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OpenTrials
Completed

NCT Number: NCT05908097

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 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.

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Key information

Conditions

Opioid Use Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid Use Disorder Opioid-Related Disorders Substance Use Disorders Substance-Related Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

IUSM - Goodman Hall, Indianapolis, Indiana, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 Empty Park

Device

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

Primary outcomes

  1. Reduced Use of Drug Using Days

    Time frame: Study Day Visit; 30-day Follow-up Visit.

    The VR Avatar experience will change drug using days.

  2. Increased Length of Abstinence

    Time frame: Study Day Visit (Day 1); 30-day Follow-up Visit.

    The VR Avatar experience will change the length of abstinence periods.

  3. Change in Overall Abstinence

    Time frame: 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.

  4. Future Self-Identification

    Time frame: 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.

  5. Future Time Orientation

    Time frame: 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.

  6. Delayed Reward

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Enhancing Prospective Thinking in Early Recovery

Acronym: PARK

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 18, 2023
Registry last updated
Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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