Dry extract from Psilocybe cubensis (15-25:1), extraction solvent: methanol for Cocaine use disorder

Inclusion criteria

• {"criterion_text":"- DSM-5 cocaine use disorder (powder/intranasal, at least moderate)\n- Negative urine test for cocaine at least the day before psilocybin dosing and on dosing day\n- Availability of a friend or family member into whose care the participant can be released following their psilocybin administration session and ensures they return home safely after the psilocybin administration session\n- Female subjects' serum pregnancy test performed at the screening visit and urine pregnancy test performed at the baseline visit must be negative.\n- If female of childbearing potential, are willing to use approved form of contraception (contraception pills, intrauterine device, bilateral tubal occlusion) from screening until study completion\n- Seeking treatment\n- ≥4 on the Severity of Dependence Scale\n- Cocaine use on at least 4 separate days in the past month\n- Aged 21-65 years at the time of signing informed consent\n- Able to give informed written consent\n- Able to speak English\n- Clinically acceptable laboratory and ECG findings"}

Exclusion criteria

• {"criterion_text":"- DSM-5 diagnoses (ascertained by the MINI V.7.0 and confirmation by a psychiatrist) of bipolar affective disorder type 1 or type 2, any psychotic disorder\n- Psychedelic use within the last 12 months\n- ≥ 25 lifetime uses of Psychedelics\n- Other personal circumstances and behaviour judged to be incompatible with the establishment of rapport or safe exposure to psilocybin\n- Active legal problems with the potential to result in incarceration\n- Psychological/behavioural therapies that have been initiated within 30 days prior to screening and/or will not remain stable for the duration of the study.\n- General Medical Exclusion Criteria (refer to protocol)\n- Dementia\n- First degree relatives with psychotic disorders\n- Current suicidal or homicidal ideation\n- Exhibiting significant suicide risk, as defined by: suicidal ideation as indicated by items 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) within the past six months, at Screening, during the Screening Period, or the day before dosing; demonstrating suicidal behaviours or non-suicidal self-injury within the past six months, or; clinical assessment of significant suicidal risk or risk of self-injury during participant interview\n- Psychiatric inpatient within the past six months prior to screening\n- Current severe Alcohol use disorder (DSM-5) (ascertained by the MINI V.7.0)\n- Current heroin use\n- Tricyclic antidepressants, lithium, MAO-Is, antipsychotics, (greater than 25% of the max recommended dose), Aldehyde dehydrogenase (ALDH) inhibitors, Alcohol dehydrogenase (ADH) inhibitors, Uracil-DNA Glycosylase (UDG)"}

Primary endpoints

• {"endpoint_text":"- 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","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- 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).","definition_or_measurement_approach":"Percentage of days abstinent measured by Timeline Followback self-report and urine drug test; sustained/complete abstinence defined as participants reporting complete abstinence from cocaine from the psilocybin administration session; time to first relapse assessed by Timeline Followback and urine or dropout; cocaine craving measured by CCQ-Brief; mood/anxiety by DASS-21; functionality by Sheehan Disability Scale and EQ-5D-5L; psychedelic experience by 5D-ASC and CEQ; treatment expectancy by SETS; blinding assessment as stated."}
• {"endpoint_text":"- 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).","definition_or_measurement_approach":"AEs and SAEs recorded per standard safety reporting; ECG monitored for ischemia, MI, QTc thresholds (>450 ms men, >470 ms women); BP and HR measured 15 minutes before dosing and at 1, 3, and 6 hours post-dose; laboratory tests include full blood count, liver function tests, urea and electrolytes."}

Ireland

Earliest CTIS Part Ii Submission Date

28-01-2026

Latest Decision Or Authorization Date

27-02-2026

Processing Time Days

30

Number Of Sites

2

Number Of Participants

24

Primary sponsor

Full Name

Trinity College Dublin

Organisation Type

Educational Institution

Country Of Registered Address

Ireland