NCT05908097

Enhancing Prospective Thinking in Early Recovery (PARK)

Enhancing Prospective Thinking in Early Recovery

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Opioid Use
• Opioid Use Disorder
• Substance Use Disorders

Interventions

Type	Name	Description
DEVICE	Virtual Reality Avatar Intervention	In the Virtual Reality Avatar Intervention experience, participants will see an avatar resembling themselves in a park setting.
DEVICE	Virtual Reality Empty Park	The Virtual Reality Empty Park experience is a habituation experience that does not contain avatars.

Timeline

• Start date: 2023-04-04
• Primary completion: 2025-09-14
• Completion: 2025-09-14
• First posted: 2023-06-18
• Last updated: 2026-01-13

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study