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NCT Number: NCT07342504

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Notre Dame

Notre Dame, Indiana, 46556, United States

Location status: Recruiting

Location contact

Beth A Arnold, M.S.

CONTACT

[email protected]

574-213-2096

Ryan Carpenter, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Acceptability of the treatment

    Time frame: Assessed at Week 4 (end of trial)

    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%.

  2. Feasibility of the treatment

    Time frame: Assessed at Week 4 (end of trial)

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

Other outcomes

  1. Alcohol Use Quantity

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

    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.

  2. Buprenorphine Treatment Status

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

    Whether the participant reports that they are currently receiving prescribed buprenorphine.

  3. Alcohol-related consequences

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

    Assessed using the Drinker Inventory of Consequences-Recent (DrINC-2R). Common, moderately common, and rare consequences will be examined separately.

Study contacts

Contact information is provided by the study sponsor or research team.

Beth A Arnold, M.S.

CONTACT

[email protected]

574-213-2096

Ryan Carpenter, PhD

CONTACT

[email protected]

+1 574-631-5429

Sponsors and collaborators

Lead sponsor

University of Notre Dame

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Acronym: Project BEST

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jan 15, 2026
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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