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

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-515147-32-02

Enrollment

Registered

2026-02-27

Start date

Unknown

Completion date

Unknown

Last updated

2026-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cocaine addiction

Brief summary

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

Detailed description

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).

Interventions

DRUGNytol One-A-Night 50 mg Tablets

DRUGPSILOCYBIN (PEX010)

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
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	—

Secondary

Measure	Time frame
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).	—

Measure

Time frame

—

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 28, 2026