Clinical trial NCT06302413: Enhancing Prospective Thinking in Early Recovery (HOME)
Official title: Enhancing Prospective Thinking in Early Recovery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alcohol Use Disorder
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2024-03-08
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Reduced Use of Drug Using Days
timeFrame: Day 2-Study Day Visit; 30-day Follow-up Visit; 6-month Follow-up Visit
measure: Increased Length of Abstinence
timeFrame: Day 2-Study Day Visit; 30-day Follow-up Visit; 6-month Follow-up Visit.
measure: Increased (overall) Abstinence
timeFrame: Day 2-Study Day Visit; 30-day Follow-up Visit; 6-month Follow-up Visit.
measure: Future Self-identification with Future Self Continuity Questionnaire
timeFrame: Day 2-Study Day Visit; 30-day Follow-up Visit; 6-month Follow-up Visit
measure: Future Time Perspective with the Delayed Discounting Behavioral Task and Future Self Continuity Questionnaire
timeFrame: Day 2-Study Day Visit; 30-day Follow-up Visit; 6-month Follow-up Visit.
measure: Delayed Reward Preference with the Delayed Discounting Behavioral Task
timeFrame: Day 2-Study Day Visit; 30-day Follow-up Visit; 6-month Follow-up Visit.
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University School of Medicine - Goodman Hal
state: Indiana
Study officials:
affiliation: Indiana University
name: Brandon G Oberlin, PhD
role: PRINCIPAL_INVESTIGATOR
References: