Integrating MOUD in Nonmedical Community Settings (Better Together)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 400
- 试验地点
- 8
- 主要终点
- Buprenorphine MOUD Treatment Retention
研究概览
简要总结
A multisite effectiveness-implementation study will be conducted in four sites to evaluate interventions to improve engagement and retention in MOUD with buprenorphine treatment persons with Opioid Use Disorder (OUD) in urban neighborhoods with high overdose rates. The investigators hypothesize that treatment with the Better Together Integrated Collaborative Community MOUD care model (BT-MOUD) will result in better retention in treatment than standard-of-care MOUD with buprenorphine provided in the hub buprenorphine clinic only (HC-MOUD Only) through 24 weeks following randomization. BT-MOUD provides MOUD with buprenorphine in nonmedical community-based settings via telemedicine from a hub buprenorphine clinic combined with Recovery Guiding, a manual guided coaching developed for this approach, provided onsite in the community organization.
详细描述
This multi-site hybrid Type 1 effectiveness-implementation study conducted in Washington, District of Columbia (DC), Chicago, Miami-Dade County and Baltimore will evaluate: 1) the effectiveness of providing MOUD with buprenorphine onsite (via telemedicine from a hub buprenorphine clinic) combined with Recovery Guiding in nonmedical community-based settings (the Better Together Integrated Collaborative Community MOUD care model - BT-MOUD) compared to standard-of-care MOUD with buprenorphine provided in the hub buprenorphine clinic only (HC-MOUD Only) and 2) BT-MOUD implementation barriers and facilitators. In the BT-MOUD intervention, community sites serve as "spokes" for telemedicine provision of MOUD by buprenorphine providers based in a "hub" buprenorphine clinic. A trained and supervised Recovery Guide with roots or connections with the community provides manual-guided Recovery Guiding on-site in the community site. Recovery Guiding includes psychoeducation (about OUD and effective buprenorphine MOUD) and behavioral counseling to promote engagement in MOUD with buprenorphine, retention in care, medication adherence, and behavioral change supportive of recovery. In HC-MOUD Only, participants will receive MOUD with buprenorphine and other available services in the hub buprenorphine clinic only. A Peer Outreach Specialist (POS) will assist with outreach and recruitment of all participants across conditions and with maintaining high rates of follow-up in research assessments. This study will test the hypothesis that BT-MOUD is more effective than HC-MOUD Only in retaining persons with OUD in MOUD with buprenorphine through six months post-randomization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •In the 30 days prior to receiving the prescription for MOUD with buprenorphine from the hub clinic provider, has either taken prescribed MOUD as an outpatient for more than 10 consecutive days OR received injectable MOUD that covers more than 10 consecutive days [Note that receipt of MOUD in a hospital, residential treatment, or carceral setting would not trigger exclusion.]
- •Plans to move out of the area or anticipate not being able to remain in the study for 6 months
- •Is currently in jail, prison, or other overnight facility as required by a court of law or have pending legal action that could prevent participation in study activities
- •Has been previously enrolled in CTN-0144 or CTN-0088 or is currently enrolled in another clinical trial for treatment of OUD
结局指标
主要结局
Buprenorphine MOUD Treatment Retention
时间窗: 0-168 days
Duration of continuous participation in the hub clinic provided buprenorphine treatment
次要结局
- Urine Toxicology(Months 1,2 3,4,5,6)
- Health-related quality of life (HRQOL)(Months 1,2 3,4,5,6)
- Patient Health Questionnaire Depression Scale(Months 1,2,3,4,5,6)
- Self-reported adherence to MOUD with buprenorphine(0-168 days)
- Self-reported nonmedical opioid use(0-168 days)
- Self-reported nonmedical other drug use(0-168 days)
- Self-reported adherence to MOUD with buprenorphine(0-168 days)
- Self-reported nonmedical opioid use(0-168 days)
- Self-reported nonmedical other drug use(0-168 days)
- Urine Toxicology(Months 1,2 3,4,5,6)
- Health-related quality of life (HRQOL)(Months 1,2 3,4,5,6)
- Patient Health Questionnaire Depression Scale(Months 1,2,3,4,5,6)
- Pharmacy Dispensed Buprenorphine(Months 1, 2, 3, 4, 5, 6)
研究者
Richard Schottenfeld
Professor and Chair, Department of Psychiatry
Howard University