Co-Use of Opioid Medications and Alcohol Prevention Study

Opioid Use Clinical Trial

— COAPS  

Official title:

Co-Use of Opioid Medications and Alcohol Prevention Study (COAPS)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05599672
• Other study ID #: 00152822
• Secondary ID: 1R34AA029447-01A
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: April 30, 2025

Study information

• Verified date: May 2024
• Source: University of Utah
• Contact: Gerald Cochran, PhD
• Phone: 801-213-0654
• Email: jerry.cochran[@]hsc.utah.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Opioid Use

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Tennessee College of Medicine	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
University of Utah	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	Non opioid medication alternative	The investigators will use the Treatment Services Review 6 to assess if the patients change opioid medication to non opioid pain medications. 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.