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

Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Subjects will be randomized to receive the brief opioid-informed treatment or treatment as usual.
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)
Masking Description
PI Carpenter and study therapists will be blinded to assessment outcomes, and assessment RAs will be blinded to participant condition.

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

The University of Notre Dame
Notre Dame, Indiana 46556
Contact:
Beth A Arnold, M.S.
574-213-2096
bhanawal@nd.edu

More Details

Status
Recruiting
Sponsor
University of Notre Dame

Study Contact

Ryan Carpenter, PhD
+1 574-631-5429
ryancarpenter@nd.edu

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.