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临床试验/NCT03050541
NCT03050541已完成不适用

The Effects of 3,4-methylenedioxy-N-methylamphetamine (MDMA) on Encoding, Consolidation, and Retrieval of Emotional and Social Memories

University of Chicago0 个研究点目标入组 84 人开始时间: 2014年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
84
主要终点
Probability of Accurately Recalling Visual Stimuli

研究概览

简要总结

The purpose of this study is to examine the effects of MDMA on encoding and retrieval of emotional and social memories in healthy young adults. The study will explore the effects on memory retrieval when the drug is administered 1) before encoding, and 2) before retrieval.

详细描述

Here, we aim to investigate the effects of MDMA (1 mg/kg) on the encoding and retrieval of positive, negative, social, and neutral memories. The study will use a between subjects design with three groups (N = 20 per group). Two of the groups will be randomly assigned to receive MDMA before one of the two stages of memory: Encoding (ENC) or Retrieval (RET). The third group will receive placebo only (PLC). All three groups will receive capsules before viewing the study materials, and at retrieval two days later, but they will receive MDMA only in the capsule appropriate to their condition, and other capsules will contain placebo.

Participants will participate in two sessions: a viewing session during which they will view emotional and neutral stimuli, followed 48 hours later by a retrieval session, during which there will be a surprise memory test with two components (verbally cued recollection and picture recognition). On all sessions subjects will also complete mood questionnaires.

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, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Normal healthy males and females, aged 18-40 years.

排除标准

  • any current medical condition requiring medication or abnormal electrocardiogram
  • current or past medical condition considered to be a contraindication for the study conditions
  • any current Axis I psychiatric disorder (APA, 1994) including Substance Use Disorder, or Anxiety Disorder or Major Depression in the past year, any history of psychosis
  • less than high school education
  • lack of fluency in English
  • night shift work
  • pregnancy, lactation, or plans to become pregnant
  • use of hormonal contraception

研究组 & 干预措施

MDMA at Memory Encoding

Experimental

20 healthy adult volunteers will be randomly assigned to the encoding group (MDMA at Encoding). This group will receive capsules before viewing the study materials, and at retrieval two days later, but they will receive MDMA only in the capsule appropriate to their condition, and the next session capsule will contain placebo.

干预措施: MDMA (Drug)

MDMA at Memory Encoding

Experimental

20 healthy adult volunteers will be randomly assigned to the encoding group (MDMA at Encoding). This group will receive capsules before viewing the study materials, and at retrieval two days later, but they will receive MDMA only in the capsule appropriate to their condition, and the next session capsule will contain placebo.

干预措施: Placebo (Drug)

MDMA at Memory Retrieval

Experimental

20 healthy adult volunteers will be randomly assigned to the retrevial group (MDMA at Retrevial). This group will receive placebo before viewing the study materials, and MDMA at retrieval two days later..

干预措施: MDMA (Drug)

MDMA at Memory Retrieval

Experimental

20 healthy adult volunteers will be randomly assigned to the retrevial group (MDMA at Retrevial). This group will receive placebo before viewing the study materials, and MDMA at retrieval two days later..

干预措施: Placebo (Drug)

Placebo at both sessions

Placebo Comparator

20 healthy adult volunteers will be randomly assigned to the placebo group (no drug at either session). This group will receive only placebo during study, session before viewing the study materials, and at retrieval two days later.

干预措施: Placebo (Drug)

结局指标

主要结局

Probability of Accurately Recalling Visual Stimuli

时间窗: 90 minutes into Session 2

During encoding, participants were presented with labels that were sometimes followed by pictures. During the first memory test, participant were presented again with all of the labels and asked, "Did you see this picture?" Hit and false alarm rates were then calculated, and memory accuracy was measured by hits minus false alarms.

次要结局

  • Probability of Accurately Recognizing Visual Stimuli(90 minutes into Session 2)

研究者

申办方类型
Other
责任方
Sponsor

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Effects of MDMA on Emotional and Social Memories | 临床试验