Brief Intervention for Opioid Use Disorder with Alcohol Consumption

(COAPS Trial)

Overseen By Kristi Carlston, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Utah

Must be taking: Opioids

Must not be taking: Buprenorphine

Disqualifiers: Pregnancy, Psychotic episode, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to assist individuals who use both opioids and alcohol. It tests an intervention that combines medication management with a brief counseling session, known as Alcohol-targeted Brief Intervention-Medication Therapy Management, to evaluate its effectiveness in a pharmacy setting. The trial also compares this method to standard medication counseling. It suits English-speaking individuals who currently use alcohol and have a prescription for opioid medication. As an unphased trial, this study allows participants to contribute to innovative research that could enhance future treatment options for others.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue your prescribed opioid medication, as the study involves participants who are currently using opioids.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the Alcohol-targeted Brief Intervention-Medication Therapy Management (ABI-MTM) is under study to assist individuals who use both opioids and alcohol. This pharmacy-based program combines medication management with brief conversations and referrals to other treatments.

In past studies, similar programs have been tested for safety and effectiveness. These studies often assess participants' responses to the treatment and monitor for any side effects or issues. For the ABI-MTM, detailed information about specific side effects is limited. However, these programs are generally well-tolerated, focusing on counseling and education rather than introducing new or experimental drugs.

This trial is in the "Not Applicable" phase, concentrating on the practicality and acceptability of the treatment, indicating it is still early in the testing process. Early trials typically focus on safety, ensuring treatments are safe for broader use as they progress.

For those considering joining the trial, it is reassuring that programs like these aim to safely manage the use of both alcohol and opioids without introducing new medications. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Alcohol-targeted Brief Intervention-Medication Therapy Management (ABI-MTM) because it addresses both opioid use disorder and alcohol consumption simultaneously, which is unique compared to standard treatments that typically focus on only one substance at a time. This pharmacy-based approach combines medication management with Screening, Brief Intervention, and Referral to Treatment (SBIRT), offering a holistic care model that isn't standard in current treatments. By integrating these components, ABI-MTM has the potential to improve patient outcomes by addressing the complex interplay between alcohol and opioid use, which is often overlooked in traditional therapies.

What evidence suggests that this trial's treatments could be effective for opioid use disorder with alcohol consumption?

Research shows that about 20-30% of people who obtain opioid medications from pharmacies also engage in risky alcohol consumption. In this trial, participants may receive the Alcohol-targeted Brief Intervention-Medication Therapy Management (ABI-MTM), which combines medication management with education and support to reduce risky behaviors. A previous study tested a similar program and showed promising results in reducing the combined use of alcohol and opioids. Participants in ABI-MTM had better outcomes than those who only received standard medication advice. These early findings suggest that ABI-MTM could effectively help people who use both alcohol and opioids. Another group in this trial will receive Standard Medication Counseling, which includes counseling and safety information about the co-use of alcohol and opioids. ^{2 3 5 6 7}

Who Is on the Research Team?

Gerald Cochran

Principal Investigator

University of Utah

Are You a Good Fit for This Trial?

This trial is for English-speaking adults over 18 who currently use alcohol and are prescribed opioids, but not for cancer treatment. They must have a reliable phone and stay in the area for the next 3 months. It's not for those using only buprenorphine, pregnant individuals, anyone planning to leave the area soon, or those with recent psychotic/manic episodes.

Inclusion Criteria

I am currently taking prescribed opioid medication.

English speaking

I am not currently undergoing any cancer treatment.

Exclusion Criteria

Are filling only buprenorphine

SA 2 exclusion

Are pregnant

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the ABI-MTM intervention or standard medication counseling

3 months

Regular visits at community pharmacies

Follow-up

Participants are monitored for changes in alcohol and medication use

1 month

What Are the Treatments Tested in This Trial?

Interventions

• Alcohol-targeted Brief Intervention-Medication Therapy Management
• Standard medication counseling

Trial Overview The study is testing an intervention adapted from one designed to address opioid misuse. Participants will receive either Alcohol-targeted Brief Intervention-Medication Therapy Management or standard medication counseling to prevent co-use of opioids and alcohol.

How Is the Trial Designed?

Group I: Alcohol-targeted Brief Intervention-Medication Therapy Management Experimental Treatment 1 Intervention

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

Group II: Standard medication counseling Active Control 1 Intervention

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

Alcohol-targeted Brief Intervention-Medication Therapy Management is already approved in United States, European Union for the following indications:

Approved in United States as Vivitrol for:

• Alcohol dependence
• Opioid dependence

Approved in European Union as Naltrexone for:

• Alcohol dependence
• Opioid dependence

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Published Research Related to This Trial

In a study of 603 participants from the COMBINE Study, family history of alcoholism (FHA) was linked to increased alcohol consumption per drinking occasion, indicating that individuals with a stronger FHA may drink more when they do drink.

While naltrexone showed a significant effect on reducing heavy drinking days over time, the study found that FHA did not significantly influence the effectiveness of naltrexone, suggesting that other factors may be more important in determining treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does family history of alcoholism moderate naltrexone's effects on alcohol use? Capone, C., Kahler, CW., Swift, RM., et al.[2019]

The study found that 44% of patients with opioid or cocaine dependence also had problematic alcohol use, highlighting the need for targeted interventions in this population.

Screening for alcohol use with the AUDIT and providing brief interventions led to significant reductions in alcohol consumption over 3 and 9 months, although no significant differences were found between the treatment groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alcohol-related brief intervention in patients treated for opiate or cocaine dependence: a randomized controlled study. Feldman, N., Chatton, A., Khan, R., et al.[2021]

A systematic review of 49 trials found that only 14% of studies on naltrexone for alcohol dependence had high adherence assurance, which may explain the variability in treatment efficacy observed.

The study revealed a significant correlation between adherence levels and treatment outcomes, suggesting that improving adherence monitoring could enhance the effectiveness of naltrexone in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence monitoring in naltrexone pharmacotherapy trials: a systematic review. Swift, R., Oslin, DW., Alexander, M., et al.[2022]

In a study involving 302 participants with cocaine dependence and a history of opioid dependence, buprenorphine + naloxone (BUP) combined with extended-release injectable naltrexone (XR-NTX) showed a significant reduction in cocaine use for those receiving 16 mg/day of BUP compared to placebo, indicating its potential effectiveness in this population.

However, no significant differences were observed in the primary outcome for the 4 mg/day BUP group compared to placebo, suggesting that higher doses may be necessary for efficacy, while adherence, retention, and adverse events were similar across all groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Buprenorphine + naloxone plus naltrexone for the treatment of cocaine dependence: the Cocaine Use Reduction with Buprenorphine (CURB) study. Ling, W., Hillhouse, MP., Saxon, AJ., et al.[2018]

Among individuals with opioid use disorder (OUD), those with co-occurring alcohol use disorder (AUD) were 25% less likely to receive medication treatments like buprenorphine or methadone, indicating a significant gap in treatment access for this population.

Buprenorphine and methadone were associated with the highest treatment retention rates, regardless of the severity of OUD or AUD, suggesting these medications are effective options but are under-prescribed for individuals with co-occurring disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An examination between treatment type and treatment retention in persons with opioid and co-occurring alcohol use disorders. Mintz, CM., Presnall, NJ., Xu, KY., et al.[2022]

In a study of 412 opioid agonist patients, alcohol screening was found to be feasible, with 93% of buprenorphine patients in a primary care clinic completing screenings, although only 3% showed signs of alcohol use disorder.

Focus group discussions with healthcare providers revealed that while screening is possible, successful implementation depends on addressing various barriers, including the need for physician training and changes in clinic workflows.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alcohol Screening among Opioid Agonist Patients in a Primary Care Clinic and an Opioid Treatment Program. Klimas, J., Muench, J., Wiest, K., et al.[2018]

A single brief intervention delivered by clinicians significantly reduced problem alcohol and illicit substance use in a cohort of 465 opiate-dependent patients maintained on methadone, with results sustained at a three-month follow-up.

The intervention group showed a lower global risk score for substance use compared to the control group, indicating the effectiveness of the brief intervention in improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening and Brief Interventions for Illicit Drug Use and Alcohol Use in Methadone Maintained Opiate-Dependent Patients: Results of a Pilot Cluster Randomized Controlled Trial Feasibility Study. Darker, CD., Sweeney, B., Keenan, E., et al.[2019]

In a study involving 132 heroin-dependent patients undergoing naltrexone treatment, there was a significant increase in alcohol consumption observed in both groups evaluated.

The increase in alcohol consumption was particularly pronounced in patients with a history of alcohol abuse prior to their opiate dependence, suggesting a potential risk factor for increased drinking during naltrexone treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Alcohol consumption in opioid-dependence patients in treatment with naltrexone]. Ochoa Mangado, E., Arias Horcajadas, F.[2013]

Alcohol misuse is prevalent among individuals receiving treatment for opioid use disorder, leading to increased health risks and complications.

Current research lacks comprehensive strategies for managing patients with both alcohol and opioid use disorders, indicating a need for further studies to develop effective treatment approaches for this dual diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alcohol use in opioid agonist treatment. Nolan, S., Klimas, J., Wood, E.[2018]

Citations

1. withpower.com withpower.com/trial/phase-alcohol-drinking-2023-95e73

Brief Intervention for Opioid Use Disorder with Alcohol ... The COAPS medical study, being run by University of Utah, needs participants to evaluate whether Alcohol-targeted Brief Intervention-Medication Therapy ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10926351/

Co-use of Opioid Medications and Alcohol Prevention Study ... Our research has shown 20–30% of community pharmacy patients receiving opioid pain medications are engaged in co-use.

3. researchgate.net researchgate.net/publication/395523317_Impact_of_Community_Pharmacists_on_Reducing_Opioid_and_Alcohol_Co-Use_A_Pilot_Randomized_Control_Trial_of_a_Medication_Therapy_Management_Intervention

A Pilot Randomized Control Trial of a Medication Therapy ... Prior research has shown that 20%–30% of patients receiving opioid medications in community pharmacies engage in high‐risk drinking. We adapted a medication ...

4. accpjournals.onlinelibrary.wiley.com accpjournals.onlinelibrary.wiley.com/doi/abs/10.1002/jac5.70113

Impact of Community Pharmacists on Reducing Opioid and ... Participants were randomized to standard medication counseling (SMC) or alcohol-targeted brief intervention-medication therapy management (ABI- ...

5. uptodate.com uptodate.com/contents/alcohol-use-disorder-pharmacologic-management

Alcohol use disorder: Pharmacologic management - UpToDate Medication development has focused on several neurotransmitter systems that mediate reinforcement, including opioid, glutamate, gamma-aminobutyric acid, and ...

6. reporter.nih.gov reporter.nih.gov/search/MRc_7ok88EOeMvtH5sUMOQ/project-details/10836408

RePORT RePORTER - National Institutes of Health (NIH) | We propose to adapt, manualize, and test the acceptability, feasibility, and preliminary efficacy of an Alcohol-targeted Brief Intervention-Medication Therapy ...

7. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/72/NCT05599672/Prot_SAP_000.pdf

Co-Use of Opioid Medications and Alcohol Prevention Study NCT SPECIFIC AIMS. Co-use of alcohol and opioid medications can result in serious individual harm. Given alcohol and opioids act on μ-opioid receptors,1 ...