The University of Notre Dame
Notre Dame, Indiana, 46556, United States
Location status: Recruiting
Location contact
Beth A Arnold, M.S.
CONTACT
Ryan Carpenter, PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07342504
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Notre Dame, Indiana, 46556, United States
Location status: Recruiting
Beth A Arnold, M.S.
CONTACT
Ryan Carpenter, PhD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for the RCT:
Exclusion criteria
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.
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%.
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.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Beth A Arnold, M.S.
CONTACT
Ryan Carpenter, PhD
CONTACT
University of Notre Dame
Other
Acronym: Project BEST
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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