KAP for Depression in Abstinent Opioid Users (KReDO)
Terminated single-group Phase II study (n=5) of intramuscular ketamine (0.5→1.5 mg/kg, up to 60 mg) weekly for 8 weeks with psychotherapy for adults (18–64) with MDD and opioid use disorder in remission.
Details
This single-group Phase II study evaluated ketamine-assisted psychotherapy in adults with major depressive disorder and opioid use disorder in early or sustained remission. Participants received eight weekly intramuscular ketamine sessions (starting 0.5 mg/kg with escalation to 1.5 mg/kg or a 60 mg cap) paired with psychotherapy before, during and after dosing.
Eligibility required MADRS ≥20 and stability on other psychotropic medications; primary outcomes included depression symptom change and safety/tolerability measured across a 16-week participation period including follow-up.