Role of Experience, Conscious Awareness, and Plasticity in Psilocybin's Behavioral Effects - Follow-Up Study (The RECAP 2 Study)
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in Warwick-Edinburgh Mental wellbeing Scale (WEMWBS)
研究概览
简要总结
The goal of this clinical trial is to learn about the role that inducing neuroplasticity (the brain's ability to adapt and change) plays in the behavioral effects of psilocybin in people who have experienced a mild decline in emotional wellbeing.
Researchers will compare different doses of psilocybin combined with midazolam or placebo to see what dose induces increased wellbeing.
Participants will:
- Receive one of four possible combinations of medications
- Undergo an MRI
- Complete questionnaires
- Undergo transcranial magnetic stimulation (TMS) and EEG
详细描述
The purpose of this study is to investigate the role that inducing neuroplasticity plays in the behavioral effects of psilocybin in people with modest decrements in emotional wellbeing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 to 65 years at screening, of any identified gender and racial/ethnic group
- •Physically healthy; does not meet criteria for an exclusionary medical condition
- •English-speaking (able to provide consent and complete questionnaires)
- •Modest decrement in self-reported wellbeing without the presence of a DSM-5 Axis I mood or anxiety disorder
- •Able to undergo magnetic resonance imaging (MRI) and transcranial magnetic stimulation (TMS)
排除标准
- •Exclusionary DSM-5 psychiatric diagnosis and/or active suicidal ideation
- •Exclusionary medical conditions
- •Clinically significant safety lab abnormalities (i.e., Complete Blood Count with Differential, Comprehensive Metabolic Panel, and urinalysis)
- •Clinically significant electrocardiogram (ECG)
- •Use of psychotropic or CNS-altering medications within 3 months of screening
- •Hypertension or tachycardia
研究组 & 干预措施
Group 2: Psilocybin and IV saline
Psilocybin (25 mg) + IV saline (placebo for midazolam)
干预措施: Saline (Drug)
Group 3: Psilocybin and IV midazolam
Psilocybin (1 mg/control) + IV midazolam
干预措施: Psilocybin (Drug)
Group 4: Psilocybin and IV saline
Psilocybin (1 mg/control) + IV saline
干预措施: Psilocybin (Drug)
Group 4: Psilocybin and IV saline
Psilocybin (1 mg/control) + IV saline
干预措施: Saline (Drug)
Group 1: Psilocybin and intravenous (IV) midazolam
Psilocybin (25 mg) + IV midazolam
干预措施: Psilocybin (Drug)
Group 1: Psilocybin and intravenous (IV) midazolam
Psilocybin (25 mg) + IV midazolam
干预措施: Midazolam (Drug)
Group 3: Psilocybin and IV midazolam
Psilocybin (1 mg/control) + IV midazolam
干预措施: Midazolam (Drug)
Group 2: Psilocybin and IV saline
Psilocybin (25 mg) + IV saline (placebo for midazolam)
干预措施: Psilocybin (Drug)
结局指标
主要结局
Change in Warwick-Edinburgh Mental wellbeing Scale (WEMWBS)
时间窗: Baseline to 7 days post-dose
WEMWBS is a 14-item questionnaire in which participants describe their experience of each item. It is scored on a 5-point Likert scale, possible range of 14-70 where higher scores indicate higher levels of wellbeing.
Change in Brief Experiential Avoidance Questionnaire (BEAQ)
时间窗: Baseline to 7 days post-dose
The BEAQ is a 15-item questionnaire assessing participants agreement with wellbeing statements. It is scored on a 6-point Likert scale, ranging from 15-90 with higher scores indicating a greater tendency towards experiential avoidance
Change in transcranial magnetic stimulation evoked potential (TEP) amplitude
时间窗: Baseline to 7 days post-dose
TEP measures neural excitability in the stimulated region of the brain.
Change in Probabilistic Reversal Learning (PRL)
时间窗: Baseline to 7 days post-dose
Participants are presented with two stimuli or options and learn which one is more likely to be associated with a reward based on feedback after each trial. After a certain number of trials, the reward contingencies are reversed, meaning the previously advantageous option becomes less likely to be rewarded, and vice versa. The task assesses how quickly and effectively individuals can adapt to these changes in reward contingencies. Researchers analyze various performance metrics, such as the speed of reversal, the number of errors, and the patterns of choices (e.g., win-stay, lose-shift).
Change in Warwick-Edinburgh Mental wellbeing Scale (WEMWBS)
时间窗: Baseline to 7 days post-dose
WEMWBS is a 14-item questionnaire in which participants describe their experience of each item. It is scored on a 5-point Likert scale, possible range of 14-70 where higher scores indicate higher levels of wellbeing.
Change in Brief Experiential Avoidance Questionnaire (BEAQ)
时间窗: Baseline to 7 days post-dose
The BEAQ is a 15-item questionnaire assessing participants agreement with wellbeing statements. It is scored on a 6-point Likert scale, ranging from 15-90 with higher scores indicating a greater tendency towards experiential avoidance
Change in transcranial magnetic stimulation evoked potential (TEP) amplitude
时间窗: Baseline to 7 days post-dose
TEP measures neural excitability in the stimulated region of the brain.
次要结局
- Change in TEP amplitude(Baseline to 28 days post-dose)
- Altered States of Consciousness (ASC) questionnaire(Dosing 1 day)
- Emotional Breakthrough Inventory (EBI)(Dosing 1 day)
- Psychological Insight Questionnaire (PIQ)(Dosing 1 day)
- Change in WEMWBS(Baseline to 28 days post-dose)
- Change in BEAQ(Baseline to 28 days post-dose)
- Change in PRL(Baseline to 28 days post-dose)
- Change in TEP amplitude(Baseline to 28 days post-dose)
- Altered States of Consciousness (ASC) questionnaire(Dosing 1 day)
- Emotional Breakthrough Inventory (EBI)(Dosing 1 day)
- Psychological Insight Questionnaire (PIQ)(Dosing 1 day)