Evaluation of 3,4-methylenedioxymethamphetamine (MDMA) on Startle Response
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- EMG of right orbicularis oculi muscle
研究概览
简要总结
The goal of this clinical trial is to learn if MDMA impacts startle response in healthy participants.
The main question it aims to answer is: Does MDMA impact participant's performance on a startle test?
Researchers will compare healthy volunteers who have taken MDMA to those who have taken placebo.
Participants will first undergo a 1-hour startle test. The next day, they will be randomized to receive either MDMA or placebo followed by another startle test and vitals signs and blood measurements. Participants will return the next day for a final startle test. Their sleep will be tracked by a Fitbit device.
详细描述
This is a randomized, blinded, placebo-controlled Phase 1 study that aims to evaluate the impact of 3,4-methylenedioxymethamphetamine (MDMA) on startle response.
This study will enroll healthy participants. At Visit 1, all participants will undergo a 1-hour startle test. Acoustic startle will be measured through assessing eye-blink response from the orbicularis oculi muscles in response to a 106 dB noise, using sensors under the eye. While watching the computer monitor, the participant will also experience several brief blasts of air directed at the throat.
At Visit 2 (24 hours later), participants will be randomized to receive 100 mg of MDMA or inactive placebo, after which they will undergo another startle test. Participants enrolled in the study who agree to do this will have their blood drawn to measure levels of oxytocin, and possibly other hormones or proteins, such as cortisol or brain-derived neurotrophic factor (BDNF). Measuring oxytocin will be blind to condition, and the decision will happen before randomization to either condition. Blood will be drawn before MDMA or placebo administration, and eight times afterwards.The researchers will measure pulse, blood pressure and temperature once before and six times after receiving MDMA or placebo, and study participants will complete a questionnaire about their experience.
At Visit 3, participants will return for a final startle test and recall task. Sleep will be measured via self-report and Fitbit during study participation.
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
- Double (Participant, Investigator)
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
- •Persons aged 21 to
- •Ability to visually read and understand English language.
- •Live within in metro Atlanta area
- •Previously used MDMA in a recreational or research setting
- •If a person is of childbearing potential (able to bear children), they must have a negative pregnancy test at study entry and prior to the Experimental Session. They must agree to use adequate birth control through 10 days after the last dose of MDMA. Adequate birth control methods include intrauterine device (IUD), injected or implanted hormonal methods, abstinence, oral hormones plus a barrier contraception or double barrier contraception. Two forms of contraception are required with any barrier method or oral hormones (i.e. condom plus diaphragm, condom or diaphragm plus spermicide, oral hormonal contraceptives plus spermicide or condom). Not of childbearing potential is defined as permanent sterilization, postmenopausal, or male.
- •(For sub-study measuring serum oxytocin) Willing to have periodic blood draws
排除标准
- •Upon review of medical or psychiatric history, have any current or past diagnosis that would be considered a risk to participating in the study.
- •Are abusing illegal drugs.
- •Current use of any psychoactive medications, including antidepressants, mood stabilizers, sedatives, stimulants, antipsychotics, anxiolytics, or beta-blockers
- •Are not able to give adequate informed consent.
- •Uncontrolled hypertension, or clinically significant cardiac arrhythmia, as detected by electrocardiogram.
- •Currently pregnant or breast-feeding.
- •History of acute angle glaucoma.
- •Hearing impairment as assessed by audiometer; unable to detect tones below 40 dB in right or left ear.
研究组 & 干预措施
100 mg MDMA HCl
Participants receive 100 mg MDMA HCl on their second visit
干预措施: Midomafetamine (Drug)
100 mg MDMA HCl
Participants receive 100 mg MDMA HCl on their second visit
干预措施: Acoustic startle (Behavioral)
Placebo
Participants receive inactive placebo on their second visit
干预措施: Placebo (Drug)
Placebo
Participants receive inactive placebo on their second visit
干预措施: Acoustic startle (Behavioral)
结局指标
主要结局
EMG of right orbicularis oculi muscle
时间窗: Four days post-enrollment
Description: Measure of startle response to noise after fear extinction training
次要结局
- Body temperature 4 hours post-drug(4 hours post-drug)
- Body temperature 5 hours post-drug(5 hours post-drug)
- Body temperature 6 hours post-drug(6 hours post-drug)
- Plasma oxytocin (OT) levels predrug(5 min prior to drug administration)
- Systolic blood pressure 1 h 15 min post-drug(1 hour 15 minutes post drug)
- Plasma oxytocin (OT) levels 5 min post-drug(5 min post-drug administration)
- Plasma oxytocin (OT) levels 20 min post-drug(20 min post-drug administration)
- Plasma oxytocin (OT) levels 95 min post-drug(95 min post-drug administration)
- Plasma oxytocin (OT) levels 110 min post-drug(110 min post-drug administration)
- Systolic blood pressure 5 h post-drug(5 hours post-drug)
- Plasma oxytocin (OT) levels 185 min post-drug(185 min post-drug administration)
- Plasma oxytocin (OT) levels 200 min post-drug(200 min post-drug administration)
- Plasma oxytocin (OT) levels 240 min post-drug(240 min post-drug administration)
- Systolic blood pressure 6 h post-drug(6 hours post-drug)
- Diastolic blood pressure pre-drug(5 minutes pre-drug)
- Diastolic blood pressure 45 min post-drug(45 minutes post-drug)
- Diastolic blood pressure 1 h 15 min post-drug(1 hour 15 minutes post-drug)
- Diastolic blood pressure 1 h 45 min post-drug(1 hour 45 minutes post drug)
- Diastolic blood pressure 3 h post-drug(3 hours post-drug)
- Diastolic blood pressure 4 hours post-drug(4 hours post-drug)
- Diastolic blood pressure 5 hours post-drug(5 hours post-drug)
- Diastolic blood pressure 6 hours post-drug(6 hours post-drug)
- Pulse pre-drug(5 minutes pre-drug)
- Pulse 45 min post-drug(45 minutes post-drug)
- Pulse 1 h 15 min post-drug(1 hour 15 minutes post-drug)
- Pulse 5 h post-drug(5 hours post-drug)
- Body temperature 3 hours post-drug(3 hours post-drug)
- Pulse 1 h 45 min post-drug(1 hour 45 minutes post-drug)
- Pulse 3 h post-drug(3 hours post-drug)
- Pulse 4 h post-drug(4 hours post-drug)
- Pulse 6 h post-drug(6 hours post-drug)
- Body temperature pre-drug(5 minutes pre-drug)
- Body temperature 45 minutes post-drug(45 minutes post-drug)
- Body temperature 1 h 15 minutes post-drug(1 hour 15 minutes post-drug)
- Body temperature 1 h 45 minutes post-drug(1 hour 45 minutes post-drug)
- Systolic blood pressure 45 min post-drug(45 minutes post-drug)
- Systolic blood pressure pre-drug(5 minutes pre-drug)
- Systolic blood pressure 3 h post-drug(3 hours post-drug)
- Systolic blood pressure 4 h post-drug(4 hours post-drug)
- Systolic blood pressure 1 h 45 min post-drug(1 hour 45 minutes post drug)
- Plasma oxytocin (OT) levels 300 min post-drug(300 min post-drug administration)