Brief Digitally-Enhanced Intervention for Reducing Alcohol Use During MOUD

Recruiting now · Not applicable

Conditions studied: Opioid Use Disorder

In brief

The goal of this clinical trial is to reduce heavy drinking and enhance medication for opioid use disorder (MOUD) outcomes in individuals receiving MOUD. The main questions it aims to answer are: * Does the brief, digitally-enhanced, virtual psychotherapeutic intervention, called Managing Physical Reactions to Overwhelming Emotions (IMPROVE), impact daily alcohol use and MOUD adherence? * Does the intervention change self-report and physiological responses to intolerance to uncertainty and anxiety sensitivity? Researchers will compare IMPROVE to a control intervention (health education treatment) to see if IMPROVE impacts daily alcohol use and MOUD adherence. Participants will: * Complete a baseline electroencephalography (EEG) and self-report questionnaires. * Complete three one-hour intervention sessions (IMPROVE or control) each one week a part. * Complete a post-intervention EEG and self-report questionnaires. * Complete five ecological momentary assessment (EMA) surveys a day for 21 days. * Complete self-report questionnaires one-month after their last intervention session.

Key facts

Study ID: NCT06718491
Run by: Ohio State University
People needed: 80
Starts: 2025-08-01
Expected to finish: 2027-07-01
Last updated by the study team: 2026-06-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Enrolled in outpatient medication for opioid use disorder (MOUD) program (within the past month)
Heavy alcohol user defined using the National Institute on Alcohol Abuse and Alcoholism (NIAAA) criteria (i.e., consume 8+/15+ drinks per week [women/men] with at least two binge episodes [4/5+ drinks for women/men in a 2 hour period] in the past month)
Elevated psychological distress defined as a total score of > 12 on the Kessler Psychological Distress Scale (K10; 0 to 40 range)
18 years of age or older
Can read and comprehend English

You may not qualify if…

Do not pass the informed decision-making capacity screener, suggesting cognitive impairment or an inability to provide informed consent
Presence of a psychiatric or medical condition that would prevent them from providing informed consent or participating in the treatments (e.g., psychosis, mania, acute intoxication)
Current comorbid moderate to severe substance use disorder other than alcohol and opioids
Limited or no access to a smart phone that is compatible with the mobile application
Participation in Phase One
Possibility of being pregnant (by self-report)
Current suicidal or homicidal intent indicating a need for immediate hospitalization or treatment as determined by clinical interviewer

Where it is running

Ohio State University — Columbus, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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