Enhancing Prospective Thinking in Early Recovery

Alcohol Use Disorder Clinical Trial

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Official title:

Enhancing Prospective Thinking in Early Recovery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06302413
• Other study ID #: 1805574553; Aims 9-10
• Secondary ID: 1R01AA029396-01
• Status: Recruiting
• Phase: N/A
• Start date: February 15, 2024
• Est. completion date: July 31, 2027

Study information

• Verified date: March 2024
• Source: Indiana University
• Contact: Sarah Turo, BA
• Phone: 317-963-7220
• Email: sturo[@]iu.edu
• Is FDA regulated: No
• 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: July 31, 2027
• Est. primary completion date: July 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Use Disorder
• Alcoholism

Intervention

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

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

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.	Day 2-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.	Day 2-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.	Day 2-Study Day Visit; 30-day Follow-up Visit; 6-month Follow-up Visit.
Primary	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
Primary	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.
Primary	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.