Alcohol DrinkingCOAPSNCT05599672
Co-Use of Opioid Medications and Alcohol Prevention Study
A study testing Alcohol-targeted Brief Intervention-Medication Therapy Management and Standard medication counseling in people with Alcohol Drinking and Opioid Use, run by University of Utah at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Drinking, Opioid Use
- What is being tested?
- Alcohol-targeted Brief Intervention-Medication Therapy Management and Standard medication counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2023to 19 Aug 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English speaking
- ≥18 years
- Not receiving cancer treatment
- Current alcohol use
- Prescribed an opioid medication
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Tennessee College of Medicine
Nashville, Tennessee, 38103
About this study
Official title: Co-Use of Opioid Medications and Alcohol Prevention Study (COAPS)
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.
Read the 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
- Being tested
- Alcohol-targeted Brief Intervention-Medication Therapy Management, Standard medication counseling
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alcohol-targeted Brief Intervention-Medication Therapy ManagementBehavioural
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 counselingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Behavioral: Standard medication counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2022
- Study start1 May 2023
- Primary completion19 Aug 2024
- Study completion19 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alcohol DrinkingStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Jerry Cochran, University of Utah
- Investigators
- Gerald Cochran, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05599672
- Sponsor's protocol ID
- 00152822
- Other IDs
- 1R34AA029447-01A1
- Acronym
- COAPS
- Status last verified
- Aug 2025
- First submitted
- 26 Oct 2022
- Last updated
- 12 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Co-Use of Opioid Medications and Alcohol Prevention Study (COAPS)
- ClinicalTrials.gov ID
- NCT05599672
- Acronym / sponsor ID
- COAPS / 00152822
- Conditions
- Alcohol Drinking, Opioid Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 1 May 2023 (actual)
- Primary completion
- 19 Aug 2024 (actual)
- Study completion
- 19 Aug 2024 (actual)
- First posted
- 31 Oct 2022 (actual)
- Results
- Posted 12 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Alcohol-targeted Brief Intervention-Medication Therapy Management | Experimental | Behavioral: Alcohol-targeted Brief Intervention-Medication Therapy ManagementAlcohol-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 |
| Standard medication counseling | Active comparator | Behavioral: Standard medication counselingStandard 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- English speaking
- ≥18 years
- Not receiving cancer treatment
- Current alcohol use
- Prescribed an opioid medication
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alcohol-targeted Brief Intervention-Medication Therapy ManagementAlcohol-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. | Behavioural | Alcohol-targeted Brief Intervention-Medication Therapy Management |
| Standard medication counselingStandard 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. | Behavioural | Standard medication counseling |
Primary outcome
Alcohol Use Reductions
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.
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.
Opioid Medication Use
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerald Cochran principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alcohol-targeted Brief Intervention-Medication Therapy Management and Standard medication counseling in people with Alcohol Drinking and Opioid Use, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alcohol Use Reductions (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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.