Enhancing Prospective Thinking in Early Recovery (PARK) (PARK)

Enhancing Prospective Thinking in Early Recovery

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.

Study Overview

• Status: Completed
• Conditions: Opioid Use Disorder; Substance Use Disorders; Opioid Use
• Intervention / Treatment: Device: Virtual Reality Empty Park; Device: Virtual Reality Avatar Intervention

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University School of Medicine - Goodman Hall
    • Indianapolis, Indiana, United States, 46202
      • IUSM - Goodman Hall
  • Oregon
    • Coburg, Oregon, United States, 97402
      • Serenity Lane Alcohol & Drug Treatment

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Brandon G Oberlin, PhD, Indiana University

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2023
• Primary Completion (Actual): September 14, 2025
• Study Completion (Actual): September 14, 2025

Study Registration Dates

• First Submitted: May 5, 2023
• First Submitted That Met QC Criteria: June 8, 2023
• First Posted (Actual): June 18, 2023

Study Record Updates

• Last Update Posted (Actual): January 13, 2026
• Last Update Submitted That Met QC Criteria: January 12, 2026
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Narcotic-Related Disorders; Mental Disorders; Chemically-Induced Disorders; Opioid-Related Disorders; Substance-Related Disorders
• Other Study ID Numbers: 1805574553; Aims 7-8; PARK (Other Identifier: IndianaU); 1R41DA055405-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The IPD will be shared in accordance with the National Institutes of Health National Data Archive requirements and upon the consent of the study participant.
• IPD Sharing Time Frame: Data will be shared at the specified submission deadlines assigned by the National Institutes of Health (typically every April or October). Data will be available upon the discretion of the National Institutes of Health.
• IPD Sharing Access Criteria: No individually identifiable participant data will be submitted to the National Data Archive. All collected participant data is de-identified, and will be made available for other researchers to use upon requests submitted through the National Data Archive portal, and approval from the principal investigator.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No