Digital intervention to reduce alcohol use in patients receiving opioid treatment
Brief Digitally-Enhanced Intervention for Managing Emotional Pain and Reducing Alcohol Use During Medication for OUD
This study tests a digital program designed to help people in opioid treatment reduce their heavy drinking and improve their overall health.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ohio State University Academic / other |
| Locations | 1 site (Columbus, Ohio) |
| Trial ID | NCT06718491 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults enrolled in outpatient MOUD programs who are heavy alcohol users and experience elevated psychological distress.
Not a fit: Patients with cognitive impairments or severe psychiatric conditions that prevent informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce alcohol use and improve treatment adherence for patients with opioid use disorder.
How similar studies have performed: Other studies have shown promise in using digital interventions for substance use disorders, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Columbus, Ohio
- Ohio State University — Columbus, Ohio, United States (Recruiting)
Study contacts
- Study coordinator: Stephanie Gorka, PhD
- Email: stephanie.gorka@osumc.edu
- Phone: 614-366-1027
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.