Randomised, double-blind, parallel-group Phase II trial (n=40) comparing a single oral psilocybin dose (0.36 mg/kg) versus diphenhydramine 100 mg with CBT-based preparation and integration in adults seeking to stop cocaine use; includes MRI assessments.
Randomised, quadruple-blind, parallel-group trial (n=40) testing psilocybin (0.36 mg/kg oral, single 8-hour session) against an active comparator (diphenhydramine 100 mg) for treatment of cocaine use disorder with CBT-based preparation and integration.
Unique features include pre- and post-treatment 3T MRI and MRS to assess changes in default mode network connectivity and Glx in the anterior cingulate cortex and hippocampus as potential mediators of clinical effects.
Participants receive four weekly 2-hour preparation CBT sessions, the dosing session with two therapists present, an ~1-hour meeting within 2 days for initial integration and safety assessment, then weekly 1-hour integration sessions for four weeks, plus 3- and 6-month follow-ups.
Single oral psilocybin session (0.36 mg/kg) with preparatory CBT and integration.
Single oral dose administered during an 8-hour session; paired with CBT preparation and integration.
Active placebo comparator: oral diphenhydramine 100 mg in single session.
Diphenhydramine 100 mg oral (active comparator / control).