Co-Use of Opioid Medications and Alcohol Prevention Study
NCT05599672 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 112
Last updated 2025-09-12
Summary
Previous research, including that of this team, shows that a significant portion of those regularly using opioids-particularly filling opioids at community pharmacies-also are involved in the co-use of alcohol. This study proposes to adapt a previously developed intervention for opioid medication misuse; test its acceptability, feasibility, and preliminary efficacy; and identify barriers and facilitators to large-scale research and system-level implementation. Results of this study will directly inform a fully-powered subsequent multisite trial.
Conditions
- Alcohol Drinking
- Opioid Use
Interventions
- BEHAVIORAL
-
Alcohol-targeted Brief Intervention-Medication Therapy Management
Alcohol-targeted Brief Intervention-Medication Therapy Management (ABI-MTM) intervention is a pharmacy-based medication management intervention, combined with Screening, Brief Intervention, and Referral to Treatment. ABI-MTM includes 5 core elements. A common duration for medication counseling in outpatient pharmacies a single 30-45 minute session. These include a medication review, a personal medication record, a medication action plan, a brief motivational intervention, and documentation and follow up.
- BEHAVIORAL
-
Standard medication counseling
Standard Medication Counseling (SMC) will be the treatment as usual condition in this study and was chosen/developed following Gold et al.'s guide for selecting control conditions in behavioral intervention studies. For the first component, all SMC participants will receive a single 5-10 minute medication information/counseling session delivered by a pharmacist, other than the study pharmacist, that possesses a similar level of education and professional licensing. The content of this session follows federal and state pharmacy requirements requiring pharmacists to: (1) offer counseling, (2) document counseling was offered, (3) offer a counseling process for patients not present (not applicable to this study given all patients must screen in person), and (4) discuss generic substitution. Following this session, in the second SMC component, participants will be emailed/mailed (according to participant preference) safety information about co-use of alcohol and opioids.
Sponsors & Collaborators
-
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
collaborator NIH - lead OTHER
Principal Investigators
-
Gerald Cochran · University of Utah
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-05-01
- Primary Completion
- 2024-08-19
- Completion
- 2024-08-19
Countries
- United States
Study Locations
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