2024-515147-32-02招募中2 期
POSITRON - PsilOcybin with pSychologIcal supporT foR cOcaiNe: a randomised controlled pilot feasibility trial of psilocybin with psychological support for cocaine use disorder
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- 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
研究概览
简要总结
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.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
- •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)
结局指标
主要结局
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
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
次要结局
- 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).
研究者
Head of Clinical Sponsorship Oversight
Scientific
Trinity College Dublin
研究点 (2)
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