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

ConditionsAlcohol Use DisorderOpioid Use DisorderAlcohol UseOpioid Use
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Notre Dame

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Currently receiving formal alcohol use treatment.

Currently experiencing psychosis

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Treatment As UsualNo intervention 0 interventions
Group B: Experimental: Brief opioid-informed alcohol treatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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%.

Time frame
Assessed at Week 4 (end of trial)
2

Feasibility of the treatment

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

Time frame
Assessed at Week 4 (end of trial)

Secondary outcomes

Other outcomes

1

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.

Time frame
Change from baseline to end of treatment (week4), 1-, and 3-month follow up.
2

Buprenorphine Treatment Status

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

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

Alcohol-related consequences

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

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Notre Dame

Lead sponsor

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Source ClinicalTrials.gov
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