Ketamine-Assisted Recovery (KARE): protocol for an open-label pilot trial of ketamine-assisted psychotherapy for publicly insured patients with methamphetamine use disorder and HIV risks
BMJ Open August 1, 2025 Nicky J. Mehtani, B. Anderson, Irina Alexander et al.
Methamphetamine use disorder (MeUD) has no FDA-approved pharmacotherapies and is linked to poor neurological, psychiatric, and cardiovascular outcomes, especially among low-income populations, while also increasing risks for sexually transmitted infections. The Ketamine-Assisted Recovery (KARE) trial is an open-label pilot study enrolling 12 to 24 Medicaid- or Medicare-insured adults with moderate-to-severe MeUD and HIV risk factors. Participants will receive three intramuscular ketamine sessions (0.50-0.75 mg/kg) combined with seven motivational enhancement therapy sessions over five weeks. The study will assess feasibility, acceptability, tolerability, safety, and potential mechanisms such as psychological flexibility, laying groundwork for future randomized trials.