Brief Digitally-Enhanced Intervention for Reducing Alcohol Use During MOUD (NCT06718491)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (5 items) and avoid the listed exclusions (8 items).
Location: Ohio State University — Columbus, Ohio
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- 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
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Ohio State University — Columbus, Ohio
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.