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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Alcohol Use; Opioid Use Disorder; Alcohol Use Disorder; Opioid Use
• Intervention / Treatment: Behavioral: Brief opioid-informed alcohol treatment

Detailed Description

Alcohol use is an under-recognized contributor to the ongoing opioid overdose epidemic, increasing the risk of overdose when used together with opioids. Further, alcohol use and related problems are prevalent among patients in opioid agonist treatment (OAT) and increase the risk of opioid relapse and early departure from treatment. Office-based buprenorphine treatment, a fast-growing form of OAT, is effective at treating opioid use disorder and decreasing risk of opioid overdose, but relapse rates are high in the first year of treatment. There is a significant need to improve treatment retention. Reducing alcohol use and use-related problems in patients receiving buprenorphine may have a significant indirect effect on improving buprenorphine outcomes. However, minimal existing work has examined alcohol interventions in this population. Of the few studies that have, all of them tested standard alcohol interventions that were not tailored to the unique circumstances of opioid treatment or the needs of individuals in OAT. The purpose of this study is to examine the feasibility and acceptability of a brief opioid-informed alcohol intervention and whether the intervention can improve alcohol outcomes. The intervention is based upon principles of motivational enhancement therapy and cognitive behavioral therapy and tailored to the needs of patients receiving OAT.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ryan Carpenter, PhD; Phone Number: +1 574-631-5429; Email: ryancarpenter@nd.edu
• Study Contact Backup: Name: Beth A Arnold, M.S.; Phone Number: 574-213-2096; Email: bhanawal@nd.edu

Study Locations

• United States
  • Indiana
    • Notre Dame, Indiana, United States, 46556
      • Recruiting
      • The University of Notre Dame
      • Contact: Beth A Arnold, M.S.; Phone Number: 574-213-2096; Email: bhanawal@nd.edu
      • Principal Investigator: Ryan Carpenter, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria for the RCT:

• 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

Exclusion Criteria:

• Currently receiving formal alcohol use treatment.
• Currently experiencing psychosis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Treatment As Usual; 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: Experimental: Brief opioid-informed alcohol treatment; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alcohol Use Quantity	Assessed using Timeline Followback. Typical weekly drinking quantity estimates will be summed to create a "drinks per week" total score, which will be used as our outcome variable.	Change from baseline to end of treatment (week4), 1-, and 3-month follow up.
Buprenorphine Treatment Status	Whether the participant reports that they are currently receiving prescribed buprenorphine.	Change from baseline to end of treatment (week4), 1-, and 3-month follow up.
Alcohol-related consequences	Assessed using the Drinker Inventory of Consequences-Recent (DrINC-2R). Common, moderately common, and rare consequences will be examined separately.	Change from baseline to end of treatment (week4), 1-, and 3-month follow up.

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: January 13, 2026
• First Submitted That Met QC Criteria: January 13, 2026
• First Posted (Actual): January 15, 2026

Study Record Updates

• Last Update Posted (Actual): June 9, 2026
• Last Update Submitted That Met QC Criteria: June 5, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Opioid Use Disorder; Cognitive Behavioral Therapy; Alcohol Use Disorder; Opioid Use Disorder (OUD); Motivational Enhancement Therapy; Cognitive Behavior Therapy (CBT); Alcohol Use Disorder (AUD)
• Additional Relevant MeSH Terms: Narcotic-Related Disorders; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Drinking Behavior; Alcohol-Related Disorders; Behavior; Opioid-Related Disorders; Alcoholism; Alcohol Drinking; Organic Chemicals; Alcohols; Ethanol; Therapeutics
• Other Study ID Numbers: ND24-05-8578; K23AA029729 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Per sponsor requirements, all data will be uploaded to the NIAAA Data Repository.
• IPD Sharing Time Frame: One year after the completion of the project.
• IPD Sharing 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No