Paschen-Wolff Margaret M, Campbell Aimee N C, Vásquez Ángel, Kessler Jill, Jansen Kelley, Arnatt Catherine P, Rosa Carmen, Hebden Hanna M, Radin Sandra, Stately Antony, Shaw Jennifer, Kennedy Favian, Matthews Abigail G, Venner Kamilla L
Columbia University Irving Medical Center, Department of Psychiatry and New York State Psychiatric Institute, Division on Substance Use Disorders, 1051 Riverside Drive, Unit 120, New York, NY 10032, USA.
Columbia University Irving Medical Center, Department of Psychiatry and New York State Psychiatric Institute, Division on Substance Use Disorders, 1051 Riverside Drive, Unit 120, New York, NY 10032, USA.
Contemp Clin Trials. 2025 Aug;155:107992. doi: 10.1016/j.cct.2025.107992. Epub 2025 Jun 20.
Incorporating American Indian and Alaska Native (AI/AN) traditional practices and knowledge into healthcare can support AI/AN health. Drug overdose deaths disproportionately impact AI/AN communities due to colonization, genocide, historical trauma, discriminatory policies, and under-resourced healthcare. Medications for opioid use disorder (MOUD; e.g., buprenorphine, methadone, naltrexone) are considered the most effective treatment for reducing mortality. Integrating AI/AN cultural practices with MOUD may increase acceptability and uptake of MOUD within AI/AN communities.
National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN) Protocol #0096 (Tribal MOUD) is a two-phase community-based participatory research (CBPR) trial to develop and evaluate an implementation intervention to culturally center MOUD delivery in AI/AN communities (N = 4 sites). A Collaborative Board (CB) guided intervention development (Phase I completed). A stepped wedge design (two sites/step) allows intervention implementation at all sites and improvements across sites (Phase II ongoing). The primary implementation outcome is the number of consumers with OUD who initiate MOUD in the six months pre-intervention vs. implementation periods; secondary outcomes are MOUD screening and retention (de-identified electronic medical record data). Additional data include organizational predictors (staff surveys) and moderators (consumer assessments) of implementation outcomes; and MOUD intervention acceptability (staff/consumer qualitative interviews).
This is the first study to develop and evaluate an implementation intervention to culturally center MOUD delivery in AI/AN communities. Implementation science and CBPR are complimentary for co-developing strategies with AI/AN communities to integrate Indigenous and Western best practices, which may ultimately reduce opioid-related mortality among AI/AN peoples and enhance Indigenous community wellness. Clinical Trials NCT Registration Number:NCT04958798.
将美国印第安人和阿拉斯加原住民（AI/AN）的传统习俗和知识融入医疗保健可促进AI/AN群体的健康。由于殖民统治、种族灭绝、历史创伤、歧视性政策以及医疗资源不足，药物过量死亡对AI/AN群体的影响尤为严重。阿片类物质使用障碍药物（MOUD；例如丁丙诺啡、美沙酮、纳曲酮）被认为是降低死亡率的最有效治疗方法。将AI/AN文化习俗与MOUD相结合可能会提高AI/AN群体对MOUD的接受度和使用率。
美国国立药物滥用研究所（NIDA）临床试验网络（CTN）协议#0096（部落MOUD）是一项两阶段的基于社区的参与性研究（CBPR）试验，旨在开发和评估一项实施干预措施，以使AI/AN社区的MOUD服务以文化为中心（N = 4个地点）。一个协作委员会（CB）指导干预措施的开发（第一阶段已完成）。阶梯楔形设计（两个地点/步骤）允许在所有地点实施干预措施并在各地点进行改进（第二阶段正在进行）。主要实施结果是在干预前六个月与实施期间开始接受MOUD治疗的患有阿片类物质使用障碍（OUD）的消费者数量；次要结果是MOUD筛查和留存率（去识别化的电子病历数据）。其他数据包括实施结果的组织预测因素（员工调查）和调节因素（消费者评估）；以及MOUD干预措施的可接受性（员工/消费者定性访谈）。
这是第一项开发和评估一项实施干预措施以使AI/AN社区的MOUD服务以文化为中心的研究。实施科学和CBPR相辅相成，可与AI/AN社区共同制定策略，整合本土和西方的最佳实践，这最终可能降低AI/AN群体中与阿片类药物相关的死亡率，并促进本土社区的健康。临床试验NCT注册号：NCT04958798。
