Co-Use of Opioid Medications and Alcohol Prevention Study

NCT05599672 | Completed Results

• 2 other identifiers: 001528221R34AA029447-01A1
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Drinking; Opioid Use

Outcome Measures

Primary Outcomes (2)

• Alcohol Use Reductions

  The investigators will use the Timeline Follow Back to assess alcohol use reductions. This measure is a calendar based assessment that captures a continuous number (counts) of days of substance use. This quantitative measure is both valid and reliable.

  3 Months. Changes in alcohol use will be assessed by comparing baseline to month 2. Changes in alcohol use will also be assessed by comparing month 2 to month 3.

• Opioid Medication Use

  The investigators will use the Treatment Services Review 6 to assess if the patients decrease their medication use. This measure is a calendar based assessment that captures a continuous number (counts) of days of substance use. This quantitative measure is both valid and reliable.

  3 Months. Changes in medication use will be assessed by comparing baseline to month 2. Changes in medication use will also be assessed by comparing month 2 to month 3.

Study Arms (2)

Alcohol-targeted Brief Intervention-Medication Therapy Management

EXPERIMENTAL

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

Behavioral: Alcohol-targeted Brief Intervention-Medication Therapy Management

Standard medication counseling

ACTIVE COMPARATOR

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

Behavioral: Standard medication counseling

Interventions

Alcohol-targeted Brief Intervention-Medication Therapy Management 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.

Alcohol-targeted Brief Intervention-Medication Therapy Management

Standard medication counseling 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.

Standard medication counseling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

University of Tennessee College of Medicine

Nashville, Tennessee, 38103, United States

Location

MeSH Terms

Conditions

Alcohol Drinking

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Results Point of Contact

• Title: Gerald (Jerry) Cochran, PhD
• Organization: University of Utah

jerry.cochran@hsc.utah.edu

801-213-0654

Study Officials

• Gerald Cochran

  University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The assessor is blinded to the intervention condition.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: This study will test the Adapt/manualize an Alcohol-targeted Brief Intervention-Medication Therapy Management (ABI-MTM) intervention compared to standard medication counseling

Study Record Dates

• First Submitted: October 26, 2022
• First Posted: October 31, 2022
• Study Start: May 1, 2023
• Primary Completion: August 19, 2024
• Study Completion: August 19, 2024
• Last Updated: September 12, 2025
• Results First Posted: September 12, 2025

Record last verified: 2025-08

Locations

US (1)