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Evaluation of MDMA on Startle Response

NCT03181763 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2025-03-04

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if MDMA impacts startle response in healthy participants.

The main question it aims to answer is: Does MDMA impact participant's performance on a startle test?

Researchers will compare healthy volunteers who have taken MDMA to those who have taken placebo.

Participants will first undergo a 1-hour startle test. The next day, they will be randomized to receive either MDMA or placebo followed by another startle test and vitals signs and blood measurements. Participants will return the next day for a final startle test. Their sleep will be tracked by a Fitbit device.

Conditions

  • Startle Response

Interventions

DRUG

Placebo

Participants will receive inactive placebo on their second visit.

DRUG

Midomafetamine

Participants will receive 100 mg midomafetamine HCl on their second visit

BEHAVIORAL

Acoustic startle

Startle assessment

Sponsors & Collaborators

Principal Investigators

  • Barbara Rothbaum · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-03-14
Primary Completion
2020-08-01
Completion
2020-08-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03181763 on ClinicalTrials.gov