Evaluation of MDMA on Startle Response

February 28, 2025 updated by: Lykos Therapeutics

Evaluation of 3,4-methylenedioxymethamphetamine (MDMA) on Startle Response

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a randomized, blinded, placebo-controlled Phase 1 study that aims to evaluate the impact of 3,4-methylenedioxymethamphetamine (MDMA) on startle response.

This study will enroll healthy participants. At Visit 1, all participants will undergo a 1-hour startle test. Acoustic startle will be measured through assessing eye-blink response from the orbicularis oculi muscles in response to a 106 dB noise, using sensors under the eye. While watching the computer monitor, the participant will also experience several brief blasts of air directed at the throat.

At Visit 2 (24 hours later), participants will be randomized to receive 100 mg of MDMA or inactive placebo, after which they will undergo another startle test. Participants enrolled in the study who agree to do this will have their blood drawn to measure levels of oxytocin, and possibly other hormones or proteins, such as cortisol or brain-derived neurotrophic factor (BDNF). Measuring oxytocin will be blind to condition, and the decision will happen before randomization to either condition. Blood will be drawn before MDMA or placebo administration, and eight times afterwards.The researchers will measure pulse, blood pressure and temperature once before and six times after receiving MDMA or placebo, and study participants will complete a questionnaire about their experience.

At Visit 3, participants will return for a final startle test and recall task. Sleep will be measured via self-report and Fitbit during study participation.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
34

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Emory University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 100 mg MDMA HCl
Participants receive 100 mg MDMA HCl on their second visit
Behavioral: Acoustic startle
Startle assessment
Other Names:
  • startle test
Drug: Midomafetamine
Participants will receive 100 mg midomafetamine HCl on their second visit
Other Names:
  • MDMA
  • 3,4-methylenedioxymethamphetamine
  • midomafetamine HCl
Placebo Comparator: Placebo
Participants receive inactive placebo on their second visit
Behavioral: Acoustic startle
Startle assessment
Other Names:
  • startle test
Drug: Placebo
Participants will receive inactive placebo on their second visit.
Other Names:
  • lactose
  • inactive placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
EMG of right orbicularis oculi muscle
Time Frame: Four days post-enrollment
Description: Measure of startle response to noise after fear extinction training
Four days post-enrollment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Systolic blood pressure pre-drug
Time Frame: 5 minutes pre-drug
Systolic blood pressure measured prior to administration of MDMA or placebo
5 minutes pre-drug
Systolic blood pressure 45 min post-drug
Time Frame: 45 minutes post-drug
Systolic blood pressure measured 45 minutes after MDMA or placebo administration
45 minutes post-drug
Systolic blood pressure 1 h 15 min post-drug
Time Frame: 1 hour 15 minutes post drug
Systolic blood pressure measured 1 hour 15 minutes after MDMA or placebo administration
1 hour 15 minutes post drug
Systolic blood pressure 1 h 45 min post-drug
Time Frame: 1 hour 45 minutes post drug
Systolic blood pressure measured 1 hour 45 minutes after MDMA or placebo administration
1 hour 45 minutes post drug
Systolic blood pressure 3 h post-drug
Time Frame: 3 hours post-drug
Systolic blood pressure measured 3 hours after MDMA or placebo administration
3 hours post-drug
Systolic blood pressure 4 h post-drug
Time Frame: 4 hours post-drug
Systolic blood pressure measured 4 hours after MDMA or placebo administration
4 hours post-drug
Systolic blood pressure 5 h post-drug
Time Frame: 5 hours post-drug
Systolic blood pressure measured 5 hours after MDMA or placebo administration
5 hours post-drug
Systolic blood pressure 6 h post-drug
Time Frame: 6 hours post-drug
Systolic blood pressure measured 6 hours after MDMA or placebo administration
6 hours post-drug
Diastolic blood pressure pre-drug
Time Frame: 5 minutes pre-drug
Diastolic blood pressure measured prior to MDMA or placebo administration
5 minutes pre-drug
Diastolic blood pressure 45 min post-drug
Time Frame: 45 minutes post-drug
Diastolic blood pressure measured 45 minutes after MDMA or placebo administration
45 minutes post-drug
Diastolic blood pressure 1 h 15 min post-drug
Time Frame: 1 hour 15 minutes post-drug
Diastolic blood pressure measured 1 h 15 minutes after MDMA or placebo administration
1 hour 15 minutes post-drug
Diastolic blood pressure 1 h 45 min post-drug
Time Frame: 1 hour 45 minutes post drug
Diastolic blood pressure measured 1 h 45 minutes after MDMA or placebo administration
1 hour 45 minutes post drug
Diastolic blood pressure 3 h post-drug
Time Frame: 3 hours post-drug
Diastolic blood pressure measured 3 hours after MDMA or placebo administration
3 hours post-drug
Diastolic blood pressure 4 hours post-drug
Time Frame: 4 hours post-drug
Diastolic blood pressure measured 4 hours after MDMA or placebo administration
4 hours post-drug
Diastolic blood pressure 5 hours post-drug
Time Frame: 5 hours post-drug
Diastolic blood pressure measured 5 hours after MDMA or placebo administration
5 hours post-drug
Diastolic blood pressure 6 hours post-drug
Time Frame: 6 hours post-drug
Diastolic blood pressure measured 6 hours after MDMA or placebo administration
6 hours post-drug
Pulse pre-drug
Time Frame: 5 minutes pre-drug
Pulse (assessing heart rate) measured prior to MDMA or placebo administration
5 minutes pre-drug
Pulse 45 min post-drug
Time Frame: 45 minutes post-drug
Pulse (assessing heart rate) measured 45 min after MDMA or placebo administration
45 minutes post-drug
Pulse 1 h 15 min post-drug
Time Frame: 1 hour 15 minutes post-drug
Pulse (assessing heart rate) measured 1 hour 15 min after MDMA or placebo administration
1 hour 15 minutes post-drug
Pulse 1 h 45 min post-drug
Time Frame: 1 hour 45 minutes post-drug
Pulse (assessing heart rate) measured 1 hour 45 min after MDMA or placebo administration
1 hour 45 minutes post-drug
Pulse 3 h post-drug
Time Frame: 3 hours post-drug
Pulse (assessing heart rate) measured 3 hours after MDMA or placebo administration
3 hours post-drug
Pulse 4 h post-drug
Time Frame: 4 hours post-drug
Pulse (assessing heart rate) measured 4 hours after MDMA or placebo administration
4 hours post-drug
Pulse 5 h post-drug
Time Frame: 5 hours post-drug
Pulse (assessing heart rate) measured 5 hours after MDMA or placebo administration
5 hours post-drug
Pulse 6 h post-drug
Time Frame: 6 hours post-drug
Pulse (assessing heart rate) measured 6 hours after MDMA or placebo administration
6 hours post-drug
Body temperature pre-drug
Time Frame: 5 minutes pre-drug
Body temperature measured before MDMA or placebo administration
5 minutes pre-drug
Body temperature 45 minutes post-drug
Time Frame: 45 minutes post-drug
Body temperature measured 45 minutes after MDMA or placebo administration
45 minutes post-drug
Body temperature 1 h 15 minutes post-drug
Time Frame: 1 hour 15 minutes post-drug
Body temperature measured 1 hour 15 minutes after MDMA or placebo administration
1 hour 15 minutes post-drug
Body temperature 1 h 45 minutes post-drug
Time Frame: 1 hour 45 minutes post-drug
Body temperature measured 1 hour 45 minutes after MDMA or placebo administration
1 hour 45 minutes post-drug
Body temperature 3 hours post-drug
Time Frame: 3 hours post-drug
Body temperature measured 3 hours after MDMA or placebo administration
3 hours post-drug
Body temperature 4 hours post-drug
Time Frame: 4 hours post-drug
Body temperature measured 4 hours after MDMA or placebo administration
4 hours post-drug
Body temperature 5 hours post-drug
Time Frame: 5 hours post-drug
Body temperature measured 5 hours after MDMA or placebo administration
5 hours post-drug
Body temperature 6 hours post-drug
Time Frame: 6 hours post-drug
Body temperature measured 6 hours after MDMA or placebo administration
6 hours post-drug
Plasma oxytocin (OT) levels predrug
Time Frame: 5 min prior to drug administration
In people who agree to it, blood collected to assess levels of oxytocin prior to MDMA or placebo administration on day of drug administration
5 min prior to drug administration
Plasma oxytocin (OT) levels 5 min post-drug
Time Frame: 5 min post-drug administration
In people who agree to it, blood collected to assess levels of oxytocin approximately 5 minutes after MDMA or placebo administration
5 min post-drug administration
Plasma oxytocin (OT) levels 20 min post-drug
Time Frame: 20 min post-drug administration
In people who agree to it, blood collected to assess levels of oxytocin approximately 20 minutes after MDMA or placebo administration
20 min post-drug administration
Plasma oxytocin (OT) levels 95 min post-drug
Time Frame: 95 min post-drug administration
In people who agree to it, blood collected to assess levels of oxytocin approximately 95 minutes (approximately 1.5 h) after MDMA or placebo administration
95 min post-drug administration
Plasma oxytocin (OT) levels 110 min post-drug
Time Frame: 110 min post-drug administration
In people who agree to it, blood collected to assess levels of oxytocin approximately 110 minutes after MDMA or placebo administration
110 min post-drug administration
Plasma oxytocin (OT) levels 185 min post-drug
Time Frame: 185 min post-drug administration
In people who agree to it, blood collected to assess levels of oxytocin approximately 185 minutes after MDMA or placebo administration
185 min post-drug administration
Plasma oxytocin (OT) levels 200 min post-drug
Time Frame: 200 min post-drug administration
In people who agree to it, blood collected to assess levels of oxytocin approximately 200 minutes after MDMA or placebo administration
200 min post-drug administration
Plasma oxytocin (OT) levels 240 min post-drug
Time Frame: 240 min post-drug administration
In people who agree to it, blood collected to assess levels of oxytocin approximately 240 minutes after MDMA or placebo administration
240 min post-drug administration
Plasma oxytocin (OT) levels 300 min post-drug
Time Frame: 300 min post-drug administration
In people who agree to it, blood collected to assess levels of oxytocin approximately 300 minutes after MDMA or placebo administration
300 min post-drug administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lykos Therapeutics

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Barbara Rothbaum, Emory University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 14, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 5, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 7, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 9, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MPVA-4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We plan to share data after quality analysis and upon request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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