NCT05835921

Brief Summary

The goal of this clinical trial is to use a novel virtual reality intervention to test for efficacy in reducing alcohol use and increasing abstinence, with concomitant increases in future self-identification, future time perspective, and delay-of-reward, in early recovering stimulant use disorder (SUD) 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 alcohol 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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 28, 2023

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

April 19, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 28, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

3.1 years

First QC Date

April 19, 2023

Last Update Submit

March 23, 2026

Conditions

Substance Use DisordersStimulant Use

Outcome Measures

Primary Outcomes (6)

  • Reduced Use of Drug Using Days

    The Virtual Reality Avatar experience will reduce drug using days.

    Study Day Visit; 30-day Follow-up Visit; 6-month Follow-up Visit.

  • Increased Length of Abstinence

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

    Study Day Visit; 30-day Follow-up Visit; 6-month Follow-up Visit.

  • Increased (overall) Abstinence

    The Virtual Reality Avatar experience will increase abstinence.

    Study Day Visit; 30-day Follow-up Visit; 6-month Follow-up Visit.

  • Future Self-identification

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

    Study Day Visit; 30-day Follow-up Visit; 6-month Follow-up Visit.

  • Future Time Perspective

    The Virtual Reality Avatar experience will increase future time perspective.

    Study Day Visit; 30-day Follow-up Visit; 6-month Follow-up Visit.

  • Delayed Reward Preference

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

    Study Day Visit; 30-day Follow-up Visit; 6-month Follow-up Visit.

Study Arms (2)

Virtual Reality

EXPERIMENTAL

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

Device: Virtual Reality

Treatment As Usual

PLACEBO COMPARATOR

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

Device: Virtual Reality

Interventions

Virtual RealityDEVICE

They will receive a Virtual Reality Park experience, which is an empty park with no avatars. They will then have a Virtual Reality Avatar experience, where they will see an avatar resembling themselves in a park setting.

Virtual Reality

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Abstinence between ≥14 days and ≤1 year
  • At least 18 years old
  • Verbal endorsement of commitment to recovery
  • Outpatient
  • Psychotropic drugs for SUD-comorbidity
  • Drug/alcohol abstinence ≥ 24 hours at the time of the study day visit
  • English comprehension

You may not qualify if:

  • Unstable medical disorders
  • Less than 18 years old
  • Habitual drug use
  • Mu-opioid drugs
  • Smell/taste disorders
  • Unstable psychiatric conditions
  • Extravagant/elaborate face tattoos

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indiana University School of Medicine - Goodman Hall

Indianapolis, Indiana, 46202, United States

RECRUITING

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Brandon G Oberlin, PhD

    Indiana University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Turo, MSW

CONTACT

317-963-7220sturo@iu.edu

Colton Lind, BS

CONTACT

317-963-2554cmlind@iu.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 19, 2023

First Posted

April 28, 2023

Study Start

March 28, 2023

Primary Completion

May 1, 2026

Study Completion

May 1, 2026

Last Updated

March 27, 2026

Record last verified: 2026-03

Locations

US(1)