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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.

Первичные конечные точки

• Acceptability of the treatment [Срок оценки: Assessed at Week 4 (end of trial)]
• Feasibility of the treatment [Срок оценки: Assessed at Week 4 (end of trial)]

Критерии участия

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

Критерии исключения

• Currently receiving formal alcohol use treatment.
• Currently experiencing psychosis

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• The University of Notre Dame — Notre Dame

Идентификаторы

NCT: NCT07342504 · ND24-05-8578 · K23AA029729

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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