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

44 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment Alcohol-targeted Brief Intervention-Medication Therapy Management for opioid use disorder with alcohol consumption?

Research shows that brief interventions can help reduce alcohol use in people with opioid dependence, and naltrexone (Revia, Vivitrol) is effective for treating alcohol dependence, although patient adherence can vary. ^{1 2 3 4 5}

Is the treatment for opioid use disorder with alcohol consumption safe for humans?

Research on naltrexone (Revia, Vivitrol) and buprenorphine (Suboxone) shows they have been used safely in humans for treating alcohol and opioid dependence. However, combining treatments for both conditions requires careful management, as alcohol misuse can complicate treatment for opioid addiction. ^{3 4 6 7 8}

How is the Alcohol-targeted Brief Intervention-Medication Therapy Management treatment different from other treatments for opioid use disorder with alcohol consumption?

This treatment is unique because it combines a brief intervention specifically targeting alcohol use with medication therapy management, which may include drugs like Vivitrol or ReVia that are not typically used together in standard opioid use disorder treatments. This approach addresses both alcohol and opioid use disorders simultaneously, which is less common in existing treatments. ^{1 3 5 7 9}

What is the purpose of this trial?

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.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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 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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Alcohol-related brief intervention in patients treated for opiate or cocaine dependence: a randomized controlled study. [2021]

2. Spain pubmed.ncbi.nlm.nih.gov

[Alcohol consumption in opioid-dependence patients in treatment with naltrexone]. [2013]

3. United States pubmed.ncbi.nlm.nih.gov

Alcohol Screening among Opioid Agonist Patients in a Primary Care Clinic and an Opioid Treatment Program. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Adherence monitoring in naltrexone pharmacotherapy trials: a systematic review. [2022]

5. England 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. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Does family history of alcoholism moderate naltrexone's effects on alcohol use? [2019]

7. England pubmed.ncbi.nlm.nih.gov

Alcohol use in opioid agonist treatment. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Buprenorphine + naloxone plus naltrexone for the treatment of cocaine dependence: the Cocaine Use Reduction with Buprenorphine (CURB) study. [2018]

9. Ireland pubmed.ncbi.nlm.nih.gov

An examination between treatment type and treatment retention in persons with opioid and co-occurring alcohol use disorders. [2022]