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CompletedPhase 1

Evaluation of MDMA on Startle Response

NCT03181763 · Resilient Pharmaceuticals

Closed to entry
Status
Not accepting participants
Phase 1
Phase
34
Target enrolment
1
Study sites
1 US states

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • EMG of right orbicularis oculi muscle

    Measured over Four days post-enrollment

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

21 Years to 55 Years
Ages
All
Sex
Accepted
Healthy volunteers
Inclusion Criteria: * Persons aged 21 to 55. * Ability to visually read and understand English language. * Live within in metro Atlanta area * Previously used MDMA in a recreational or research setting * If a person is of childbearing potential (able to bear children), they must have a negative pregnancy test at study entry and prior to the Experimental Session. They must agree to use adequate birth control through 10 days after the last dose of MDMA. Adequate birth control methods include intrauterine device (IUD), injected or implanted hormonal methods, abstinence, oral hormones plus a barrier contraception or double barrier contraception. Two forms of contraception are required with any barrier method or oral hormones (i.e. condom plus diaphragm, condom or diaphragm plus spermicide, oral hormonal contraceptives plus spermicide or condom). Not of childbearing potential is defined as permanent sterilization, postmenopausal, or male. * (For sub-study measuring serum oxytocin) Willing to have periodic blood draws Exclusion Criteria: * Upon review of medical or psychiatric history, have any current or past diagnosis that would be considered a risk to participating in the study. * Are abusing illegal drugs. * Current use of any psychoactive medications, including antidepressants, mood stabilizers, sedatives, stimulants, antipsychotics, anxiolytics, or beta-blockers * Are not able to give adequate informed consent. * Uncontrolled hypertension, or clinically significant cardiac arrhythmia, as detected by electrocardiogram. * Currently pregnant or breast-feeding. * History of acute angle glaucoma. * Hearing impairment as assessed by audiometer; unable to detect tones below 40 dB in right or left ear.

Where

1 study site

FacilityCityRegionCountry
Emory UniversityAtlantaGeorgiaUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT03181763 on ClinicalTrials.gov →

Last updated in the registry 2025-03-04. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits