Decentralized clinical trial of contingency management digital therapeutic to treat stimulant use disorder

Abstract With no FDA-approved medications available to address stimulant use disorders (StUD) and rising prevalence of stimulants nationally, contingency management (CM) has gained attention as one of few effective treatment options. Despite growing clinical interest in CM, implementation barriers pose substantial challenges to moving this evidence-based intervention into routine use. Chief among these concerns is lack of reimbursement pathways and difficulty implementing CM with fidelity (Rash et al., 2012, 2020). Prescription Digital Therapeutics, mobile app based products that are FDA-cleared for the treatment of disease, have shown promise in overcoming reimbursement challenges by taking advantage of existing formulary billing pathways for drugs and medical devices. Also, delivery of CM through an app addresses many of the barriers of day-to-day implementation within the clinical workflow, maintains protocol adherence, and improves patient access–making it more likely to be adopted and impactful. Therefore, DynamiCare Health has developed and piloted DCH-003, a digital therapeutic delivering CM and other evidence-based modalities for the treatment of StUD. Unlike competitor products that include CM such as the PDT reSET from Pear Therapeutics, DCH-003 fully automates CM through remote, random, self-administered rapid saliva tests witnessed over selfie video, and is designed as a full year program (vs. 90 days). DCH-003 also incorporates evidence-based, self-guided therapy modules, appointment tracking, and delivers rewards via a risk-protective smart debit card. The product promises greater accessibility and fidelity to CM, and ultimately greater impact on StUD than currently available treatments. This study proposes a Phase II, two-group, randomized clinical trial (RCT) that will provide the necessary efficacy data in order to seek FDA clearance of DCH-003 for the treatment of StUD. Patients with StUD (N = 270) will be randomized to: a) Intervention: standard clinic care plus DCH-003 or b) Control: standard clinic care plus a time- and effort-controlled sham digital app (to control for placebo effect). The primary outcome will be the percent stimulant abstinent samples collected during weeks 1-38. Secondary outcomes include other clinically relevant indicators (abstinence from other illicit substances, treatment retention, long-term (weeks 39-64) percent negative samples). Aim 1 compares DCH-003 to sham control, and we expect better clinical outcomes in the intervention vs. control group. Aim 2 compares healthcare utilization and costs between the groups, with the goal of payer adoption post-FDA-clearance. Importantly, this study will be the first RCT for DCH-003 (essential for FDA clearance), and, more broadly, it addresses a critical next step in the translation of science to clinical practice that is vital for driving adoption of this proven, effective paradigm into routine care amidst a U.S. stimulant epidemic.