Better Experiences in Substance Treatment: A Brief Alcohol-focused Intervention Tailored for Patients in Opioid Agonist Treatment

NCT07342504 | Recruiting

• 2 other identifiers: ND24-05-8578K23AA029729
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study will help determine the feasibility and acceptability of a brief opioid-informed alcohol intervention in patients receiving prescribed buprenorphine for opioid use who are currently drinking alcohol. It will also provide initial information on whether the intervention improves outcomes related to alcohol use. The results of this proof-of-concept study will inform whether a future larger clinical trial is warranted.

Conditions

Alcohol Use; Opioid Use; Alcohol Use Disorder; Opioid Use Disorder

Keywords

Alcohol Use Disorder; Alcohol Use Disorder (AUD); Cognitive Behavioral Therapy; Opioid Use Disorder; Opioid Use Disorder (OUD); Motivational Enhancement Therapy; Cognitive Behavior Therapy (CBT)

Outcome Measures

Primary Outcomes (2)

• Acceptability of the treatment

  Acceptability will be assessed with the Satisfaction Questionnaire (CSQ-8), which ranges in scores from 8 to 32 (higher scores indicate higher satisfaction). Treatment satisfaction will be considered acceptable if the number and percentage of subjects who rate their treatment experience in the "satisfactory" or "highly satisfactory" range on the CSQ-8 is ≥ 80%.

  Assessed at Week 4 (end of trial)

• Feasibility of the treatment

  Retention feasibility will be determined by the number and percentage of enrolled participants who complete the four week treatment protocol.

  Assessed at Week 4 (end of trial)

Other Outcomes (3)

• Alcohol Use Quantity

  Change from baseline to end of treatment (week4), 1-, and 3-month follow up.

• Buprenorphine Treatment Status

  Change from baseline to end of treatment (week4), 1-, and 3-month follow up.

• Alcohol-related consequences

  Change from baseline to end of treatment (week4), 1-, and 3-month follow up.

Study Arms (2)

Treatment As Usual

NO INTERVENTION

No intervention is administered. All participants in this study receive prescribed buprenorphine for opioid use disorder and may, related to this, receive behavioral intervention focused on medication adherence and preventing opioid relapse. Treatment As Usual refers to receiving this and no additional intervention.

Experimental: Brief opioid-informed alcohol treatment

EXPERIMENTAL

The brief opioid-informed alcohol treatment is based upon principles of Motivation Enhancement Therapy (MET) and Cognitive Behavioral Therapy (CBT) tailored to the needs of patients in opioid treatment. Delivered once per week for 4 weeks.

Behavioral: Brief opioid-informed alcohol treatment

Interventions

Brief opioid-informed alcohol treatment BEHAVIORAL

The brief opioid-informed alcohol treatment is based upon principles of Motivation Enhancement Therapy (MET) and Cognitive Behavioral Therapy (CBT) tailored to the needs of patients in opioid treatment. Participants will attend weekly in-person sessions for four weeks.

Experimental: Brief opioid-informed alcohol treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must be taking prescribed buprenorphine for at least 2 weeks
• Participants must be 18 years or older.
• Meet DSM-5 criteria for alcohol use disorder (AUD)
• Participants must report alcohol use ≥ 1 day/week on average in the past 28 days
• Participants must be able to read simple English

You may not qualify if:

• Currently receiving formal alcohol use treatment.

Sponsors & Collaborators

• University of Notre Dame: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

The University of Notre Dame

Notre Dame, Indiana, 46556, United States

RECRUITING

MeSH Terms

Conditions

Alcoholism; Opioid-Related Disorders; Alcohol Drinking

Interventions

Ethanol; Therapeutics

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Narcotic-Related Disorders; Drinking Behavior; Behavior

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Central Study Contacts

Ryan Carpenter, PhD

CONTACT

+1 574-631-5429; ryancarpenter@nd.edu

Beth A Arnold, M.S.

CONTACT

574-213-2096; bhanawal@nd.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: PI Carpenter and study therapists will be blinded to assessment outcomes, and assessment RAs will be blinded to participant condition.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Subjects will be randomized to receive the brief opioid-informed treatment or treatment as usual.

Study Record Dates

• First Submitted: January 13, 2026
• First Posted: January 15, 2026
• Study Start: January 21, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Time Frame: One year after the completion of the project.
• Access Criteria: As required by the Sponsor, the data from this clinical trial will be uploaded to the National Institute on Alcohol Abuse and Alcoholism (NIAAA) data repository. Like all NIAAA grants, the NIAAA will govern the access criteria.

Locations

US (1)