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Psilocybin for Opioid Use Disorder (OUD)

Not yet recruitingRegisteredCTG

Double-blind, adaptive, two-stage, multi-site, Phase II randomised trial (up to 480 consented to yield 240 randomized) comparing single moderate (20 mg) and high (30 mg) doses of oral psilocybin with low-dose (1 mg) control in OUD patients on methadone.

Details

Adaptive, parallel-group, double-blind Phase II trial randomising participants to single oral psilocybin doses (1 mg, 20 mg, 30 mg) with an interim analysis after Stage 1 to select arms for Stage 2.

Primary outcome is weeks of biologically-verified opioid abstinence over 24 weeks; safety, psychiatric measures, and machine-learning-based responder analyses are secondary aims. Participants remain under observation for 8 hours after dosing.

Topics:Opioid Use Disorder (OUD)

Registry

Registry linkNCT06796062