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Trial record 6 of 64 for:    MDMA

Effects of MDMA on Emotional and Social Memories

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ClinicalTrials.gov Identifier: NCT03050541
Recruitment Status : Completed
First Posted : February 13, 2017
Results First Posted : June 29, 2018
Last Update Posted : June 29, 2018
Sponsor:
Information provided by (Responsible Party):
University of Chicago

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: MDMA Drug: Placebo Not Applicable

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Effects of 3,4-methylenedioxy-N-methylamphetamine (MDMA) on Encoding, Consolidation, and Retrieval of Emotional and Social Memories
Study Start Date : December 2014
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

Arm Intervention/treatment
Experimental: MDMA at Memory Encoding
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.
Drug: MDMA
This is a between subjects, double-blind, placebo controlled design. We are administering oral MDMA to healthy volunteers to measure its effects on the encoding, consolidation, and retrieval stages of memory.

Drug: Placebo
Experimental: MDMA at Memory Retrieval
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..
Drug: MDMA
This is a between subjects, double-blind, placebo controlled design. We are administering oral MDMA to healthy volunteers to measure its effects on the encoding, consolidation, and retrieval stages of memory.

Drug: Placebo
Placebo Comparator: Placebo at both sessions
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.
Drug: Placebo



Primary Outcome Measures :
  1. Probability of Accurately Recalling Visual Stimuli [ Time Frame: 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.


Secondary Outcome Measures :
  1. Probability of Accurately Recognizing Visual Stimuli [ Time Frame: 90 minutes into Session 2 ]
    After the cued recollection task, all of the pictures were presented to participants (i.e., the ones that they had seen, as well as the ones that were not seen). Participants were then asked, "Did you see this picture?" Hit and false alarm rates were calculated, and memory accuracy was measured as hits minus false alarms.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. any current medical condition requiring medication or abnormal electrocardiogram
  2. current or past medical condition considered to be a contraindication for the study conditions
  3. 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
  4. less than high school education
  5. lack of fluency in English
  6. night shift work
  7. pregnancy, lactation, or plans to become pregnant
  8. use of hormonal contraception

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03050541


Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Harriet de Wit, PhD University of Chicago
Principal Investigator: David Gallo, PhD University of Chicago

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT03050541     History of Changes
Other Study ID Numbers: 14-1485
First Posted: February 13, 2017    Key Record Dates
Results First Posted: June 29, 2018
Last Update Posted: June 29, 2018
Last Verified: May 2018

Keywords provided by University of Chicago:
MDMA
adult

Additional relevant MeSH terms:
N-Methyl-3,4-methylenedioxyamphetamine
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Adrenergic Agents