HealthyNCT03050541

Effects of MDMA on Emotional and Social Memories

A study testing MDMA in people with Healthy, run by University of Chicago.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: MDMA
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 84 participants
Where: No sites listed yet
Study dates: Dec 2014to Sep 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 40 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

About this study

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

Read the 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.

Conditions: Healthy
Being tested: MDMA, Placebo
Keywords: MDMA, adult

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MDMADrug
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.
PlaceboDrug

Study groups in NCT03050541
Study group	Role	What they receive
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. Receives: Drug: MDMA; Drug: Placebo
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.. Receives: Drug: MDMA; Drug: Placebo
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. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Probability of Accurately Recalling Visual Stimuli
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.
Measured: 90 minutes into Session 2

Secondary outcomes (1)

Probability of Accurately Recognizing Visual Stimuli
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.
Measured: 90 minutes into Session 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2014Sep 2016

First posted13 Feb 2017
Study startDec 2014
Primary completionSep 2016
Study completionSep 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by University of ChicagoThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 84 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03050541
Sponsor's protocol ID: 14-1485
Status last verified: May 2018
First submitted: 18 Dec 2014
Last updated: 29 Jun 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 29 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effects of 3,4-methylenedioxy-N-methylamphetamine (MDMA) on Encoding, Consolidation, and Retrieval of Emotional and Social Memories
ClinicalTrials.gov ID: NCT03050541
Acronym / sponsor ID: 14-1485
Conditions: Healthy
Keywords: MDMA, adult
Study type: Interventional
Recruitment status: Completed
Enrolment: 84 participants (actual)
Lead sponsor: University of ChicagoUniversity, hospital or other
Study start: Dec 2014
Primary completion: Sep 2016 (actual)
Study completion: Sep 2016 (actual)
First posted: 13 Feb 2017 (actual)
Results: Posted 29 Jun 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
MDMA at Memory Encoding	Experimental	Drug: MDMA, Drug: Placebo20 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.
MDMA at Memory Retrieval	Experimental	Drug: MDMA, Drug: Placebo20 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..
Placebo at both sessions	Placebo comparator	Drug: Placebo20 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.

Who may qualify

Ages: 18 to 40 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MDMAThis 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	MDMA at Memory Encoding, MDMA at Memory Retrieval
Placebo	Drug	MDMA at Memory Encoding, MDMA at Memory Retrieval, Placebo at both sessions

Primary outcome

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.

1 secondary outcome

Probability of Accurately Recognizing Visual Stimuli
Time frame: 90 minutes into Session 2

Results and safety

Results posted to the registry on 29 Jun 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MDMA at Memory Encoding	28	20
MDMA at Memory Retrievial	28	20
Placebo at Both Sessions	28	20

Primary outcome: Probability of Accurately Recalling Visual Stimuli

Time frame: 90 minutes into Session 2. Mean (Standard Deviation). Unit: probability

Measure	Healthy Adult Volunteers-Oral MDMA at Memory Encoding n = 20	Healthy Adult Volunteers-Oral MDMA at Memory Retrievial n = 20	Healthy Adult Volunteers-Placebo at Both Sessions n = 20
Value	.52 (.11)	.50 (.16)	.54 (.17)

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Healthy Adult Volunteers-Oral MDMA at Memory Encoding	0 of 20 (0%)	0 of 20 (0%)	Not reported
Healthy Adult Volunteers-Oral MDMA at Memory Retrievial	0 of 20 (0%)	0 of 20 (0%)	Not reported
Healthy Adult Volunteers-Placebo at Both Sessions	0 of 0	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Harriet de Wit, PhD principal investigator

University of Chicago

David Gallo, PhD principal investigator

University of Chicago

Questions about this trial

What is this clinical trial studying?

A study testing MDMA in people with Healthy, run by University of Chicago.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Probability of Accurately Recalling Visual Stimuli (time frame: 90 minutes into Session 2). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03050541.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2018; AzTrials last refreshed its copy on 8 Nov 2026.