NCT02971605已完成1 期
Measurement of Persisting Changes in Emotional Brain Functioning Produced by Psilocybin
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
- 13
- 试验地点
- 1
- 主要终点
- Amygdala Response to Stimuli in the Emotion Recognition Test
研究概览
简要总结
The proposed pilot study will assess whether ingestion of a classic hallucinogen (psilocybin) leads to changes in emotion processing and neural circuitry that may predict repeated self-administration of this drug and underlie an atypical mechanism of abuse liability, which may vitally contribute to the understanding of the potential for abuse and the underlying mechanisms supporting abuse of classic hallucinogens.
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
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Have given written informed consent
- •Have at least a high-school level of education or equivalent, and be fluent in English
- •Be healthy and psychologically stable as determined by screening for medical and psychiatric problems via a personal interview, a medical questionnaire, a physical examination, an electrocardiogram (ECG), and routine medical blood and urinalysis laboratory tests
- •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 morning of the drug session day. If the participant does not routinely consume caffeinated beverages, he/she must agree not to do so on the session day.
- •Agree to refrain from using any psychoactive drugs, including alcoholic beverages and nicotine, within 24 hours of each drug administration. The exception is caffeine.
- •Agree not to take any "as needed" medications on the mornings of drug sessions
- •Agree not to take sildenafil (Viagra®), tadalafil, or similar medications within 72 hours of each drug administration.
- •Agree that for one week before each drug session, he/she will refrain from taking any nonprescription medication, nutritional supplement, or herbal supplement except when approved by the study investigators. Exceptions will be evaluated by the study investigators and will include acetaminophen, non-steroidal anti-inflammatory drugs, and common doses of vitamins and minerals.
- •Have limited lifetime use of hallucinogens
排除标准
- •Women who are pregnant (as indicated by a positive urine pregnancy test assessed at intake and before each drug session) or nursing; women who are of child-bearing potential and sexually active who are not practicing an effective means of birth control.
- •Cardiovascular conditions: coronary artery disease, stroke, angina, uncontrolled hypertension, a clinically significant ECG abnormality (e.g., atrial fibrilation), artificial heart valve, or stroke in the past year
- •Epilepsy with history of seizures
- •Insulin-dependent diabetes; if taking oral hypoglycemic agent, then no history of hypoglycemia
- •Currently taking psychoactive prescription medication on a regular (e.g., daily) basis
- •Currently taking on a regular (e.g., daily) basis any medications having a primary centrally-acting serotonergic effect, including mono-amine oxidase inhibitors (MAOIs). For individuals who have intermittent or "as needed" use of such medications, psilocybin sessions will not be conducted until at least 5 half-lives of the agent have elapsed after the last dose.
- •More than 20% outside the upper or lower range of ideal body weight according to Metropolitan Life height and weight table
- •Current or past history of meeting Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) criteria for schizophrenia spectrum or other psychotic disorders (except substance/medication-induced or due to another medical condition), or Bipolar I or II Disorder
- •Current or past history within the last 5 years of meeting DSM-5 criteria for a moderate or severe alcohol or drug use disorder (excluding caffeine and nicotine)
- •Have a first or second-degree relative with schizophrenia spectrum or other psychotic disorders (except substance/medication-induced or due to another medical condition), or Bipolar I or II Disorder
- •Has a psychiatric condition judged to be incompatible with establishment of rapport or safe exposure to psilocybin
- •Head trauma
- •Claustrophobia incompatible with scanning
- •Cardiac pacemaker
- •Implanted cardiac defibrillator
- •Aneurysm brain clip
- •Inner ear implant
- •Prior history as a metal worker and/or certain metallic objects in the body -- must complete magnetic resonance imaging (MRI) screening form and be approved by MRI technologist before each scan
研究组 & 干预措施
Psilocybin
Experimental
Participants will be administered a 25 mg/70 kg dose of psilocybin
干预措施: Psilocybin (Drug)
结局指标
主要结局
Amygdala Response to Stimuli in the Emotion Recognition Test
时间窗: 1 day pre (baseline), 1 week post, and 1 month post session
Blood oxygenation level-dependent (BOLD) percent signal change in response to stimuli in the emotion recognition task was measured in the left and right amygdala.
次要结局
- Change in Longitudinal Emotion and Mood Questionnaire Scores(1 day pre (baseline), 1 week post, and 1 month post session)
- Change in Emotional Functioning Task Accuracy(1 day pre (baseline), 1 week post, and 1 month post session)
- Change in Emotional Functioning Tasks Response Time (Milliseconds)(1-day pre (baseline), 1-week post, 1-month post session)
研究者
研究点 (1)
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