POSITRON - PsilOcybin with pSychologIcal supporT foR cOcaiNe: a randomised controlled pilot feasibility trial of psilocybin with psychological support for cocaine use disorder

Condition studied

Cocaine addiction

Investigational medicinal product(s)

Eligibility

Primary endpoint

To assess feasibility of the clinical trial using psilocybin 25mg versus diphenhydramine 100mg (1:1) for the following: Recruitment methods and rate, Rate of willingness to be randomised, Randomisation, Adherence to follow-up, Reasons for drop-out from treatment and follow-up

Endpoint detail

Outcomes include: percentage of days abstinent (Timeline Followback & urine), sustained abstinence, time to relapse, cocaine craving (CCQ-Brief), mood/anxiety (DASS-21), functionality (Sheehan, EQ-5D-5L), psychedelic experience (5D-ASC, CEQ), treatment expectancy (SETS), blinding assessment, and meaning in life (MLQ)., Safety outcomes include: number of AEs and SAEs, ECG abnormalities (e.g., ischemia, MI, QTc >450ms for men, >470ms for women), clinically significant changes in blood pressure and heart rate during dosing (pre-dose, 1h, 3h, 6h), and lab tests (FBC, LFTs, U&E).