Digital intervention to reduce alcohol use in patients receiving opioid treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to reduce heavy alcohol consumption and improve outcomes for individuals undergoing medication for opioid use disorder (MOUD). Participants will engage in a brief, digitally-enhanced intervention called IMPROVE, which focuses on managing emotional reactions, and will be compared to a control group receiving health education. The study will assess the impact of the intervention on daily alcohol use and adherence to MOUD through self-reports and physiological measures, including electroencephalography (EEG). Participants will complete multiple assessments throughout the study to evaluate changes in their alcohol use and psychological responses.

Why it matters

Who can join: the full rules

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

Where it's running

• Ohio State University
  Columbus, Ohio, United States Recruiting

Study contacts

• Study coordinator: Stephanie Gorka, PhD
• Email: stephanie.gorka@osumc.edu
• Phone: 614-366-1027

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.