A Phase 1 Placebo-Controlled, Double-Blind Crossover Study to Assess Psychological Effects of MDMA When Administered to Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 107
- 试验地点
- 3
- 主要终点
- Profile of Mood States (POMS)
研究概览
简要总结
The goal of this clinical trial is to study MDMA-assisted therapy in healthy volunteers. The main question it aims to answer is:
Do two sessions of MDMA-assisted therapy result in changes in mood, emotional closeness to self and others, and other psychological symptoms?
Researchers will compare MDMA-assisted therapy to placebo with therapy.
Participants will have a non-drug preparatory session prior to each experimental session and an integrative session after each experimental session. Participants who received MDMA will crossover to receive placebo and placebo participants will crossover to receive MDMA.
详细描述
This study is a Phase 1 study for up to a hundred people, The information gathered during this study may help us better understand the psychological effects produced by MDMA and how those effects can more effectively be used within a therapeutic context, as with people with PTSD. Participants will be healthy volunteers who have completed a program training them in conducting MDMA-assisted psychotherapy. In this randomized, double blind study, subjects will receive placebo and MDMA during two sessions scheduled at least two days apart in a psychotherapy setting. Mood, self-reported interpersonal closeness, psychological symptoms, blood pressure, heart rate and body temperature will be measured, and personality will be measured prior to the first therapy-like session and two months after the second session.
The study will follow a cross-over design, meaning that all participants will receive both MDMA and placebo, with order of session randomly assigned. Study participants will have a preparatory session prior to each experimental session and an integrative session after each session. The researchers will contact them via telephone one and two months after the second experimental session. By comparing changes in mood, feelings of emotional closeness to the self and others and psychological symptoms after placebo and after MDMA, the investigators hope to learn something about the effects of MDMA on mood, subjective experience and the way we think and feel about others.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Engaged in a sponsor-supported program for training therapists to perform MDMA-assisted psychotherapy research
- •Are at least 21 years old
- •Are willing to follow all rules and restrictions related to study participation, including restrictions on medication use for a week prior to experimental sessions and restrictions on food and alcohol consumption on the day prior to each experimental session
- •Are willing to remain overnight at the study site
- •Agree to have transportation other than driving themselves after the integrative session on the day after each experimental session
- •Are willing to be contacted via telephone for all necessary telephone contacts
- •If a woman of childbearing potential, must have a negative pregnancy test and agree to use an effective form of birth control
- •Are proficient in speaking and reading English
- •Agree to have all clinic visit sessions recorded to audio and video
排除标准
- •Are pregnant or nursing, or are women of child bearing potential who are not practicing an effective means of birth control
- •Weigh less than 48 kg
- •Have used "ecstasy" (material represented as containing MDMA) within 6 months of the MDMA session
- •Require ongoing therapy with a psychotropic drug
- •Meet DSM-V criteria for substance abuse or dependence for any substance
- •Unable to give adequate informed consent
- •Upon review of past and current drugs/medication must not be on or have taken a medication that is exclusionary
- •Upon review of medical or psychiatric history must not have any current or past diagnosis that would be considered a risk to participation in the study
研究组 & 干预措施
Lactose (Inactive Placebo)
Participant receives inactive placebo during day-long experimental session.
干预措施: Lactose (inactive placebo) (Drug)
3,4-methylenedioxymethamphetamine
Participant receives 120 mg midomafetamine HCl possibly followed by 40 mg midomafetamine HCl during a day-long experimental session.
干预措施: midomafetamine HCl (Drug)
结局指标
主要结局
Profile of Mood States (POMS)
时间窗: Day after each experimental session
Assesses current mood state
次要结局
- Interpersonal closeness measure(Day after each experimental session)
- Blood pressure (SBP/DBP)(Throughout each experimental session, every 15 minutes for 6 hours, then every 30 minutes for 2 hours)
- Heart rate (pulse)(Throughout each experimental session, every 15 minutes for 6 hours, then every 30 minutes for 2 hours)
- Brief Symptom Inventory (BSI)(Day after each experimental session)
- Columbia Suicide Severity Rating Scale (adapted C-SSRS)(Day of each experimental session approximately five to six hours after drug administration)
- Neuroticism Extroversion Openness Personality Inventory(Two months after the second experimental session)
- Body temperature(Approximately every 60 minutes for each experimental session)