An interventional study of Brief opioid-informed alcohol treatment in Alcohol Use Disorder, Opioid Use Disorder and Alcohol Use, sponsored by University of Notre Dame. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-09.
Sponsored by University of Notre Dame · Not applicable, Interventional, and 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.
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.
1,674 studies on the registry are indexed under Alcoholism; 331 are open to participants now.
This study's planned enrollment of 60 is below the median of 88 across 1,428 interventional studies indexed under Alcoholism.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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)
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)
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.
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.
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.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Per sponsor requirements, all data will be uploaded to the NIAAA Data Repository.
Time frame: One year after the completion of the project.
Access criteria: As required by the Sponsor, the data from this clinical trial will be uploaded to the National Institute on Alcohol Abuse and Alcoholism (NIAAA) data repository. Like all NIAAA grants, the NIAAA will govern the access criteria.
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