Alexander Karen, Sharma Anjalee, Fletcher Jesse B, Smith Zoe, Huddleston Tori, Gryczynski Jan, Stitzer Maxine
Social Research Center, Friends Research Institute, Baltimore, MD, United States.
Front Psychiatry. 2025 Jul 2;16:1576277. doi: 10.3389/fpsyt.2025.1576277. eCollection 2025.
People in treatment for opioid use disorder (OUD) who also use cocaine are at heightened risk of early treatment discontinuation and poor outcomes. Digital therapeutics utilized within OUD treatment have the potential to impact public health by improving the evidence-based intervention delivery. Contingency management (CM) is an evidence-based intervention to reduce substance use, including cocaine. This article details a randomized controlled trial protocol that tests a digitally-delivered CM intervention for adult patients with co-occurring cocaine and opioid use entering methadone treatment.
This study will enroll 240 individuals within two weeks of beginning a new treatment episode at one of four participating opioid treatment programs (OTPs) in Baltimore, Maryland. Eligible adults must report past 30-day cocaine and opioid use at intake. Participants are randomized to receive either treatment as usual (TAU) or TAU plus the DynamiCare Contingency Management (DCM) app. The DCM app facilitates the provision of small monetary incentives for picking up methadone doses, completing cognitive behavioral therapy educational modules, and testing negative for cocaine or opioids on randomly-scheduled self-administered and validated oral fluid drug tests. The primary outcome is retention in methadone treatment. Participants are assessed at baseline, 3-, 6- and 12-months on measures including substance use and quality of life, and qualitative interviews are conducted with a subset of DCM-arm participants to assess acceptability and utility of the intervention. This trial was registered in the National Clinical Trials database on February 23, 2023, according to NIH policy (https://clinicaltrials.gov/study/NCT05766631).
This project will inform the ancillary content of methadone maintenance treatment for the many patients with substance use disorders that extend beyond opioids, specifically for those who use cocaine. The study's design will provide scientifically valid information about the effectiveness of digitally delivered CM, while app usage data and qualitative data from participants will be a rich resource for interpreting outcome results. CM is the only known evidence-based treatment for stimulant disorder, and digital delivery could solve many of the practical issues that have hampered widespread adoption of CM. Thus, the study could have both an important scientific and public health impact.
同时使用可卡因的阿片类物质使用障碍（OUD）治疗患者早期治疗中断和预后不良的风险更高。在OUD治疗中使用的数字疗法有可能通过改善循证干预措施的实施来影响公众健康。应急管理（CM）是一种用于减少包括可卡因在内的物质使用的循证干预措施。本文详细介绍了一项随机对照试验方案，该方案测试了一种通过数字方式提供的CM干预措施，用于同时使用可卡因和阿片类物质并开始美沙酮治疗的成年患者。
本研究将在马里兰州巴尔的摩市四个参与研究的阿片类物质治疗项目（OTP）之一开始新治疗阶段的两周内招募240名个体。符合条件的成年人在入组时必须报告过去30天内使用过可卡因和阿片类物质。参与者被随机分配接受常规治疗（TAU）或TAU加DynamiCare应急管理（DCM）应用程序。DCM应用程序为领取美沙酮剂量、完成认知行为疗法教育模块以及在随机安排的自我管理和经过验证的口服液体药物检测中可卡因或阿片类物质检测呈阴性提供小额金钱奖励。主要结局是美沙酮治疗中的留存率。在基线、3个月、6个月和12个月时对参与者进行评估，评估内容包括物质使用和生活质量，并且对DCM组的一部分参与者进行定性访谈，以评估干预措施的可接受性和实用性。根据美国国立卫生研究院的政策，该试验于2023年2月23日在国家临床试验数据库中注册（https://clinicaltrials.gov/study/NCT05766631）。
该项目将为许多物质使用障碍患者（尤其是那些使用可卡因的患者）的美沙酮维持治疗的辅助内容提供信息。该研究的设计将提供有关数字方式提供的CM有效性的科学有效信息，而参与者的应用程序使用数据和定性数据将是解释结局结果的丰富资源。CM是唯一已知的针对兴奋剂障碍的循证治疗方法，数字方式提供可以解决许多阻碍CM广泛应用的实际问题。因此，该研究可能会对科学和公共卫生产生重要影响。
