Effects of MDMA on Emotional and Social Memories

NCT ID: NCT03050541

Last Updated: 2018-06-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2016-09-30

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.

Conditions

Healthy

Keywords

MDMA; adult

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

MDMA

Intervention Type: 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.

Placebo

Intervention Type: DRUG

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..

Group Type: EXPERIMENTAL

MDMA

Intervention Type: 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.

Placebo

Intervention Type: DRUG

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

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.

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Harriet de Wit, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

David Gallo, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Other Identifiers

14-1485

Identifier Type: -

Identifier Source: org_study_id