Recruiting

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

Sponsor:

University of Notre Dame

Code:

NCT07342504

Conditions

Alcohol Use Disorder

Opioid Use Disorder

Alcohol Use

Opioid Use

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Brief opioid-informed alcohol treatment

Study Details

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 Disorder

Opioid Use Disorder

Alcohol Use

Opioid Use

Study ID

NCT07342504

Start date

Mar 24, 2026

Status verified date

Jun, 2026

Completion date

Mar 1, 2027

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Brief opioid-informed alcohol treatment

Primary outcome measure

Acceptability of the treatment [ Time Frame: Assessed at Week 4 (end of trial) ]
Feasibility of the treatment [ Time Frame: Assessed at Week 4 (end of trial) ]

Central Contacts and Locations

Central contacts

Ryan Carpenter, PhD

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

Beth A Arnold, M.S.

574-213-2096 bhanawal@nd.edu

Locations

The University of Notre Dame

Recruiting

Notre Dame, Indiana, United States, 46556

Contacts

Beth A Arnold, M.S.

574-213-2096 bhanawal@nd.edu

Principal Investigator:

Ryan Carpenter, PhD

More Information

Sponsor

University of Notre Dame

Last update posted

Jun 9, 2026

Last verified

Jun, 2026

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)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-29. This information was provided to ClinicalTrials.gov by University of Notre Dame on 2026-06-09. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.