted. Afterward, the PI will 
contact the participant in question and interview them to determine whether their substance use warrants exclusion from the study. 
 
Another risk relates to the potential for cybersickness, which is a side effect associated with the use of VR technology. Cybersickness is 
associated with a range of symptoms including nausea, dizziness, disorientation, headaches, sweating, and/or eye strain. 
 
The final risk relates to the measurement protocol. Because the virtual drug cue exposure and negative emotion regulation protocols involve 
the presentation of opioid- related cues and stressful experiences, there is a risk that they could trigger opioid cravings and psychological 
distress. Yet, it is very unlikely that such craving or distress will exceed that which would occur on an everyday basis, given that opioid cues 
(e.g., the sight of a heroin needle) are present in participants’ natural environments. To monitor for potential risk, participants will be asked 
to rate their stress and craving on two 10-point visual analogue scales (1 = none, 10 = extreme) before and after the virtual cue exposure 
and negative emotional regulation protocols, and then again at the end of the assessment session. In the unlikely event that participants 
report stress or craving resulting from cue exposure as determined by an elevation in craving or stress by 3 points from baseline levels that 
maintains at the end of the assessment, the PI will notify the University of Utah IRB, and make a referral for clinical services, as appropriate. 
To mitigate this risk, the Study Coordinator/Research Assistant (a master’s level social worker) will be trained by the PI (a licensed clinical 
social worker and clinician with over 16 years of experience) to debrief participants, assess risk, and provide 15 minutes of progressive 
muscle relaxation to ensure subjects have experienced a reduction in stress or craving to a level of within 3 points of their baseline level on 
the visual analogue scales upon beginning the psychophysiological protocol. In two four RCTs of MORE with persons with substance use 
disorders, the PI used a similar risk management strategy for a psychophysiological cue-reactivity protocol, and no participants 
remained distressed after this procedure. 

18 of 26 
7/14/2023, 3:02 PM 
 
 
 
2. Describe the potential benefits to society AND to participants (do not include compensation): 
 
While it is possible that there may be no direct benefits to participants, the potential benefits 
of the research to the participants are significant. Their craving or stress may improve significantly as a result of being part of the study. 
The process of participating in the MORE-VR could enhance self-efficacy. Participants may learn improved methods of managing OUD from 
each other’s experience. Therefore, it is expected that participants may experience significant benefit from participating in the research 
study. The potential benefits to other individuals with OUD are also significant. The results of this research may provide credible evidence 
about the effects of MORE-VR for patients with OUD and whether it may be usefully integrated with conventional care in order to effectively 
manage opioid misuse and addiction. 
 
 
4. Is there any compensation to the participants? 
 
◆ Yes 
 No 
a. If yes, answer the following: 
Specify overall amount: 
$250 
b. Specify when participants will be paid (e.g. at each visit, at end of study, etc.): 
Participants will be paid at each visit. 
c. If applicable, please specify payment by visit or other time interval (e.g. $10 per visit, etc.): 
Participants will be paid $25 for the baseline and post-treatment assessment, $20 per MORE-VR session, plus an 
additional $40 bonus for completing 5 or more MORE-VR sessions. 
d. If applicable, explain plan for prorating payments if participant does not complete the study: 
Payment will be prorated according to how many study sessions are completed. 
3.  Are there any costs to the participants from participation in research? 
 Yes 
 No 
If yes, specify: 

19 of 26 
7/14/2023, 3:02 PM 
 
 
 
IRB_00141495 
Created: 
2/27/2021 11:56 
AM 
IRB_00141495 
7. HIPAA & the Covered Entity 
 
PI: Eric Garland PhD/Associate 
Professor and Associate Director of 
Integrative Medicine 
 
Submitted: 
3/9/2021 
 
 
Title: Digital Therapeutic Development of Virtual 
Cognitive-Affective Training for Opioid 
Use Disorder 
 
 
7. HIPAA and the Covered Entity 
 
 
1. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Does this study involve any of the following: 
 
2.   The investigational use of a drug? 
 Yes 
 No 
 
3. 
 
 
4.   Is this an investigator-initiated drug or device trial lead by the Principal Investigator? 
 Yes 
 No 
 
5. 
 
 
6.  A Humanitarian Device Exemption (HDE)? 
 Yes 
 No 
 
7. 
 
 
8.   Creating or sending data and/or samples to a repository to be saved for future research 
uses? 
 Yes 
 No 
Does this study involve Protected Health Information (PHI) or de-identified health 
information? 
◆ Yes 
 No 
a. Select the method(s) of authorization that will be used:  
 
Waiver or Alteration of Authorization 
b. Will PHI be disclosed outside the Covered Entity? 
◆ Yes 
 No 
To whom? 
FDA 
And for what purposes? 
Because this study involves the use of an investigational medical device, the FDA may receive PHI. 
The investigational use of a medical device? 
 Yes 
 No 
Exposure to radioisotopes or ionizing radiation? 
 Yes 
 No 
Genetic testing and/or analysis of genetic data? 
 Yes 
 No 

20 of 26 
7/14/2023, 3:02 PM 
 
 
 
 
Any component of the Clinical and Translational Science Institute (CTSI)? 
 Yes 
 No 
The Clinical Research Center (CRC)? 
 Yes 
 No 
9. Are you: 
▪ Collecting samples of blood, organs or tissues from participants for research purposes; 
▪ Introducing Recombinant or Synthetic Nucleic Acids (e.g. viral vectors, oligonucleotides) or cells 
containing recombinant nucleic acids (e.g. CAR-T) into participants; OR 
▪ Introducing other biological materials (e.g. bacteria, viruses) into participants. 
 Yes 
 No 
10. Does this study involve any of the following? 
▪ Cancer Patients 
▪ Cancer Hypothesis 
▪ Cancer risk reduction 
▪ Cancer prevention 
 Yes 
 No 
11. 

21 of 26 
7/14/2023, 3:02 PM 
 
 
 
IRB_00141495 
Created: 
2/27/2021 
11:56 AM 
IRB_00141495 
- Request for Waiver of Authorization 
 
PI: Eric Garland PhD/Associate 
Professor and Associate Director 
of Integrative Medicine 
 
Submitted: 
3/9/2021 
 
 
Title: Digital Therapeutic Development of Virtual 
Cognitive-Affective Training for Opioid 
Use Disorder 
 
 
Date Created 
Type of Request 
Purpose of Waiver Request 
Request for Waiver or Alteration of Authorization 
Request for Waiver of Authorization for Recruitment Only 
This option must only be used if you are reviewing PHI in order to identify eligible participants BEFORE approaching them to obtain consent and 
authorization.  All other waiver requests must be entered below. 
Waiver of Authorization for Recruitment Requested 
Other Requests for Waivers of Authorization: 
▪ Click "Add" below to add a new waiver request to this application. 
▪ Click the waiver name link to edit a waiver that has already been created. 
▪ To delete a waiver request, contact the IRB. 
There are no items to display 

22 of 26 
7/14/2023, 3:02 PM 
 
 
 
IRB_00141495 
Created: 
2/27/2021 
11:56 AM 
IRB_00141495 
Waiver of Authorization for Recruitment Only 
 
PI: Eric 
Garland PhD/Associate 
Professor and Associate 
Director of Integrative 
Medicine 
 
Submitted: 
3/9/2021 
 
 
Title: Digital Therapeutic Development of 
Virtual Cognitive-Affective Training for 
Opioid 
Use Disorder 
 
Request for Waiver or Alteration of Authorization 
 
 
Request for Waiver of Authorization for Recruitment Only 
 
The PI must agree to the terms of this waiver request as described on this page. 
When the PI uses the “Submit” activity to submit the application for IRB review, a 
checkbox to accept the terms will be available in the “Submit” activity window. 
 
This waiver request includes justification for waivers of consent for recruitment 
only, according to 45 CFR 46.116(d). 
 
Terms for the Waiver of Authorization: 
 
The purpose of this waiver of authorization is to allow for the use of PHI in 
order to identify and recruit individuals who may be eligible to participate in 
the specific research described in this IRB application. The waiver of 
authorization is necessary to accommodate this minimal-risk research 
activity prior to seeking a full authorization from research participants. 
 
Methods for identifying individuals may include the following: 
oReviewing medical charts 
oReviewing databases that include PHI 
oReviewing other medical- or health-based documents that include PHI 
 
Identifiable information used under this waiver may include the following, 
as this is the minimum necessary for identifying eligible individuals: 
oName 
o Contact information, such as phone number, address, or email address 
o An ID number, such as MRN or SSN 
oDate of birth 
oMedical and health information that may determine study eligibility 
 
Any PHI recorded by the study team will only be used for recruitment and 
determining study eligibility. After this has been completed, the PHI must be 
removed from the research record or destroyed, unless the participants have 
given authorization for continued use of the PHI. 
 
PHI will only be viewed by approved members of the study team and will not 
be disclosed for research purposes to any individual or institution without the 
participants’ authorization for such use and disclosure of the PHI. 
 
PHI will be stored in a secure manner according to HIPAA privacy 
and security provisions. 

23 of 26 
7/14/2023, 3:02 PM 
 
 
 
IRB_00141495 
Created: 
2/27/2021 
11:56 AM 
IRB_00141495 
8. Resources and Responsibilities 
 
PI: Eric Garland PhD/Associate 
Professor and Associate Director of 
Integrative Medicine 
 
Submitted: 
3/9/2021 
 
 
Title: Digital Therapeutic Development of Virtual 
Cognitive-Affective Training for Opioid 
Use Disorder 
 
 
 
* State and justify the qualifications of the study staff: 
Utah Principal investigator: Eric Garland, PhD, LCSW, is a licensed clinical social worker with 16 years of post-licensure experience and 
Associate Dean for Research and Professor, College of Social Work at the University of Utah, Director of the Center on Mindfulness and 
Integrative Health Intervention Development: oversee all research activities; hire, train, and supervise study staff; triage adverse events; 
manuscript preparation. Dr. Garland is the developer of MORE who has led 8 successful RCTs and multiple psychophysiological studies of 
MORE as a treatment for OUD, opioid misuse, and other addictive behaviors. 
Gary Donaldson, PhD (Utah Co-I) is Senior Strategic Statistician at University of Utah who has been PI on 5 NIH-funded studies 
and Director of Biostatistics Core on 2 NIH program projects. Dr. Donaldson will perform blinded statistical analyses of outcome 
data. 
Study personnel: Study personnel include postdoctoral fellows, graduate research assistants, and undergraduate research assistants. All 
personnel are well-trained in study procedures and have experience in prior clinical trials of MORE and mindfulness for opioid misuse and 
addiction. 
* Describe the facilities where the research activities will be performed (e.g. hospitals, 
clinics, laboratories, classrooms/schools, offices, tissue banks, etc.). 
A private psychophysiology laboratory at the Center on Mindfulness and Integrative Health Intervention Development (C-MIIND), 
University of Utah. 
A private treatment room at Highland Ridge Hospital. 
No data will be shared with external collaborators until all needed agreements are in place with the UU's Partners for Innovation, 
Ventures, Outreach &Technology, or PIVOT Center. 
8. Resources and Responsibilities 
1. 
2. * Describe the training that study staff and investigators will receive in order to be informed 
about the protocol and understand their research-related duties and functions: 
The entire study team has completed an IRB-approved human subjects training course and is 
knowledgeable about issues covered in the training. All investigators and research assistants will be trained by the PI on data collection 
and protocol in handling PHI. The PI has developed a training protocol for research assistants to learn all lab procedures. The training 
protocol involves: 
1. Completing a mock assessment in the role of a "subject" as conducted by trained personnel; 
2. Shadowing trained personnel for two assessments with actual participants; 
3. Conducting an assessment while supervised by trained personnel until complete proficiency is attained; and 
4. data review by the PI to ensure quality data collection with no mistakes 
3. 
4.   * Describe the medical or psychological resources available at this site (and other 
participating sites, if applicable) that participants might require as a consequence of the 
research. If not applicable, please state. 
Licensed clinical psychologists and licensed clinical social workers are on staff at both locations to provide psychological resources as 
needed. At Highland Ridge Hospital, physicians and nurses are available to provide medical resources as needed. At C-MIIND, medical 
resources can be provided by Madsen Health Center, which is a 3 minute drive away. 

24 of 26 
7/14/2023, 3:02 PM 
 
 
 
IRB_00141495 
Created: 
2/27/2021 11:56 
AM 
IRB_00141495 
Documents and Attachments 
 
PI: Eric Garland PhD/Associate 
Professor and Associate Director of 
Integrative Medicine 
 
Submitted: 
3/9/2021 
 
 
Title: Digital Therapeutic Development of Virtual 
Cognitive-Affective Training for Opioid 
Use Disorder 
 
Documents and Attachments 
 
If any of your documents (such as investigational brochures, sponsor protocols, advertisements, etc.) are not available in an electronic format, please scan 
and save them as PDF files or contact our office for assistance. 
 
Naming Documents: Please use the title field to clearly indicate the content of each form. The name you enter will be listed on your approval letter. Use 
names that will differentiate from earlier versions. 
 
Examples: 
Consent Document Control Group 04/14/05 
Consent Document Treatment Group 4/14/05 
Sponsor Protocol 04/14/05 Version 2 
Assent Document(Highlighted Changes) 
 
Apple/Macintosh Users:MS Word documents must have a .doc file extension. See ERICA home page for instructions. 
 
 
 
Print View: IRB Draft Protocol Summary 
 
 
eProtocol Summary: 
 
There are no items to display 
 
Consent Documents, Consent Cover Letters, Consent Information Sheets, Consent Scripts, etc.: 
 
There are no items to display 
 
Parental Permission Documents: 
 
There are no items to display 
 
Assent Documents: 
 
There are no items to display 
 
VA Consent Documents: 
 
There are no items to display 
 
Surveys, Questionnaires, Interview Scripts, etc.: 
 
There are no items to display 
 
Full Protocol (company protocol, sponsor protocol, investigator-initiated protocol, etc.): 
 
There are no items to display 
Name 
Version 
Date Created 
Date Modified 
Date Approved 
Name 
Version 
Date Created 
Date Modified 
Date Approved 
Name 
Version 
Date Created 
Date Modified 
Date Approved 
Name 
Version 
Date Created 
Date Modified 
Date Approved 
Name 
Version 
Date Created 
Date Modified 
Date Approved 
Name 
Version 
Date Created 
Date Modified 
Date Approved 
Name 
Version 
Date Created 
Date Modified 
Date Approved 

25 of 26 
7/14/2023, 3:02 PM 
 
 
 
 
Name 
Version 
Date Created 
Date Modified 
Date Approved 
Name 
Version 
Date Created 
Date Modified 
Date Approved 
Name 
Version 
Date Created 
Date Modified 
Date Approved 
Name 
Version Date Created 
Date Modified 
Date 
Approved
Name 
Version 
Date Created 
Date Modified 
Date Approved 
Name 
Version 
Date Created 
Date Modified 
Date Approved 
Name 
Version 
Date Created 
Date Modified 
Date Approved 
Name 
Version 
Date Created 
Date Modified 
Date Approved 
Investigational Brochure (IB) for Investigational Drug or Drug/Device Package Insert: 
There are no items to display 
Grant Application: 
The Federal Government is a direct or indirect sponsor of your research. You are required to provide a copy of the grant 
proposal, grant award, or sub-award. 
By submitting to the IRB, you are confirming the grant and the study protocol are consistent (Design, Study Population, 
Study Objectives and Goals, Test Interventions and Procedures, etc.) 
There are no items to display 
Literature Cited/References:
There are no items to display 
Principal Investigator's Scholarly Record (CV/Resume): 
  GARLAND_CV_CURRENT_2022.pdf(0.01) 
0.01 
4/13/2022 8:34 
4/13/2022 8:34 
AM 
AM 
Faculty Sponsor's Scholarly Record (CV/Resume): 
There are no items to display 
Other Stamped Documents: 
There are no items to display 
Recruitment Materials, Advertisements, etc.: 
There are no items to display 
Other Documents: 
There are no items to display 

26 of 26 
7/14/2023, 3:02 PM 
 
 
 
IRB_00141495 
Created:2/27/2021 
11:56 AM 
IRB_001414F9i5nish 
 
PI: Eric Garland PhD/Associate Professor and 
Associate Director of Integrative Medicine 
 
Submitted: 
3/9/2021 
 
 
Title: Digital Therapeutic Development of Virtual Cognitive-Affective 
Training for Opioid 
Use Disorder 
 
 
 
Finish Instructions 
Finish Instructions 
1. To view errors, select the "Validate" option at the top-left of the page. If you have errors on your application, 
you won't be able to submit it to the IRB. 
2. Selecting the Finish button will NOT submit the application to the IRB. 
You MUST select the "Submit" option on the workspace once you've selected the "Finish" button. 
3. If your study has a faculty sponsor: Once the PI submits the application, it will be sent to the faculty sponsor 
for final approval. The IRB cannot review the study until the faculty sponsor submits the application to the IRB.