Enhancing Prospective Thinking in Early Recovery (HOME)

NCT ID: NCT06302413

Last Updated: 2025-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-15

Study Completion Date

2027-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Alcohol Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants
All study participants are randomly assigned to a group prior to study enrollment. Participants will not be made aware of their group assignment.

Study Groups

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Virtual Reality

Participants in this arm will receive the following interventions:

Virtual Reality Park Virtual Reality Avatar

Group Type EXPERIMENTAL

Virtual Reality

Intervention Type 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.

Treatment As Usual

Participants in this arm will receive the following interventions:

Virtual Reality Park

Group Type PLACEBO_COMPARATOR

Virtual Reality

Intervention Type DEVICE

They will receive a Virtual Reality Park experience, which is an empty park with no avatars.

Interventions

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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.

Intervention Type DEVICE

Virtual Reality

They will receive a Virtual Reality Park experience, which is an empty park with no avatars.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role collaborator

Indiana University

OTHER

Sponsor Role lead

Responsible Party

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Brandon G. Oberlin, PhD

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Brandon G Oberlin, PhD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

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Indiana University School of Medicine - Goodman Hal

Indianapolis, Indiana, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Sarah Turo, BA

Role: CONTACT

317-963-7220

Colton Lind, BS

Role: CONTACT

317-963-2554

Facility Contacts

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Sarah Turo, BA

Role: primary

317-963-7220

Other Identifiers

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1R01AA029396-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1805574553; Aims 9-10

Identifier Type: -

Identifier Source: org_study_id

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