Testing the Effects of Contingency Management and Behavioral Economics on Buprenorphine-Naloxone Treatment Adherence Using a Sequential Multiple Assignment Randomized Trial (SMART) Design

使用序贯多重分配随机试验 (SMART) 设计测试应急管理和行为经济学对丁丙诺啡-纳洛酮治疗依从性的影响

• 批准号: 10474683
• 负责人: Karen J Derefinko
• 金额: $ 247.76万
• 依托单位: UNIVERSITY OF TENNESSEE HEALTH SCI CTR
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-28 至 2024-09-19
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10474683
• 关键词: Testing; Effects; Contingency; Management; Behavioral

This application to the RFA-AT-19-006 HEAL Initiative: Behavioral Research to Improve MAT: Behavioral and Social Interventions to Improve Adherence to Medication Assisted Treatment for Opioid Use Disorders (R61/R33 Clinical Trial Optional) will develop and execute a Sequential Multiple Assignment Randomized Trial (SMART) Design to test two forms of behavioral economics intervention to promote Medication Assisted Treatment (MAT) for Opioid Use Disorder. The R61 phase will collect qualitative and quantitative data from existing buprenorphine-naloxone patients to explore modifiable factors that may impact MAT adherence. This information will be used to adapt an in person, brief motivational interviewing and substance free activities intervention (BMI+SFAS) previously developed to reduce binge/problematic drinking and marijuana use. This BMI+SFAS will be compared with contingency management, one of the most effective forms of psychosocial treatment for substance use. After the development phase, both forms of intervention will be tested for satisfaction and acceptability with participants who are initiating buprenorphine-naloxone treatment. Feasibility of methods will also be assessed during this pilot to identify any issues with execution. The R33 phase of this application will execute a Sequential Multiple Assignment Randomized Trial (SMART) to test these two different forms of intervention to promote MAT adherence during the four weeks of treatment initiation, and throughout the following 6 months of MAT. Adherence to buprenorphine-naloxone will be defined as attendance at physician visits, a positive urine screen for buprenorphine-naloxone, and prescription drug monitoring. After the first randomization, we predict that a higher percentage of those in the contingency management condition will be adherent than those in BMI+SFAS. Those who are adherent throughout the first 4 weeks will continue in their arm of intervention for the next 6 months, but those non-adherent with be re- randomized to either switch to the other form of intervention or add the other form of intervention. Adherence will then be assessed again after 6 months of intervention. This innovative design that tests the sequential use of two psychosocial interventions to increase adherence to MAT initiation is likely to have a significant impact on engagement of Opioid Use Disorder patients in treatment. The use of a SMART design will test multiple levels of intervention for individuals who are resistant to MAT adherence, therefore addressing an underserved population with Opioid Use Disorder.

本申请的RFA-AT-19-006 HEAL倡议：行为研究，以改善MAT：行为和 提高阿片类药物使用障碍药物辅助治疗依从性的社会干预 (R61/R33临床试验（可选）将开发并执行一项序贯多重分配随机试验 （SMART）设计测试两种形式的行为经济学干预，以促进药物辅助治疗 阿片类药物使用障碍的治疗（MAT）。R61阶段将从以下方面收集定性和定量数据： 现有的丁丙诺啡-纳洛酮患者探索可能影响MAT依从性的可改变因素。这 信息将用于调整一个人，简短的动机访谈和物质自由活动 干预（BMI+SFAS）以前开发的，以减少酗酒/问题饮酒和大麻的使用。这 BMI+SFAS将与应急管理进行比较，应急管理是最有效的心理社会干预形式之一。 物质使用的治疗。在开发阶段之后，将对这两种形式的干预措施进行测试， 开始丁丙诺啡-纳洛酮治疗的受试者的满意度和可接受性。可行性 在试点期间还将评估各种方法，以查明执行方面的任何问题。R33阶段 应用程序将执行顺序多分配随机试验（SMART），以测试这两个 在治疗开始的四周内，采用不同形式的干预措施促进MAT依从性，以及 在接下来的6个月里，对丁丙诺啡-纳洛酮的依从性定义为 参加医生访视，丁丙诺啡-纳洛酮和处方药尿液筛查阳性 监测.在第一次随机化后，我们预测， 管理状况将比BMI+SFAS更好。那些坚持在第一次 在接下来的6个月里，他们将继续进行为期4周的干预，但那些不遵守的人将重新接受治疗。 随机分配至另一种形式的干预或添加另一种形式的干预。粘附 然后在干预6个月后再次进行评估。这种创新的设计，测试顺序使用 两个心理社会干预，以增加坚持MAT启动可能会产生重大影响 阿片类药物使用障碍患者的治疗。SMART设计的使用将测试多个 对MAT依从性有抵抗力的个人的干预水平，因此解决了服务不足的问题。 阿片类药物使用障碍的人群。