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POSITRON - PsilOcybin with pSychologIcal supporT foR cOcaiNe: a randomised controlled pilot feasibility trial of psilocybin with psychological support for cocaine use disorder
EU CTIS ID: 2024-515147-32-02
What this study is testing
The primary objective is to assess the feasibility of a trial of psilocybin with psychological support for the treatment of DSM-5 powder/intranasal cocaine use disorder (CUD) by conducting a randomised double-blind controlled pilot trial of a single dose of psilocybin (25mg) versus diphenhydramine 100mg (1:1) with 6 sessions of psychological support, to inform a future definitive trial.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- DSM-5 cocaine use disorder (powder/intranasal, at least moderate)
- Negative urine test for cocaine at least the day before psilocybin dosing and on dosing day
- 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
- Female subjects' serum pregnancy test performed at the screening visit and urine pregnancy test performed at the baseline visit must be negative.
- 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
- Seeking treatment
You likely can't join if
- 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
- Psychedelic use within the last 12 months
- ≥ 25 lifetime uses of Psychedelics
- Other personal circumstances and behaviour judged to be incompatible with the establishment of rapport or safe exposure to psilocybin
- Active legal problems with the potential to result in incarceration
- 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.
See the full eligibility criteria
- DSM-5 cocaine use disorder (powder/intranasal, at least moderate)
- Negative urine test for cocaine at least the day before psilocybin dosing and on dosing day
- 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
- Female subjects' serum pregnancy test performed at the screening visit and urine pregnancy test performed at the baseline visit must be negative.
- 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
- Seeking treatment
- ≥4 on the Severity of Dependence Scale
- Cocaine use on at least 4 separate days in the past month
- Aged 21-65 years at the time of signing informed consent
- Able to give informed written consent
- Able to speak English
- Clinically acceptable laboratory and ECG findings
- 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
- Psychedelic use within the last 12 months
- ≥ 25 lifetime uses of Psychedelics
- Other personal circumstances and behaviour judged to be incompatible with the establishment of rapport or safe exposure to psilocybin
- Active legal problems with the potential to result in incarceration
- 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.
- General Medical Exclusion Criteria (refer to protocol)
- Dementia
- First degree relatives with psychotic disorders
- Current suicidal or homicidal ideation
- 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
- Psychiatric inpatient within the past six months prior to screening
- Current severe Alcohol use disorder (DSM-5) (ascertained by the MINI V.7.0)
- Current heroin use
- 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)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.