Department of Health Law, Policy & Management, Boston University School of Public Health, 715 Albany Street, Boston, MA 02118, USA; Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, 222 Richmond Street, Providence, RI 02903, USA.
Department of Medicine, Section of General Internal Medicine, Boston Medical Center, Clinical Addiction Research and Education (CARE) Unit, 801 Massachusetts Avenue, 2nd Floor, Boston, MA 02118, USA.
Contemp Clin Trials. 2024 Aug;143:107608. doi: 10.1016/j.cct.2024.107608. Epub 2024 Jun 13.
Persons receiving prescription buprenorphine for opioid use disorder experience high rates of comorbid conditions such as chronic pain and depression, which present barriers to buprenorphine care retention. This paper describes the protocol of the TOPPS (Treating Opioid Patients' Pain and Sadness) study, which compares a values-based, behavioral activation intervention with a health education contact-control condition, with the aim of decreasing chronic pain and depression, and increasing buprenorphine care retention for persons with opioid use disorder.
This randomized controlled trial (RCT) enrolls and randomizes up to 250 participants currently being treated with buprenorphine to receive three months of either TOPPS, a six-session phone-based behavioral intervention, or a health education (HE) control condition. We compare the TOPPS intervention to HE on the following outcomes: 1) pain interference and pain severity over the 3-month treatment phrase; 2) depressive symptoms over the 3-month treatment phase; and 3) sustained improvements in pain interference, depressive symptoms, and buprenorphine treatment retention over the 12-month study period. We also examine mechanisms by which the intervention may reduce pain interference.
This RCT explores a novel intervention to address chronic pain and depression for individuals receiving buprenorphine in office-based settings. TOPPS may lead to improved pain, depression, and substance use outcomes, and can utilize providers available within buprenorphine programs, broadening the disseminability of this intervention and heightening its public health impact.
#NCT03698669.
接受处方丁丙诺啡治疗阿片类药物使用障碍的患者常伴有慢性疼痛和抑郁等共病，这给丁丙诺啡治疗的保留带来了障碍。本文介绍了 TOPPS（治疗阿片类药物患者的疼痛和悲伤）研究的方案，该研究比较了基于价值观的行为激活干预与健康教育对照条件，目的是降低慢性疼痛和抑郁，并增加阿片类药物使用障碍患者的丁丙诺啡治疗保留率。
这项随机对照试验（RCT）招募并随机分配了最多 250 名目前正在接受丁丙诺啡治疗的参与者，他们将接受为期三个月的 TOPPS、六次电话行为干预或健康教育（HE）对照条件。我们将 TOPPS 干预与 HE 进行比较，比较以下结果：1）治疗期 3 个月内的疼痛干扰和疼痛严重程度；2）治疗期 3 个月内的抑郁症状；3）在 12 个月的研究期间，疼痛干扰、抑郁症状和丁丙诺啡治疗保留的持续改善。我们还研究了干预可能减轻疼痛干扰的机制。
这项 RCT 探索了一种新的干预措施，以解决接受门诊丁丙诺啡治疗的个体的慢性疼痛和抑郁问题。TOPPS 可能会改善疼痛、抑郁和物质使用的结果，并能利用丁丙诺啡治疗计划中现有的提供者，扩大这种干预措施的可传播性，并提高其公共卫生影响。
#NCT03698669。
