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NCT05908097 · ClinicalTrials.gov registry record · Early Phase 1
Enhancing Prospective Thinking in Early Recovery (PARK)
A Early Phase 1 study of Opioid Use Disorder and Opioid Use, sponsored by Indiana University.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 104
- Enrollment target
- 3
- Study locations
NCT05908097: Completed Early Phase 1 study of Opioid Use Disorder and Opioid Use, sponsored by Indiana University.
NCT05908097 is a Early Phase 1 study of Opioid Use Disorder and Opioid Use that has completed, run by Indiana University. The registered enrollment target is 104 participants, below the 4,656-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (98% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05908097, a Early Phase 1 study of Opioid Use Disorder and Opioid Use, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 104 participants
- Enrollment target
- 3
- Study locations
Study 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.
Primary Outcome
The VR Avatar experience will change drug using days.
Conditions Studied
Interventions
- DEVICE Virtual Reality Avatar Intervention
- DEVICE Virtual Reality Empty Park
Study Locations (3)
Indiana
- Indiana University School of Medicine - Goodman Hall - Indianapolis
- IUSM - Goodman Hall - Indianapolis
Oregon
- Serenity Lane Alcohol & Drug Treatment - Coburg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 104 participants |
| Start Date | 2023-04-04 |
| Est. Completion | 2025-09-14 |
| Phase | Early Phase 1 |
What the finished NCT05908097 record still lists
NCT05908097 is an interventional study that assigns participants to a tested intervention. The registered 104 participants enrollment target is mid-sized for trials with a published cap, below the 4,656-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (98% lower).
The record links to 3 conditions, with Opioid Use Disorder appearing as the primary indexed condition, and to 2 interventions - of which Virtual Reality Avatar Intervention is the first listed.
NCT05908097 reports a single indexed study location in Indiana, Oregon.
Frequently Asked Questions
What is clinical trial NCT05908097 about?
NCT05908097 is a clinical study titled "Enhancing Prospective Thinking in Early Recovery (PARK)". 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 ...
What is the current status of trial NCT05908097?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 104 participants. The study started on 2023-04-04. Estimated completion is 2025-09-14.
What conditions does trial NCT05908097 study?
This clinical trial studies the following conditions: Opioid Use Disorder, Opioid Use, Substance Use Disorders.
What interventions are being tested in trial NCT05908097?
The interventions under investigation include: Virtual Reality Avatar Intervention (DEVICE), Virtual Reality Empty Park (DEVICE).
Who is sponsoring clinical trial NCT05908097?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05908097 being conducted?
This trial has 3 study locations across Indiana, Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05908097's enrollment target sits among peer trials
104 127th of 257 higher than 130 of 257 other Opioid Use Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Opioid Use Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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