Enhancing Prospective Thinking in Early Recovery (HOME)

NCT06302413 | Recruiting DMC FDA Device

• 2 other identifiers: 1805574553; Aims 9-101R01AA029396-01
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Alcohol Use Disorder

Outcome Measures

Primary Outcomes (6)

• 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.

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 Reality DEVICE

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

• 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
• 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
• Habitual drug use
• Mu-opioid drugs
• Smell/taste disorders
• Unstable psychiatric conditions
• Extravagant/elaborate face tattoos

Sponsors & Collaborators

• Indiana University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Indiana University School of Medicine - Goodman Hal

Indianapolis, Indiana, 46202, United States

RECRUITING

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Brandon G Oberlin, PhD

  Indiana University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Turo, BA

CONTACT

317-963-7220; sturo@iu.edu

Colton Lind, BS

CONTACT

317-963-2554; cmlind@iu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• 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

Study Record Dates

• First Submitted: February 21, 2024
• First Posted: March 8, 2024
• Study Start: February 15, 2024
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-03

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 (1)