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| ID | Type | Description | Link |
|---|---|---|---|
| K23AA029729 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment As Usual | No Intervention | 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: Brief opioid-informed alcohol treatment | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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%. | 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. | Assessed at Week 4 (end of trial) |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from baseline to end of treatment (week4), 1-, and 3-month follow up. |
| Buprenorphine Treatment Status |
Inclusion Criteria for the RCT:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ryan Carpenter, PhD | Contact | +1 574-631-5429 | ryancarpenter@nd.edu | |
| Beth A Arnold, M.S. | Contact | 574-213-2096 | bhanawal@nd.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Notre Dame | Recruiting | Notre Dame | Indiana | 46556 | United States |
Per sponsor requirements, all data will be uploaded to the NIAAA Data Repository.
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One year after the completion of the project.
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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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Apr 14, 2026 | Apr 21, 2026 |
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Subjects will be randomized to receive the brief opioid-informed treatment or treatment as usual.
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PI Carpenter and study therapists will be blinded to assessment outcomes, and assessment RAs will be blinded to participant condition.
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Whether the participant reports that they are currently receiving prescribed buprenorphine. |
| 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. | Change from baseline to end of treatment (week4), 1-, and 3-month follow up. |
| ICF_001.pdf |
| ID | Term |
|---|---|
| D000437 | Alcoholism |
| D009293 | Opioid-Related Disorders |
| D000428 | Alcohol Drinking |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D000079524 | Narcotic-Related Disorders |
| D004327 | Drinking Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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