Enhancing Prospective Thinking in Early Recovery (PARK)
Study Details
Study Description
Brief Summary
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.
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Will the VR group, compared to the control group, have a lower number of opioid use days?
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Will the VR group, compared to the control group, have longer periods of abstinence at the 30-day follow-up?
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Will the VR group, compared to the control group, have significantly increased opioid abstinence rates?
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Will the VR group, compared to baseline and the control group, show increased future self-identification post-VR intervention?
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Will the VR group, compared to baseline and the control group, show increased future orientation post-VR intervention?
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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?
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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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Virtual Reality 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
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.
Device: Virtual Reality Empty Park
The Virtual Reality Empty Park experience is a habituation experience that does not contain avatars.
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| Placebo Comparator: Treatment As Usual (Control) Participants in this arm will receive the following interventions: Treatment As Usual (Empty Virtual Reality Park) |
Device: Virtual Reality Empty Park
The Virtual Reality Empty Park experience is a habituation experience that does not contain avatars.
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Outcome Measures
Primary Outcome Measures
- Reduced Use of Drug Using Days [Study Day Visit; 30-day Follow-up Visit.]
The VR Avatar experience will change drug using days.
- Increased Length of Abstinence [Study Day Visit (Day 1); 30-day Follow-up Visit.]
The VR Avatar experience will change the length of abstinence periods.
- Change in Overall Abstinence [Study Day Visit (Day 1); 30-day Follow-up Visit.]
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.
- Future Self-Identification [Study Day Visit (Day 1); 30-day Follow-up Visit]
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.
- Future Time Orientation [Study Day Visit (Day 1); 30-day Follow-up Visit.]
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.
- Delayed Reward [Study Day Visit (Day 1); 30-day Follow-up Visit.]
The Virtual Reality Avatar experience will change preference for delayed rewards, which will be measured using a behavioral delay discounting task.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Abstinence between ≥14 days and ≤ 6 months
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18-60 years old
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Verbal endorsement of commitment to recovery
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Outpatient
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Psychotropic drugs for SUD-comorbidity
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Mu-Opioid drugs
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Drug/alcohol abstinence ≥ 24 hours at the time of the study day visit
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English comprehension
Exclusion Criteria:
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Unstable medical disorders
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Outside the age range of 18-60
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Habitual drug use
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Smell/taste disorders
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Unstable psychiatric conditions
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Extravagant/elaborate face tattoos
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Indiana University School of Medicine - Goodman Hall | Indianapolis | Indiana | United States | 46202 |
| 2 | IUSM - Goodman Hall | Indianapolis | Indiana | United States | 46202 |
Sponsors and Collaborators
- Indiana University
- National Institute on Drug Abuse (NIDA)
Investigators
- Principal Investigator: Brandon G Oberlin, PhD, Indiana University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1805574553; Aims 7-8
- PARK
- 1R41DA055405-01