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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

Tracking Information
First Submitted Date  ICMJE December 18, 2014
First Posted Date  ICMJE February 13, 2017
Results First Submitted Date  ICMJE June 7, 2017
Results First Posted Date  ICMJE June 29, 2018
Last Update Posted Date June 29, 2018
Study Start Date  ICMJE December 2014
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 30, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 10, 2017)
Accuracy in participant's recollection of visual stimuli across positive, neutral and negative photographic stimuli [ Time Frame: 90 minutes into Session 2 ]
The study tasks will include the International Affective Picture System (IAPS; Lang et al, 1999). The IAPS consists of standardized positive, neutral, and negative pictures, and each image is associated with a brief label. During the viewing phase, participants will view 120 unique IAPS pictures with labels (40 negative/unpleasant, 40 neutral, and 40 positive/pleasant, based on normative ratings with emotional items matched for arousal). Intermixed with these items, they also will view 120 labels without pictures (40 negative, 40 neutral, 40 positive; the same stimuli will be coded for their social context in separate analyses). Participants will rate the perceived arousal and valence of each picture on two 7-point scales: 1) Affective valence -3 to +3 and 2) physiological reaction (0-6).Two days later, they will be given two surprise memory tests.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 30, 2018)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 10, 2017)
Accuracy in recognition of images from stimuli [ Time Frame: 90 minutes into Session 2 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of MDMA on Emotional and Social Memories
Official Title  ICMJE The Effects of 3,4-methylenedioxy-N-methylamphetamine (MDMA) on Encoding, Consolidation, and Retrieval of Emotional and Social Memories
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: MDMA
    • 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..
    Interventions:
    • Drug: MDMA
    • 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.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 30, 2018)
84
Original Actual Enrollment  ICMJE
 (submitted: February 10, 2017)
60
Actual Study Completion Date  ICMJE September 2016
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03050541
Other Study ID Numbers  ICMJE 14-1485
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Chicago
Study Sponsor  ICMJE University of Chicago
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Harriet de Wit, PhD University of Chicago
Principal Investigator: David Gallo, PhD University of Chicago
PRS Account University of Chicago
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP