NCT06718491 Brief Digitally-Enhanced Intervention for Reducing Alcohol Use During MOUD
| NCT ID | NCT06718491 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ohio State University |
| Condition | Opioid Use Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-08-01 |
| Primary Completion | 2027-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2025-08-01 with a primary completion date of 2027-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06718491 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Opioid Use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06718491 currently recruiting?
Yes, NCT06718491 is actively recruiting participants. Contact the research team at stephanie.gorka@osumc.edu for enrollment information.
Where is the NCT06718491 trial being conducted?
This trial is being conducted at Columbus, United States.
Who is sponsoring the NCT06718491 clinical trial?
NCT06718491 is sponsored by Ohio State University. The trial plans to enroll 80 participants.