Brief Digitally-Enhanced Intervention for Reducing Alcohol Use During MOUD (NCT06718491) | Clinical Trial Compass
RecruitingNot Applicable
Brief Digitally-Enhanced Intervention for Reducing Alcohol Use During MOUD
United States80 participantsStarted 2025-08-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Alcohol Use
Timeframe: Change from baseline to post-treatment (week 4)
2
Startle eyeblink potentiation during unpredictable threat
Timeframe: Change from baseline to post-treatment (week 4)
3
Self-reported Intolerance of Uncertainty
Timeframe: Change from baseline to post-treatment (week 4)
4
Late positive potential when viewing anxiety sensitivity evoking images
Timeframe: Change from baseline to post-treatment (week 4)
5
Self-reported Anxiety Sensitivity
Timeframe: Change from baseline to post-treatment (week 4)