Clinical trial NCT05599672: Co-Use of Opioid Medications and Alcohol Prevention Study
Official title: Co-Use of Opioid Medications and Alcohol Prevention Study (COAPS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Drinking
Opioid Use
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2022-10-31
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study will test the Adapt/manualize an Alcohol-targeted Brief Intervention-Medication Therapy Management (ABI-MTM) intervention compared to standard medication counseling
Primary purpose: PREVENTION

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. 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.

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

Primary outcomes:
measure: Alcohol use reductions
timeFrame: 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.
measure: Non opioid medication alternative
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: University of Tennessee College of Medicine
state: Tennessee
Study officials:
References: