Набор скоро начнётся NCT05245513

Enhancing Recovery Capital Amid Opioid Use Disorder Pharmacotherapy: A Pilot Randomized Trial

Без фазы С лечением Opioid Use Disorder

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Recovery Community Center Linkage (RCCL), Control Condition (CC).
Кому может быть актуально: Состояния в реестре: Opioid Use Disorder. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Developing and Testing an Intervention to Enhance Recovery Capital Amid Opioid Use Disorder Pharmacotherapy: A Pilot Randomized Trial of Linkage to Recovery Support Services

Обзор

The aims of the current study are to: Aim 1. Develop and refine a novel intervention protocol for individuals receiving medication treatment for opioid use disorder that assertively links them to recovery community centers; Aim 2. Determine the feasibility, acceptability, and preliminary efficacy of assertive linkage to recovery community centers relative to a matched control condition, via a pilot randomized controlled trial; Aim 3. Explain quantitative findings by gaining an in-depth understanding of the intervention's feasibility, acceptability, and preliminary efficacy via qualitative interviews.

Подробное описание

This 5-year project seek to advance our understanding of the clinical and public health utility of recovery community centers and help bridge the gap between clinical treatment and community-based recovery support services. As a first step in this work, the investigators will develop and test a new intervention for peer-facilitated assertive linkage of patients receiving opioid use disorder pharmacotherapy to recovery community centers (RCCL), relative to a matched control condition (CC). This study aims to: Aim 1. Develop, manualize, and refine RCCL and CC protocols via stakeholder feedback. RCCL and CC protocols will be developed and manualized by adapting published community-based mutual-help linkage protocols. Upon preliminary manual development, feedback cycles will be conducted with relevant stakeholders (recovery coaches, recovery community center members, pharmacotherapy prescribers) to inform protocol revision, and promote its feasibility, acceptability, and adoptability. Aim 2. Determine the feasibility, acceptability, and preliminary efficacy of RCCL versus CC, via a pilot randomized controlled trial. More specifically, the feasibility of study procedures and RCCL/CC interventions, acceptability of interventions, and preliminary efficacy of RCCL relative to CC will be assessed. Aim 3. Explain quantitative findings by gaining an in-depth understanding of RCCL feasibility, acceptability, and efficacy via qualitative interviews in a subset of RCCL participants, peer facilitators, and linkage managers.

Вмешательства

Поведенческое Recovery Community Center Linkage (RCCL)
A certified recovery coach will meet with participants to educate them on recovery support services, including recovery community centers, and link them to a recovery community center, with the aid of a facilitated connection to a volunteer recovery community center member (e.g., calling a standby peer, scheduling a meet-up at the center). The coach will also provide the participant with a brochure of recovery support resources.
Поведенческое Control Condition (CC)
A certified recovery coach will meet with participants to educate them on recovery support services more broadly, including recovery community centers, and will provide them with a brochure of recovery support resources.

Первичные конечные точки

Overall recruitment feasibility [Срок оценки: Through study completion, ~3 years from recruitment initiation]
Overall intervention feasibility [Срок оценки: From the date of intervention manual finalization until the date of study completion, assessed up to 48 months]
Fidelity: Linkage manager adherence [Срок оценки: From date of first linkage manager meeting until the date of last linkage manager meeting, assessed up to 36 months]
Overall intervention acceptability [Срок оценки: Month 1]
Overall intervention satisfaction [Срок оценки: Month 1]
Recovery community center attendance [Срок оценки: From the date of linkage manager meeting until the date of month-3 follow up, assessed up to 3 months]
Use of recovery support services [Срок оценки: From the date of linkage manager meeting until the date of month-3 follow up, assessed up to 3 months]

Вторичные конечные точки (5)

Participant retention [Срок оценки: From the date of first participant enrollment in the trial to the date of study completion, up to 42 months]
Feasibility of peer facilitator meet-ups [Срок оценки: Month 1; Month 3]
Intervention appropriateness [Срок оценки: Month 1]
Intervention helpfulness [Срок оценки: Month 1; Month 3]
Change in recovery capital from baseline to Month 3 [Срок оценки: Baseline; Month 1; Month 3]

Критерии участия

Критерии включения

age ≥ 18 years
past-year opioid use disorder diagnosis per the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition
currently undergoing outpatient buprenorphine treatment through a provider or program at Massachusetts General Hospital
current residence in Massachusetts