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Effects of MDMA on Emotional and Social Memories

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Basic Science
Condition Healthy
Interventions Drug: MDMA
Drug: Placebo
Enrollment 84
Recruitment Details  
Pre-assignment Details  
Arm/Group Title MDMA at Memory Encoding MDMA at Memory Retrievial Placebo at Both Sessions
Hide Arm/Group Description

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.

Oral 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.

Placebo

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..

Oral 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.

Placebo

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.

Placebo

Period Title: Overall Study
Started 28 28 28
Completed 20 20 20
Not Completed 8 8 8
Arm/Group Title Healthy Adult Volunteers-Oral MDMA at Memory Encoding Healthy Adult Volunteers-Oral MDMA at Memory Retrievial Healthy Adult Volunteers-Placebo at Both Sessions Total
Hide Arm/Group Description

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.

Oral 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.

Placebo

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..

Oral 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.

Placebo

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.

Placebo

Total of all reporting groups
Overall Number of Baseline Participants 20 20 20 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 20 participants 60 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
20
 100.0%
20
 100.0%
20
 100.0%
60
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 20 participants 60 participants
Female
10
  50.0%
10
  50.0%
10
  50.0%
30
  50.0%
Male
10
  50.0%
10
  50.0%
10
  50.0%
30
  50.0%
1.Primary Outcome
Title Probability of Accurately Recalling Visual Stimuli
Hide Description 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.
Time Frame 90 minutes into Session 2
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Healthy Adult Volunteers-Oral MDMA at Memory Encoding Healthy Adult Volunteers-Oral MDMA at Memory Retrievial Healthy Adult Volunteers-Placebo at Both Sessions
Hide Arm/Group Description:

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.

Oral 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.

Placebo

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..

Oral 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.

Placebo

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.

Placebo

Overall Number of Participants Analyzed 20 20 20
Mean (Standard Deviation)
Unit of Measure: probability
.52  (.11) .50  (.16) .54  (.17)
2.Secondary Outcome
Title Probability of Accurately Recognizing Visual Stimuli
Hide Description 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.
Time Frame 90 minutes into Session 2
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Healthy Adult Volunteers-Oral MDMA at Memory Encoding Healthy Adult Volunteers-Oral MDMA at Memory Retrievial Healthy Adult Volunteers-Placebo at Both Sessions
Hide Arm/Group Description:

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.

Oral 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.

Placebo

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..

Oral 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.

Placebo

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.

Placebo

Overall Number of Participants Analyzed 20 20 20
Mean (Standard Deviation)
Unit of Measure: probability
.82  (.09) .81  (.15) .84  (.11)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Healthy Adult Volunteers-Oral MDMA at Memory Encoding Healthy Adult Volunteers-Oral MDMA at Memory Retrievial Healthy Adult Volunteers-Placebo at Both Sessions
Hide Arm/Group Description

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.

Oral 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.

Placebo

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..

Oral 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.

Placebo

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.

Placebo

All-Cause Mortality
Healthy Adult Volunteers-Oral MDMA at Memory Encoding Healthy Adult Volunteers-Oral MDMA at Memory Retrievial Healthy Adult Volunteers-Placebo at Both Sessions
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
Healthy Adult Volunteers-Oral MDMA at Memory Encoding Healthy Adult Volunteers-Oral MDMA at Memory Retrievial Healthy Adult Volunteers-Placebo at Both Sessions
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%)   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Healthy Adult Volunteers-Oral MDMA at Memory Encoding Healthy Adult Volunteers-Oral MDMA at Memory Retrievial Healthy Adult Volunteers-Placebo at Both Sessions
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%)   0/0 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Office of Clinical Research
Organization: University of Chicago
Phone: (773) 834-1238
EMail: tkyeo@bsd.uchicago.edu
Layout table for additonal information
Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT03050541    
Other Study ID Numbers: 14-1485
First Submitted: December 18, 2014
First Posted: February 13, 2017
Results First Submitted: June 7, 2017
Results First Posted: June 29, 2018
Last Update Posted: June 29, 2018