Towards Testing the Effectiveness of Recovery Community Centers (RCCs)

Официальное название

R34 Study 2 - Pilot RCT Testing the Effectiveness of RCCs

Обзор

The goal of this pilot randomized clinical trial is to prepare for a larger randomized clinical trial (RCT) and collect some early data to learn if the intervention can help people who use medications for opioid use disorder (MOUD). The main questions it aims to answer are: 1. Is it feasible to recruit and randomize people to both treatment groups? 2. Does linking people to recovery community centers lead to better recovery outcomes? Researchers will compare linking people to recovery community centers (RCC) to enhanced treatment as usual to see if recovery outcomes are different. In one group, participants will learn about their local RCC and will be asked to visit their local RCC on at least two days and write about their experiences. In the other group, participants will learn about different recovery activities, pick any two, and do the activities of their choice on at least two days. They will also be asked to write about their experiences. People in both groups will answer online survey questions about their recovery outcomes and well-being in five surveys over one year.

Подробное описание

The goal of this study is to prepare for a large-scale RCT. The current study is a pilot randomized clinical trial (RCT) comparing RCC linkage vs. enhanced treatment as usual (ETAU). Persons engaged in MOUD clinical care (n=128) at MOUD-providing clinics near RCCs serving Black communities will be recruited nationwide. The aims of this study are:

Aim 1: Determine the number of study participants enrolled per month. This information will be used for planning a subsequent R01, in line with the goals of the R34 mechanism used to fund this study.

Aim 2: Determine the feasibility of the chosen randomization procedures and groups in terms of (a) study enrollment, (b) completion of recovery activity assignments, and (c) completion of follow-up assessments.

Exploratory Aim 3: Estimate the size of treatment group differences on recovery outcomes over time, including on (a) the Substance Use Recovery Evaluator (SURE); (b) the Brief Measure of Recovery (BMR-4; derived from the Substance Abuse and Mental Health Services Administration's (SAMHSA) definition of recovery); (c) Experience Of Support (derived from SAMHSA goals of peer recovery support services); (d) Brief Assessment of Recovery Capital (BARC-10); and (e) self-report of participation in recovery support services.

Of note, this is a community-engaged research project, involving three community partners (i.e., the Detroit Recovery Project (DRP), Northern Ohio Recovery Association (NORA), and Let's Talk Safety (PILLARS)).

Вмешательства

• Поведенческое Recovery Community Center Participation
  Recovery community centers are brick and mortar buildings that house recovery-oriented organizations, located in the heart of their communities. They act as recovery hubs, offering a variety of recovery support services in house as well as connecting participants to resources in their area. They are peer-led organizations that are open to anyone in early or long-term recovery from substance use and that recognize that there are multiple pathways to recovery. Study participants will be provided w
• Поведенческое Enhance Treatment as Usual
  In this study, the enhanced treatment as usual intervention will encompass providing participants with information about diverse recovery activities (e.g., mutual help group meetings, exercise, job search, recovery coach meetings, etc.) and then to assign participants to complete a recovery activity of their choosing one two different days within one month after enrollment. Participants can do the same activity twice, or different activities on each of the two days assigned.

Первичные конечные точки

• Recruitment Rate [Срок оценки: Baseline]

Вторичные конечные точки (4)

• Study Withdrawals [Срок оценки: 1 month]
• Completion of Recovery Activities [Срок оценки: 1 month]
• Completion of Follow-up Surveys [Срок оценки: Baseline, 1, 3, 6, and 12 month]
• Completion of Timeline Follow-Back (TLFB) Interviews [Срок оценки: Baseline, 1, 3, 6, and 12 months]

Критерии участия

Критерии включения

• 18+ years of age
• Uses MOUD (at enrollment; participants may stop using MOUD subsequently) to treat OUD
• Receives MOUD from a clinic/pharmacy located within 15 miles of an RCC vetted by our study team, which serves a Black community (i.e., defined as being located in a ZIP code where ≥27% of the residents are Black, as per US Census)
• Is willing and able to engage in study procedures (i.e., online surveys, timeline follow back interview)
• Is willing to be randomized

Критерии исключения

\- Has visited a vetted RCC during the past 3 months

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

Открытое

Основная цель

Организация здравоохранения

Центры проведения

США · 1 центр

• Massachusetts General Hospital — Boston

Идентификаторы

NCT: NCT07010978 · 2025P001189 · 1R34DA057604-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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