UCLA David Geffen School of Medicine, Department of Family Medicine, Center for Behavioral & Addiction Medicine, 16556 Park Lane Circle, Los Angeles, CA. 90049-1145, United States.
Indivior Inc., 10710 Midlothian Turnpike, Suite 430, Richmond, VA 23235, United States.
Contemp Clin Trials. 2019 Jan;76:93-103. doi: 10.1016/j.cct.2018.11.015. Epub 2018 Nov 30.
Few opioid use disorder (OUD) treatment studies measure meaningful life changes during long-term recovery, focusing instead on retention and abstinence. Here, we report on the design and participant characteristics of the RECOVER study, a study exploring life changes in persons with OUD for up to 24 months following participation in a Phase III trial evaluating buprenorphine extended-release monthly injection for subcutaneous use (known as RBP-6000 during development). This multisite, observational, cohort study tracks clinical, environmental, and socio-economic changes using self-administered assessments, urine drug screens (UDS), and public databases. Outcomes include demographics (e.g., patient characteristics, employment history, criminal history), lifetime and recent OUD drug use and treatment, and current health and resource use. Demographic and psychosocial characteristics are compared to a national, population-based study. RECOVER participants (N = 533) tend to be single, white, males aged 26 years or older. Mean age at first opioid use was 21.7 years; lifetime substance-related overdose was 24.2%. At first assessment, 334 (62.7%) participants reported past 7-day and 296 (55.5%) reported past 28-day opioid abstinence. Five hundred UDS were collected at the first assessment; buprenorphine (90.6%), marijuana (45.2%), and opiates (34.4%) were most commonly identified. Two hundred forty-nine (47.2%) participants reported full- or part-time employment. Participants were like a national sample with differences found for age, race/ethnicity, employment, education, and health-related quality of life. We hope that further research using this approach can provide data supporting the patient-centered development of OUD treatments and be adopted by substance use disorder studies to incorporate recovery-related, life-activity outcomes.
很少有阿片类药物使用障碍（OUD）治疗研究在长期康复期间衡量有意义的生活变化，而是侧重于保留和戒断。在这里，我们报告了 RECOVER 研究的设计和参与者特征，该研究旨在探索接受过为期三期试验评估的布比卡因缓释每月皮下注射（开发期间称为 RBP-6000）的 OUD 患者在参与试验后长达 24 个月的生活变化。这项多地点、观察性、队列研究使用自我评估、尿液药物筛查（UDS）和公共数据库来跟踪临床、环境和社会经济变化。结果包括人口统计学（例如，患者特征、就业历史、犯罪历史）、终生和近期 OUD 药物使用和治疗以及当前健康和资源使用情况。人口统计学和心理社会特征与全国性、基于人群的研究进行比较。RECOVER 参与者（N=533）倾向于单身、白人、年龄在 26 岁或以上的男性。首次使用阿片类药物的平均年龄为 21.7 岁；终生药物相关过量的发生率为 24.2%。在第一次评估时，334 名（62.7%）参与者报告了过去 7 天和 296 名（55.5%）参与者报告了过去 28 天的阿片类药物戒断。在第一次评估时收集了 500 份 UDS；最常识别的是丁丙诺啡（90.6%）、大麻（45.2%）和阿片类药物（34.4%）。249 名（47.2%）参与者报告全职或兼职就业。参与者与全国样本相似，但在年龄、种族/民族、就业、教育和健康相关生活质量方面存在差异。我们希望使用这种方法的进一步研究能够提供支持 OUD 治疗以患者为中心的开发的数据，并被药物使用障碍研究采用，纳入与康复相关的生活活动结果。
