Single-arm pilot feasibility trial (n=12) of intramuscular ketamine (0.50–0.75 mg/kg IM, 3 doses ~once weekly) combined with manualised psychotherapy (7 sessions) for publicly insured patients with moderate-to-severe methamphetamine use disorder who have or are at-risk for HIV.
Single-group, Phase II feasibility study (N=12) delivering three monitored IM ketamine doses (initial 0.50 mg/kg, subsequent 0.50 or 0.75 mg/kg as tolerated) approximately once weekly alongside seven manualised psychotherapy sessions over ~5 weeks to publicly insured patients with moderate-to-severe methamphetamine use disorder and HIV risk or diagnosis.
Outcomes include feasibility and acceptability, safety/tolerability, and changes in methamphetamine use measured daily pre-, during, and up to 3 months post-intervention with follow-up visits at 4 and 12 weeks.
3 IM ketamine administrations (~once weekly) combined with manualised psychotherapy (3 preparatory + 4 integration visits) over a ~5-week treatment period.
Initial 0.50 mg/kg; subsequent doses may be 0.50 or 0.75 mg/kg per tolerability.
Manualised psychotherapy: three 1-hour preparatory sessions, integration visit within 1–3 days after each ketamine session, plus a final 1-hour integration ~1 week after last session.