Enhancing Prospective Thinking in Early Recovery (HOME)

Indiana University

Status: Enrolling

Conditions: Alcohol Use Disorder

Treatments: Device: Virtual Reality

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06302413

1R01AA029396-01 (U.S. NIH Grant/Contract)

1805574553 Aims 9-10;

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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500 participants in 2 patient groups, including a placebo group

Virtual Reality

Experimental group

Description:

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

Treatment:

Device: Virtual Reality

Device: Virtual Reality

Treatment As Usual

Placebo Comparator group

Description:

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

Treatment:

Device: Virtual Reality

Device: Virtual Reality