Safety Profile of 25 mg Psilocybin in Individuals With Cocaine Use Disorder
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Heart rate
研究概览
简要总结
The purpose of this study is to establish the safe administration of psilocybin in individuals with cocaine use disorder in terms of cardiovascular (e.g., heart rate) and subjective (e.g., mood) effects. The study's subject population consists of men and women between the ages of 21 and 55 from the Los Angeles area that meet criteria for cocaine use disorder and express an interest in ceasing cocaine use. 25 mg oral psilocybin will be administered to 10 individuals (separately) during a single laboratory visit. The laboratory visit will take place from 9 am until 3 pm within a comfortable, living room like environment. Within this study session room, participants will be accompanied by two clinicians. Participants will then consume the psilocybin capsule, and thereafter will be encouraged to lie down on a couch and introspect on the experience. At one-hour intervals following ingestion, participants will be tested briefly for changes in heart rate, blood pressure, and subjective effects. No blood draws, behavioral assessments, or neuroimaging is included in the study. Following the laboratory visit, investigators will check-in on participants remotely, after 48 hours, and 10, 50, and 90 days from the psilocybin session.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Have a Body Mass Index from 18.5 - 34kg/m^2
- •Score of at least 3 on the Severity of Dependence Scale
- •Desire to cease cocaine use as indicated by a goal of complete cocaine abstinence on the Thoughts about Abstinence Questionnaire
- •At least 1, but not more than 10 total lifetime use of a classical psychedelic (5-HT2a agonist)
- •0 use of a classical psychedelic in the last year
排除标准
- •History of serious adverse events in response to classical psychedelics including history of Hallucinogen Persisting Perceptive Disorder
- •Abnormal electrocardiogram based on testing at study entrance
- •A resting heart rate greater than 90 bpm
- •Current hypertension (exceeding 140 systolic and 90 diastolic at resting)
- •Current use of antidepressants or other serotonergic-affecting substances
- •History of cardiac conditions
- •History of hepatic or renal impairments
- •History of stroke or Transient Ischemic Attack
- •Epilepsy or history of seizures
- •Immediate family or personal history of psychosis, bipolar disorder, or schizophrenia
- •Anxiety or mood disorders determined by the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-V)
- •Must not meet DSM-V criteria for any substance use disorders other than cocaine, caffeine, or nicotine
- •Must not meet DSM-V criteria for borderline personality or dissociative disorders
- •Current suicidal ideation or lifetime history of suicide attempts
- •Arrest for a violent offense
- •Any clinical condition, history of illness, or laboratory results that may place participants at greater risk as judged by the study physician
- •Women will not be eligible if trying to get pregnant, pregnant, or lactating
研究组 & 干预措施
Psilocybin
25 mg psilocybin
干预措施: Psilocybin (Drug)
结局指标
主要结局
Heart rate
时间窗: From pre-dose through one-hour intervals post-dose until heart rate has returned to within 20% of the pre-dose measure, or after a minimum of 6 hours.
Beats per minute measured with blood pressure monitor.
Blood pressure
时间窗: From pre-dose through one-hour intervals post-dose until blood pressure has returned to within 20% of the pre-dose measure, or after a minimum of 6 hours
Systolic and diastolic blood pressure measured with blood pressure monitor.
Self-reported drug effects
时间窗: From pre-dose through one-hour intervals post-dose over a 6-bour period.
Average and peak subjective ratings of drug effects associated with mood measured using visual analogue scales (VAS; 1-100 mm).
次要结局
- Self-reported cocaine craving(48 hours and 10, 50, and 90 days after psilocybin administration.)
- Self-reported mood ratings(48 hours and 10, 50, and 90 days after psilocybin administration.)
研究者
Conor Murray
Principal Investigator
University of California, Los Angeles