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Brief Digitally-Enhanced Intervention for Reducing Alcohol Use During MOUD

RecruitingNAAges 18 Years - anyAllOhio State University
NCT06718491 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 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
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What it tests

  • Managing Physical Reactions to Overwhelming Emotions (IMPROVE)
  • Health Education Training (HET)
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Where

1 site
Ohio State University
Columbus, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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