Enhancing Prospective Thinking in Early Recovery (PARK)
- Conditions
- Substance Use DisordersOpioid UseOpioid Use Disorder
- Interventions
- Device: Virtual Reality Avatar InterventionDevice: Virtual Reality Empty Park
- Registration Number
- NCT05908097
- Lead Sponsor
- Indiana University
- 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.
* 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- 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
- Unstable medical disorders
- Outside the age range of 18-60
- Habitual drug use
- Smell/taste disorders
- Unstable psychiatric conditions
- Extravagant/elaborate face tattoos
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Virtual Reality Virtual Reality Empty Park Participants in this arm will receive the following interventions: Treatment As Usual (Empty Virtual Reality Park) Virtual Reality Avatar (Intervention) Virtual Reality Virtual Reality Avatar Intervention Participants in this arm will receive the following interventions: Treatment As Usual (Empty Virtual Reality Park) Virtual Reality Avatar (Intervention) Treatment As Usual (Control) Virtual Reality Empty Park Participants in this arm will receive the following interventions: Treatment As Usual (Empty Virtual Reality Park)
- Primary Outcome Measures
Name Time Method 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.
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.
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.
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.
Reduced Use of Drug Using Days Study Day Visit; 30-day Follow-up Visit. The VR Avatar experience will change drug using days.
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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
IUSM - Goodman Hall
🇺🇸Indianapolis, Indiana, United States
Indiana University School of Medicine - Goodman Hall
🇺🇸Indianapolis, Indiana, United States