Co-Use of Opioid Medications and Alcohol Prevention Study

NCT ID: NCT05599672

Last Updated: 2025-09-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2024-08-19

Brief 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.

Detailed Description

Co-use of alcohol and opioid medications is known to be a serious health/safety hazard-yet persists despite these negative ramifications. With limited information available within peer-reviewed literature, large-scale system and clinical research have demonstrated 24-38% of those with alcohol use disorders also have an opioid addiction, with rates of past 30-day opioid medication misuse among those seeking alcohol treatment as high as 68%. Research from this group has shown that among community pharmacy patients receiving opioid medications for pain management, approximately 20-30% are engaged in co-use of alcohol. Community pharmacy is a highly valuable but underutilized resource and setting for identification and intervention to address the US opioid epidemic. The investigators propose to adapt, manualize, and test the acceptability, feasibility, and preliminary efficacy of an Alcohol-targeted Brief Intervention-Medication Therapy Management (ABI-MTM) intervention with community pharmacy patients. ABI-MTM will be a pharmacy-based medication management intervention, combined with Screening, Brief Intervention, and Referral to treatment that will target: (1) alcohol use elimination during opioid treatment OR (2) non-opioid pain management substitution (in consultation with the prescriber). The investigators will conduct a small-scale trial in 3 community pharmacy locations wherein the investigators will randomize patients with heavy alcohol use and with non-heavy alcohol use (1-to-1 ratio) to ABI-MTM (n=20) or standard medication counseling (SMC, n=20). Results will demonstrate intervention acceptability, feasibility, and preliminary efficacy. This study will also work to identify pharmacy system and practice-level barriers and facilitators for universal alcohol screening and intervention among opioid recipients. This study will also work to identify pharmacy system and practice-level barriers and facilitators for universal alcohol screening and intervention among opioid recipients. The investigators will develop a mixed methods assessment guide to interview pharmacy technicians (N=20), pharmacists (N=20), and corporate leaders (N=20). Interviews will assess perceptions towards screening/intervention, internal organizational challenges, and processes related to ABI-MTM implementation for large-scale research and practice. Altogether, results of this study will provide critical insights, foundational data, and strategies for executing a powered trial and possible future system/practice-level implementation.

Conditions

Alcohol Drinking; Opioid Use

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Alcohol-targeted Brief Intervention-Medication Therapy Management

Intervention Type: BEHAVIORAL

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.

Standard medication counseling

Standard Medication Counseling (SMC) (1) will offer counseling, (2) document counseling was offered, (3) offer a counseling process for patients not present, 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

Group Type: ACTIVE_COMPARATOR

Standard medication counseling

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• English speaking
• ≥18 years
• Not receiving cancer treatment
• Current alcohol use
• Prescribed an opioid medication

Exclusion Criteria

• SA 2 exclusion
• Are pregnant
• Cannot provide collateral contact information for ≥2 persons
• Do not have a reliable land line or mobile phone to be contacted by study staff
• Are filling only buprenorphine
• Plan to leave the area for an extended period of time in the next 3-months, or
• Have experienced a psychotic and/or manic episode in the last 30 days

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Jerry Cochran

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gerald Cochran

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

University of Tennessee College of Medicine

Nashville, Tennessee, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1R34AA029447-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

00152822

Identifier Type: -

Identifier Source: org_study_id