Shulman Matisyahu, Meyers-Ohki Sarah, Novo Patricia, Provost Scott, Ohrtman Kaitlyn, Van Veldhuisen Paul, Oden Neal, Otterstatter Michael, Bailey Genie L, Liu David, Rotrosen John, Weiss Roger D, Nunes Edward V
New York State Psychiatric Institute, 1051 Riverside Dr., New York, NY 10032, USA; Columbia University Irving Medical Center, 630 West 168(th) St., New York, NY 10032, USA.
New York University Grossman School of Medicine, 550 1(st) Ave., New York, NY 10016, USA.
Contemp Clin Trials. 2025 Mar;150:107816. doi: 10.1016/j.cct.2025.107816. Epub 2025 Jan 20.
The three medications approved to address OUD are effective in decreasing opioid use and morbidity and mortality; however, their utility is limited by high rates of dropout from treatment. The CTN-0100 trial will develop an evidence base for strategies to improve retention on buprenorphine and extended-release naltrexone.
The National Drug Abuse Treatment Clinical Trials Network (CTN) study CTN-0100, "Optimizing Retention, Duration and Discontinuation Strategies for Opioid Use Disorder Pharmacotherapy" (RDD), is a multicenter, randomized, non-blinded trial enrolling more than a thousand patients from 18 community-based substance use disorder treatment programs. Participants are adult volunteers seeking to initiate medication treatment for OUD (MOUD). Individuals choose between buprenorphine or extended-release injectable naltrexone. The trial randomizes participants choosing buprenorphine, in a 3 × 2 factorial design, to a medication condition (standard-dose sublingual buprenorphine, high-dose sublingual buprenorphine, or extended-release injectable buprenorphine) and to a behavioral condition (Medical Management or Medical Management plus a digital therapeutic (smartphone) app). Individuals choosing extended-release naltrexone are randomized only to a behavioral condition. Participants receive study medication for 74 weeks and are then followed for a further 24 weeks. The primary outcome is successful retention on MOUD at 26 weeks (six months), with 50- and 74-week retention among the secondary outcomes.
DISCUSSION/CONCLUSION: Dropout from treatment is a major barrier to the effectiveness of MOUD. The CTN-0100 study will determine whether strategies such as high dose sublingual or extended-release buprenorphine, or an app-based behavioral intervention improve retention on MOUD.
gov Identifier: NCT04464980.
三种获批用于治疗阿片类物质使用障碍（OUD）的药物在减少阿片类药物使用以及发病率和死亡率方面是有效的；然而，它们的效用受到治疗高脱落率的限制。CTN - 0100试验将为改善丁丙诺啡和长效纳曲酮治疗保留率的策略建立证据基础。
国家药物滥用治疗临床试验网络（CTN）的CTN - 0100研究，即“优化阿片类物质使用障碍药物治疗的保留率、持续时间和停药策略”（RDD），是一项多中心、随机、非盲试验，从18个社区物质使用障碍治疗项目中招募了一千多名患者。参与者是寻求开始阿片类物质使用障碍药物治疗（MOUD）的成年志愿者。个体在丁丙诺啡或长效注射用纳曲酮之间进行选择。该试验采用3×2析因设计，将选择丁丙诺啡的参与者随机分为药物治疗组（标准剂量舌下丁丙诺啡、高剂量舌下丁丙诺啡或长效注射用丁丙诺啡）和行为治疗组（药物管理或药物管理加数字治疗（智能手机）应用程序）。选择长效纳曲酮的个体仅随机分配到行为治疗组。参与者接受研究药物治疗74周，然后再随访24周。主要结局是26周（六个月）时成功保留在MOUD治疗中，次要结局包括50周和74周时的保留率。
讨论/结论：治疗脱落是MOUD有效性的主要障碍。CTN - 0100研究将确定高剂量舌下或长效丁丙诺啡等策略，或基于应用程序的行为干预是否能提高MOUD治疗的保留率。
美国国立医学图书馆临床试验注册库标识符：NCT04464980。
