Telehealth-Delivered tDCS for Cannabis Addiction Recovery: The C.A.R.E.S. (Cannabis Addiction Recovery Enhancement Stimulation) Initiative

ABSTRACT Cannabis use in the U.S. has surged, driven by widespread legalization and accelerated by the COVID-19 pandemic. Over 55 million U.S. adults are current users, and approximately 30% will develop cannabis use disorder (CUD). Despite the urgent need for effective treatments, no FDA-approved options exist, and current interventions have proven insufficient, underscoring the necessity for innovative and accessible solutions. We propose a novel, home-based intervention combining transcranial direct current stimulation (tDCS) with mindfulness meditation, targeting the dorsolateral prefrontal cortex—a key region in the neural circuitry underlying the addiction cycle. Delivered via the ElectraRx telehealth portal, this approach is both cost-effective and widely accessible. Our extensive preliminary data, involving over 600 patients and 17,000 home-based tDCS sessions, along with our pilot study of this intervention in CUD, demonstrate its feasibility and potential. However, further development and testing are required to advance it to clinical use. The initial UG3 phase (Years 1-2) will involve developing a tDCS home-based administration system by Soterix Medical Inc. (SMI), tailored specifically for the intended population and environment ("ElectraRx-CARES"). We will then refine and validate the tDCS-mindfulness intervention through a double-blind, sham-controlled feasibility trial with n = 46 adults with CUD. If at least 50% of participants complete 70% of the sessions, we will advance to the UH3 phase, where a large-scale RCT enrolling n = 192 participants with CUD to assess the intervention's efficacy in reducing cannabis use and withdrawal symptoms. Follow-up assessments at three months will evaluate the persistence of these effects. FDA guidance on device development and data collection will be obtained throughout. Finally, we will optimize intervention delivery, iterate the device, and advance the regulatory process, including pursuing Breakthrough Device Designation. This scalable intervention addresses a critical public health need and represents a promising step forward in treating the rapidly growing problem of CUD.