RENTS: Enhancing Prospective Thinking in Early Recovery

Sponsor
Indiana University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05835921
Collaborator
National Institute on Drug Abuse (NIDA) (NIH)
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37.1
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Study Details

Study Description

Brief Summary

The goal of this clinical trial is to use a novel virtual reality intervention to test for efficacy in reducing stimulant use and increasing abstinence, with concomitant increases in future self-identification, future time perspective, and delay-of-reward, in early recovering stimulant use disorder (StUD) persons. The main question[s] this trial aims to answer are:

  • Will the Virtual Reality (VR) intervention decrease the number of stimulant use days?

  • Will the VR intervention produce longer abstinence periods during follow-up visits?

  • Will the VR intervention increase stimulant drug abstinence rates?

  • Will the VR intervention increase future self-identification?

  • Will the VR intervention increase self-reported future time perspective?

  • Will the VR intervention increase preference for delayed rewards in a laboratory delay discounting task on the study day?

  • Will the VR intervention produce gains in the behavioral effects of future self-identification, future time perspective, and delayed rewards at the 30-day and 6-month follow-ups?

Researchers will compare the experimental and control groups to see if there are differences in the results for the questions outlined above.

Condition or Disease Intervention/Treatment Phase
  • Device: Virtual Reality
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
88 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Two groups: Experimental Group Control GroupTwo groups:Experimental Group Control Group
Masking:
Single (Participant)
Masking Description:
All study participants are randomly assigned to a group prior to study enrollment. Participants will not be made aware of their group assignment.
Primary Purpose:
Basic Science
Official Title:
Enhancing Prospective Thinking in Early Recovery
Actual Study Start Date :
Mar 28, 2023
Anticipated Primary Completion Date :
May 1, 2025
Anticipated Study Completion Date :
May 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Virtual Reality

Participants in this arm will receive the following interventions: Virtual Reality Park Virtual Reality Avatar

Device: Virtual Reality
Both groups will receive a Virtual Reality Park experience, which is an empty park with no avatars. Only the experimental group will have a Virtual Reality Avatar experience, where they will see an avatar resembling themselves in a park setting.

Placebo Comparator: Treatment As Usual

Participants in this arm will receive the following interventions: Virtual Reality Park

Device: Virtual Reality
Both groups will receive a Virtual Reality Park experience, which is an empty park with no avatars. Only the experimental group will have a Virtual Reality Avatar experience, where they will see an avatar resembling themselves in a park setting.

Outcome Measures

Primary Outcome Measures

  1. Reduced Use of Drug Using Days [Study Day Visit; 30-day Follow-up Visit; 6-month Follow-up Visit.]

    The Virtual Reality Avatar experience will reduce drug using days.

  2. Increased Length of Abstinence [Study Day Visit; 30-day Follow-up Visit; 6-month Follow-up Visit.]

    The Virtual Reality Avatar experience will increase the length of abstinence periods.

  3. Increased (overall) Abstinence [Study Day Visit; 30-day Follow-up Visit; 6-month Follow-up Visit.]

    The Virtual Reality Avatar experience will increase abstinence.

Secondary Outcome Measures

  1. Future Self-identification [Study Day Visit; 30-day Follow-up Visit; 6-month Follow-up Visit.]

    The Virtual Reality Avatar experience will increase future self-identification.

  2. Future Time Perspective [Study Day Visit; 30-day Follow-up Visit; 6-month Follow-up Visit.]

    The Virtual Reality Avatar experience will increase future time perspective.

  3. Delayed Reward Preference [Study Day Visit; 30-day Follow-up Visit; 6-month Follow-up Visit.]

    The Virtual Reality Avatar experience will increase preference for delayed rewards.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

Overtly healthy men and women in early recovery (≥14 days and ≤ 6 months of drug abstinence).

At least 18 years old (no upper age limit) A single lapse event between the interview and study day is not exclusionary if participants endorse a continued commitment to recovery.

Outpatient only (post-inpatient/detox, and/or mutual-help involvement (e.g., 12-Step, SMART Recovery, Intensive Outpatient, or counseling).

Psychotropic drugs often prescribed for SUD-comorbid conditions or directly related to treatment and early recovery and/or mental health (e.g., anxiety medications, naltrexone) will be allowed and tracked as covariates.

Drug/alcohol abstinence ≥ 24 hours at the time of the study day visit. Able to understand/complete questionnaires and procedures in English.

Exclusion Criteria:

Unstable or significant medical disorders that may influence study outcomes or participant safety.

Less than 18 years old. A return to habitual drug use and/or heavy drinking after study enrollment. Delay discounting behavior at the interview corresponds to zero or total discounting, which makes data uninterpretable.

Current use of prescribed mu-opioid medication (e.g., methadone and buprenorphine) due to potential non-compliance and withdrawal effects.

History of smell or taste disorders, including any special sensitivities to volatile chemicals or chronic asthma.

Psychiatric conditions severe enough to compromise data integrity (e.g., motor disorders, schizophrenia/psychotic disorders, mania/bipolar disorders, or intellectual disorders affecting comprehension, as determined by the principal investigator.

Participants with highly unique physical features, including certain hairstyles or facial/neck/hand tattoos, due to difficulty modeling some visual features for creating lifelike avatars for the Virtual Reality group only, as determined by the principal investigator and virtual reality developers.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Indiana University School of Medicine - Goodman Hall Indianapolis Indiana United States 46202

Sponsors and Collaborators

  • Indiana University
  • National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Brandon G Oberlin, PhD, Indiana University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Brandon G. Oberlin, PhD, Assistant Professor, Indiana University
ClinicalTrials.gov Identifier:
NCT05835921
Other Study ID Numbers:
  • 1805574553; Aims 5-6
  • RENTS
  • 1R34DA055304-01
First Posted:
Apr 28, 2023
Last Update Posted:
Apr 28, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 28, 2023