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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05835921
Other study ID # 1805574553; Aims 5-6
Secondary ID RENTS1R34DA05530
Status Recruiting
Phase N/A
First received
Last updated
Start date March 28, 2023
Est. completion date May 1, 2026

Study information

Verified date February 2024
Source Indiana University
Contact Sarah Turo, BA
Phone 3179637220
Email sturo@iu.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this clinical trial is to use a novel virtual reality intervention to test for efficacy in reducing stimulant use and increasing abstinence, with concomitant increases in future self-identification, future time perspective, and delay-of-reward, in early recovering stimulant use disorder (StUD) 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 stimulant drug 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 88
Est. completion date May 1, 2026
Est. primary completion date May 1, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Abstinence between =14 days and =1 year - At least 18 years old - 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 - Less than 18 years old - Habitual drug use - Mu-opioid drugs - Smell/taste disorders - Unstable psychiatric conditions - Extravagant/elaborate face tattoos

Study Design


Intervention

Device:
Virtual Reality
Both groups will receive a Virtual Reality Park experience, which is an empty park with no avatars. Only the experimental group will have a Virtual Reality Avatar experience, where they will see an avatar resembling themselves in a park setting.

Locations

Country Name City State
United States Indiana University School of Medicine - Goodman Hall Indianapolis Indiana

Sponsors (2)

Lead Sponsor Collaborator
Indiana University National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Reduced Use of Drug Using Days The Virtual Reality Avatar experience will reduce drug using days. Study Day Visit; 30-day Follow-up Visit; 6-month Follow-up Visit.
Primary Increased Length of Abstinence The Virtual Reality Avatar experience will increase the length of abstinence periods. Study Day Visit; 30-day Follow-up Visit; 6-month Follow-up Visit.
Primary Increased (overall) Abstinence The Virtual Reality Avatar experience will increase abstinence. Study Day Visit; 30-day Follow-up Visit; 6-month Follow-up Visit.
Primary Future Self-identification The Virtual Reality Avatar experience will increase future self-identification. Study Day Visit; 30-day Follow-up Visit; 6-month Follow-up Visit.
Primary Future Time Perspective The Virtual Reality Avatar experience will increase future time perspective. Study Day Visit; 30-day Follow-up Visit; 6-month Follow-up Visit.
Primary Delayed Reward Preference The Virtual Reality Avatar experience will increase preference for delayed rewards. Study Day Visit; 30-day Follow-up Visit; 6-month Follow-up Visit.
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