Alcohol Use, Alcohol Use Disorder, Opioid Use, Opioid Use Disorder
Conditions
Keywords
Alcohol Use Disorder, Alcohol Use Disorder (AUD), Cognitive Behavioral Therapy, Opioid Use Disorder, Opioid Use Disorder (OUD), Motivational Enhancement Therapy, Cognitive Behavior Therapy (CBT)
Brief summary
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.
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.
Interventions
BEHAVIORALBrief 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.
Sponsors
University of Notre Dame
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
PI Carpenter and study therapists will be blinded to assessment outcomes, and assessment RAs will be blinded to participant condition.
Intervention model description
Subjects will be randomized to receive the brief opioid-informed treatment or treatment as usual.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of the treatment | 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%. |
| Feasibility of the treatment | 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. |
Countries
United States
Contacts
CONTACTRyan Carpenter, PhD
CONTACTBeth A Arnold, M.S.
Outcome results
None listed