Enhancing Prospective Thinking in Early Recovery (PARK)

Study Overview
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Brief Summary
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The goal of this clinical trial is to demonstrate the commercial potential for a novel virtual reality (VR) intervention in preparation for Phase II development. This clinical trial will test the VR intervention for efficacy in reducing opioid use, increasing abstinence, and other self-reported and behavioral focus on future outcomes in individuals in early recovery from opioid use disorder. Will the VR group, compared to the control group, have a lower number of opioid use days? Will the VR group, compared to the control group, have longer periods of abstinence at the 30-day follow-up? Will the VR group, compared to the control group, have significantly increased opioid abstinence rates? Will the VR group, compared to baseline and the control group, show increased future self-identification post-VR intervention? Will the VR group, compared to baseline and the control group, show increased future orientation post-VR intervention? Will the VR group, compared to baseline and the control group, show an increased preference for delayed rewards in a laboratory delay discounting task post-VR intervention? Will the VR group, compared to baseline and the control group, exceed in behavioral effects (i.e., future self-identification, future orientation, and increased preference for delayed rewards) at the 30-day follow-up? Researchers will compare the VR test group and the control group to see if there are differences in the results for the questions outlined above.

Official Title
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Enhancing Prospective Thinking in Early Recovery

Conditions
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Opioid Use, Opioid Use Disorder, Substance Use Disorders

Intervention / Treatment
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* Device: Virtual Reality Avatar Intervention
* Device: Virtual Reality Empty Park


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Abstinence between ≥14 days and ≤ 1 year 18-60 years old Verbal endorsement of commitment to recovery Outpatient Psychotropic drugs for SUD-comorbidity Mu-Opioid drugs Drug/alcohol abstinence ≥ 24 hours at the time of the study day visit English comprehension Exclusion Criteria: Unstable medical disorders Outside the age range of 18-60 Habitual drug use Smell/taste disorders Unstable psychiatric conditions Extravagant/elaborate face tattoos

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two groups: Experimental and Control
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual Reality<br>Participants in this arm will receive the following interventions: Treatment As Usual (Empty Virtual Reality Park) Virtual Reality Avatar (Intervention) | Device: Virtual Reality Avatar Intervention<br>* In the Virtual Reality Avatar Intervention experience, participants will see an avatar resembling themselves in a park setting. The Virtual Reality Empty Park experience is a habituation experience that does not contain avatars.<br>Device: Virtual Reality Empty Park<br>* The Virtual Reality Empty Park experience is a habituation experience that does not contain avatars.<br>|
| Placebo Comparator: Treatment As Usual (Control)<br>Participants in this arm will receive the following interventions: Treatment As Usual (Empty Virtual Reality Park) | Device: Virtual Reality Empty Park<br>* The Virtual Reality Empty Park experience is a habituation experience that does not contain avatars.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduced Use of Drug Using Days | The VR Avatar experience will change drug using days. | Study Day Visit; 30-day Follow-up Visit. | 
| Increased Length of Abstinence | The VR Avatar experience will change the length of abstinence periods. | Study Day Visit (Day 1); 30-day Follow-up Visit. | 
| Change in Overall Abstinence | The VR Avatar experience, compared to treatment as usual will change abstinence, measured using a timeline follow-back assessing for substances used from enrollment to study completion. | Study Day Visit (Day 1); 30-day Follow-up Visit. | 
| Future Self-Identification | The VR Avatar Experience will change future self-identification. Future self-identification and change between two time points will also be measured using a proprietary future-self-continuity assessment administered at Study Day Visit (Day 1), and again at the 30-Day Follow-up Visit. | Study Day Visit (Day 1); 30-day Follow-up Visit | 
| Future Time Orientation | The Virtual Reality Avatar experience will change orientation toward the future, which will be measured using the Zimbardo Time Perspective Inventory (ZTPI). The ZTPI contains five subscales, and items within each subscale are scored from 1, very uncharacteristic, to 5, very characteristic. The subscales are 1) Past-Negative--10 items, higher scores indicative of worse outcomes; 2) Present-Hedonistic--15 items, higher scores indicative of worse outcomes; 3) Future--10 items, higher scores indicative of better outcomes; 4) Past-Positive--9 items, higher scores indicative of better outcomes; and 5) Present-Fatalistic--9 items, higher scores indicative of worse outcomes. Subscales are combined into future and present categories, then totaled, with higher total scores indicative of worsened outcomes. | Study Day Visit (Day 1); 30-day Follow-up Visit. | 
| Delayed Reward | The Virtual Reality Avatar experience will change preference for delayed rewards, which will be measured using a behavioral delay discounting task. | Study Day Visit (Day 1); 30-day Follow-up Visit. |