Enhancing Prospective Thinking in Early Recovery (PARK)

NCT05908097 | Completed Early Phase 1 DMC FDA Device

• 3 other identifiers: 1805574553; Aims 7-8PARK1R41DA055405-01
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 3

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.

Conditions

Substance Use Disorders; Opioid Use; Opioid Use Disorder

Outcome Measures

Primary Outcomes (6)

• 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.

Study Arms (2)

Virtual Reality

EXPERIMENTAL

Participants in this arm will receive the following interventions: Virtual Reality Avatar VR plus Treatment As Usual (Intervention)

Device: Virtual Reality Avatar Intervention; Device: Virtual Reality Empty Park

Sham VR (Control)

SHAM COMPARATOR

Participants in this arm will receive the following interventions: Sham VR plus Treatment As Usual (Empty Virtual Reality Park)

Device: Virtual Reality Empty Park

Interventions

Virtual Reality Avatar Intervention DEVICE

In the Virtual Reality Avatar Intervention experience, participants will see an avatar resembling themselves in a park setting.

Virtual Reality

Virtual Reality Empty Park DEVICE

The Virtual Reality Empty Park experience is a habituation experience that does not contain avatars.

Sham VR (Control); Virtual Reality

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Abstinence between ≥14 days and ≤ 1 year
• 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

You may not qualify if:

• Unstable medical disorders
• Outside the age range of 18-60
• Habitual drug use
• Smell/taste disorders
• Unstable psychiatric conditions
• Extravagant/elaborate face tattoos

Sponsors & Collaborators

• Indiana University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (3)

Indiana University School of Medicine - Goodman Hall

Indianapolis, Indiana, 46202, United States

Location

IUSM - Goodman Hall

Indianapolis, Indiana, 46202, United States

Location

Serenity Lane Alcohol & Drug Treatment

Coburg, Oregon, 97402, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Brandon G Oberlin, PhD

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: All study participants are randomly assigned to a group prior to study enrollment. Participants will not be made aware of their group assignment.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Two groups: Experimental and Control

Study Record Dates

• First Submitted: May 5, 2023
• First Posted: June 18, 2023
• Study Start: April 4, 2023
• Primary Completion: September 14, 2025
• Study Completion: September 14, 2025
• Last Updated: January 13, 2026

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• 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.
• 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.

Locations

US (3)