An interventional study of Alcohol-targeted Brief Intervention-Medication Therapy Management and Standard medication counseling in Alcohol Drinking and Opioid Use, sponsored by University of Utah. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-12.
Sponsored by University of Utah · Not applicable, Interventional, and Prevention
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.
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.
925 studies on the registry are indexed under Alcohol Drinking; 172 are open to participants now.
This study's enrollment of 112 is close to the median of 108 across 802 interventional studies indexed under Alcohol Drinking.
Browse Alcohol Drinking studies →University of Utah is the lead sponsor of 969 studies on the registry; 178 are open to participants now.
Of its 107 completed or terminated interventional studies of FDA-regulated products, 62 (58%) have results posted.
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Exclusion Criteria:
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 (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
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 (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.
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.
Time frame: 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.
Time frame: 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.
| Milestone | Alcohol-targeted Brief Intervention-Medication Therapy Management | Standard Medication Counseling | Qualitative Interviews |
|---|---|---|---|
| Started | 22 | 22 | 68 |
| Completed | 22 | 22 | 68 |
| Not completed | 0 | 0 | 0 |
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.
| Participants | Alcohol-targeted Brief Intervention-Medication Therapy Management | Standard Medication Counseling |
|---|---|---|
| <=19% reduction in drinks per day | 11 | 12 |
| 20-24% reduction in drinks per day | 1 | 1 |
| 25-29% reduction in drinks per day | 1 | 2 |
| >=30% reduction in drinks per day | 9 | 7 |
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.
| Participants | Alcohol-targeted Brief Intervention-Medication Therapy Management | Standard Medication Counseling |
|---|---|---|
| <=10% reduction in morphine milligram equivalents | 12 | 17 |
| 11-19% reduction in morphine milligram equivalents | 1 | 0 |
| 20-24% reduction in morphine milligram equivalents | 1 | 0 |
| 25-29% reduction in morphine milligram equivalents | 1 | 1 |
| >=30% reduction in morphine milligram equivalents | 7 | 4 |
Collected over This was a minimal risk study and as such no adverse events were collected.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Alcohol-targeted Brief Intervention-Medication Therapy Management | — | — | — |
| Standard Medication Counseling | — | — | — |
| Age, Categorical(Participants) | Alcohol-targeted Brief Intervention-Medication Therapy Management | Standard Medication Counseling | Qualitative Interviews | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 14 | 10 | 68 | 92 |
| >=65 years | 8 | 12 | 0 | 20 |
| Sex/Gender, Customized(Participants) | Alcohol-targeted Brief Intervention-Medication Therapy Management | Standard Medication Counseling | Qualitative Interviews | Total |
|---|---|---|---|---|
| Males | 14 | 15 | 26 | 55 |
| Females | 8 | 17 | 36 | 61 |
| Unknown | 0 | 0 | 6 | 6 |
| Ethnicity (NIH/OMB)(Participants) | Alcohol-targeted Brief Intervention-Medication Therapy Management | Standard Medication Counseling | Qualitative Interviews | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 1 | 0 | 1 |
| Not Hispanic or Latino | 22 | 21 | 0 | 43 |
| Unknown or Not Reported | 0 | 0 | 68 | 68 |
| Race (NIH/OMB)(Participants) | Alcohol-targeted Brief Intervention-Medication Therapy Management | Standard Medication Counseling | Qualitative Interviews | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 2 | 0 | 0 | 2 |
| White | 20 | 22 | 0 | 42 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 68 | 68 |
| Region of Enrollment(participants) | Alcohol-targeted Brief Intervention-Medication Therapy Management | Standard Medication Counseling | Qualitative Interviews | Total |
|---|---|---|---|---|
| United States | 22 | 22 | 68 | 112 |
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University of Utah