Effects of MDMA on Emotional and Social Memories

NCT03050541 | Completed Results

• 1 other identifier: 14-1485
• Study Type: interventional
• Target: 84
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy

Keywords

MDMA; adult

Outcome Measures

Primary Outcomes (1)

• 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.

  90 minutes into Session 2

Secondary Outcomes (1)

• Probability of Accurately Recognizing Visual Stimuli

  90 minutes into Session 2

Study Arms (3)

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.

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..

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.

Drug: Placebo

Interventions

MDMA DRUG

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.

MDMA at Memory Encoding; MDMA at Memory Retrieval

Placebo DRUG

MDMA at Memory Encoding; MDMA at Memory Retrieval; Placebo at both sessions

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chicago: lead

MeSH Terms

Interventions

N-Methyl-3,4-methylenedioxyamphetamine

Intervention Hierarchy (Ancestors)

Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Results Point of Contact

• Title: Office of Clinical Research
• Organization: University of Chicago

tkyeo@bsd.uchicago.edu

(773) 834-1238

Study Officials

• Harriet de Wit, PhD

  University of Chicago

  PRINCIPAL INVESTIGATOR

• David Gallo, PhD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2014
• First Posted: February 13, 2017
• Study Start: December 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: June 29, 2018
• Results First Posted: June 29, 2018

Record last verified: 2018-05