NCT00996411已完成1 期
Human Psychopharmacology of Salvinorin A
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Hallucinogen Rating Scale
研究概览
简要总结
This study is characterizing the subject-rated and behavioral effects of salvinorin A in healthy volunteers. The investigators hypothesize the salvinorin A will have hallucinogen-like effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Have given written informed consent
- •Have a high school level of education
- •Have a self-reported interest in spirituality and altered states of consciousness
- •Have used hallucinogens (e.g., LSD, psilocybin mushrooms, Salvia divinorum) including having used Salvia divinorum or salvinorin A by the inhalation route (i.e., volunteers without histories of Salvia divinorum or salvinorin A use by the inhalation route will be excluded)
- •Be 21 to 65 years old
- •Agree to consume approximately the same amount of caffeine-containing beverage (e.g., coffee, tea) that he/she consumes on a usual morning, before arriving at the research unit on the mornings of drug session days. If the volunteer does not routinely consume caffeinated beverages, he or she must agree not to do so on session days.
- •Agree to refrain from using any psychoactive drugs, including alcoholic beverages, within 24 hours of each drug administration. As described elsewhere, exceptions include daily use of caffeine.
- •Be healthy as determined by screening for medical problems via a personal interview, a medical questionnaire, a physical examination, an electrocarroutine medical blood and urinalysis laboratory tests.
排除标准
- •General Medical Exclusion Criteria
- •Cardiovascular conditions: uncontrolled hypertension, angina, a clinically significant ECG abnormality (e.g. atrial fibrillation), TIA in the last 6 months stroke, peripheral or pulmonary vascular disease
- •Epilepsy with history of seizures
- •Diabetes mellitus
- •Females who are pregnant (positive pregnancy test) or nursing, or are not practicing an effective means of birth control
- •Currently taking psychoactive prescription medication on a regular basis
- •More than 20% outside the upper or lower range of ideal body weight according to Metropolitan Life height and weight table
- •Psychiatric Exclusion Criteria
- •Current or past history of meeting DSM-IV criteria for Schizophrenia, Psychotic Disorder (unless substance-induced or due to a medical condition), or Bipolar I or II Disorder.
- •Current severe Obsessive-Compulsive Disorder, Dysthymic Disorder, or Panic Disorder.
- •Current or past history within the last 5 years of meeting DSM-IV criteria for alcohol or drug dependence (excluding caffeine and nicotine) or severe major depression.
- •Have a first or second degree relative with schizophrenia, psychotic disorder (unless substance induced or due to a medical condition), or bipolar I or II disorder.
- •Currently meets DSM-IV criteria for Dissociative Disorder, Anorexia Nervosa, Bulimia Nervosa, or other psychiatric conditions judged to be incompatible with establishment of rapport or safe exposure to salvinorin A.
研究组 & 干预措施
Salvinorin A
Experimental
干预措施: Salvinorin A (Drug)
结局指标
主要结局
Hallucinogen Rating Scale
时间窗: Approximately 1 hour after drug administration
次要结局
未报告次要终点
研究者
Roland Griffiths
Professor, Department of Psychiatry,
Johns Hopkins University
研究点 (2)
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