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Enhancing Prospective Thinking in Early Recovery

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 alcohol use disorder (AUD) 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.

Study Overview

• Status: Recruiting
• Conditions: Alcohol Use Disorder
• Intervention / Treatment: Device: Virtual Reality; Device: Virtual Reality

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sarah Turo, BA; Phone Number: 317-963-7220; Email: sturo@iu.edu
• Study Contact Backup: Name: Colton Lind, BS; Phone Number: 317-963-2554; Email: cmlind@iu.edu

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Recruiting
      • Indiana University School of Medicine - Goodman Hal
      • Principal Investigator: Brandon G Oberlin, PhD
      • Contact: Sarah Turo, BA; Phone Number: 317-963-7220; Email: sturo@iu.edu

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Abstinence between ≥14 days and ≤1 year
• 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

Exclusion Criteria:

• Unstable medical disorders
• Habitual drug use
• Mu-opioid drugs
• 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 Park Virtual Reality Avatar	Device: Virtual Reality; 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.; Device: Virtual Reality; They will receive a Virtual Reality Park experience, which is an empty park with no avatars.
Placebo Comparator: Treatment As Usual; Participants in this arm will receive the following interventions: Virtual Reality Park	Device: Virtual Reality; 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.; Device: Virtual Reality; They will receive a Virtual Reality Park experience, which is an empty park with no avatars.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduced Use of Drug Using Days	The Virtual Reality Avatar experience will reduce drug using days.	Day 2-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.	Day 2-Study Day Visit; 30-day Follow-up Visit; 6-month Follow-up Visit.
Increased (overall) Abstinence	The Virtual Reality Avatar experience will increase abstinence.	Day 2-Study Day Visit; 30-day Follow-up Visit; 6-month Follow-up Visit.
Future Self-identification with Future Self Continuity Questionnaire	The Virtual Reality Avatar experience will increase future self-identification.	Day 2-Study Day Visit; 30-day Follow-up Visit; 6-month Follow-up Visit
Future Time Perspective with the Delayed Discounting Behavioral Task and Future Self Continuity Questionnaire	The Virtual Reality Avatar experience will increase future time perspective.	Day 2-Study Day Visit; 30-day Follow-up Visit; 6-month Follow-up Visit.
Delayed Reward Preference with the Delayed Discounting Behavioral Task	The Virtual Reality Avatar experience will increase preference for delayed rewards.	Day 2-Study Day Visit; 30-day Follow-up Visit; 6-month Follow-up Visit.

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Investigators: Principal Investigator: Brandon G Oberlin, PhD, Indiana University

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2024
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027

Study Registration Dates

• First Submitted: February 21, 2024
• First Submitted That Met QC Criteria: March 4, 2024
• First Posted (Actual): March 8, 2024

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Alcoholism
• Other Study ID Numbers: 1805574553; Aims 9-10; 1R01AA029396-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Pre-determined participant 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