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

NCT ID: NCT07342504

Last Updated: 2026-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-21

Study Completion Date

2027-03-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Alcohol Use Disorder Opioid Use Disorder Alcohol Use Opioid Use

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Subjects will be randomized to receive the brief opioid-informed treatment or treatment as usual.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
PI Carpenter and study therapists will be blinded to assessment outcomes, and assessment RAs will be blinded to participant condition.

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Brief opioid-informed alcohol treatment

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role collaborator

University of Notre Dame

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The University of Notre Dame

Notre Dame, Indiana, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Ryan Carpenter, PhD

Role: CONTACT

+1 574-631-5429

Beth A Arnold, M.S.

Role: CONTACT

574-213-2096

Facility Contacts

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Beth A Arnold, M.S.

Role: primary

574-213-2096

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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K23AA029729

Identifier Type: NIH

Identifier Source: secondary_id

View Link

ND24-05-8578

Identifier Type: -

Identifier Source: org_study_id

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