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Completed

NCT Number: NCT03181763

Evaluation of 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.

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Key information

Conditions

Startle Response

Age range

21 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Emory University

Atlanta, Georgia, 30329, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo

Drug

Participants will receive inactive placebo on their second visit.

Other names: inactive placebo, lactose

Midomafetamine

Drug

Participants will receive 100 mg midomafetamine HCl on their second visit

Other names: 3,4-methylenedioxymethamphetamine, MDMA, midomafetamine HCl

Acoustic startle

Behavioral

Startle assessment

Other names: startle test

Primary outcomes

  1. EMG of right orbicularis oculi muscle

    Time frame: Four days post-enrollment

    Description: Measure of startle response to noise after fear extinction training

Secondary outcomes

  1. Systolic blood pressure pre-drug

    Time frame: 5 minutes pre-drug

    Systolic blood pressure measured prior to administration of MDMA or placebo

  2. Systolic blood pressure 45 min post-drug

    Time frame: 45 minutes post-drug

    Systolic blood pressure measured 45 minutes after MDMA or placebo administration

  3. 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

  4. 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

  5. Systolic blood pressure 3 h post-drug

    Time frame: 3 hours post-drug

    Systolic blood pressure measured 3 hours after MDMA or placebo administration

  6. Systolic blood pressure 4 h post-drug

    Time frame: 4 hours post-drug

    Systolic blood pressure measured 4 hours after MDMA or placebo administration

  7. Systolic blood pressure 5 h post-drug

    Time frame: 5 hours post-drug

    Systolic blood pressure measured 5 hours after MDMA or placebo administration

  8. Systolic blood pressure 6 h post-drug

    Time frame: 6 hours post-drug

    Systolic blood pressure measured 6 hours after MDMA or placebo administration

  9. Diastolic blood pressure pre-drug

    Time frame: 5 minutes pre-drug

    Diastolic blood pressure measured prior to MDMA or placebo administration

  10. Diastolic blood pressure 45 min post-drug

    Time frame: 45 minutes post-drug

    Diastolic blood pressure measured 45 minutes after MDMA or placebo administration

  11. 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

  12. 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

  13. Diastolic blood pressure 3 h post-drug

    Time frame: 3 hours post-drug

    Diastolic blood pressure measured 3 hours after MDMA or placebo administration

  14. Diastolic blood pressure 4 hours post-drug

    Time frame: 4 hours post-drug

    Diastolic blood pressure measured 4 hours after MDMA or placebo administration

  15. Diastolic blood pressure 5 hours post-drug

    Time frame: 5 hours post-drug

    Diastolic blood pressure measured 5 hours after MDMA or placebo administration

  16. Diastolic blood pressure 6 hours post-drug

    Time frame: 6 hours post-drug

    Diastolic blood pressure measured 6 hours after MDMA or placebo administration

  17. Pulse pre-drug

    Time frame: 5 minutes pre-drug

    Pulse (assessing heart rate) measured prior to MDMA or placebo administration

  18. Pulse 45 min post-drug

    Time frame: 45 minutes post-drug

    Pulse (assessing heart rate) measured 45 min after MDMA or placebo administration

  19. 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

  20. 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

  21. Pulse 3 h post-drug

    Time frame: 3 hours post-drug

    Pulse (assessing heart rate) measured 3 hours after MDMA or placebo administration

  22. Pulse 4 h post-drug

    Time frame: 4 hours post-drug

    Pulse (assessing heart rate) measured 4 hours after MDMA or placebo administration

  23. Pulse 5 h post-drug

    Time frame: 5 hours post-drug

    Pulse (assessing heart rate) measured 5 hours after MDMA or placebo administration

  24. Pulse 6 h post-drug

    Time frame: 6 hours post-drug

    Pulse (assessing heart rate) measured 6 hours after MDMA or placebo administration

  25. Body temperature pre-drug

    Time frame: 5 minutes pre-drug

    Body temperature measured before MDMA or placebo administration

  26. Body temperature 45 minutes post-drug

    Time frame: 45 minutes post-drug

    Body temperature measured 45 minutes after MDMA or placebo administration

  27. 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

  28. 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

  29. Body temperature 3 hours post-drug

    Time frame: 3 hours post-drug

    Body temperature measured 3 hours after MDMA or placebo administration

  30. Body temperature 4 hours post-drug

    Time frame: 4 hours post-drug

    Body temperature measured 4 hours after MDMA or placebo administration

  31. Body temperature 5 hours post-drug

    Time frame: 5 hours post-drug

    Body temperature measured 5 hours after MDMA or placebo administration

  32. Body temperature 6 hours post-drug

    Time frame: 6 hours post-drug

    Body temperature measured 6 hours after MDMA or placebo administration

  33. 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

  34. 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

  35. 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

  36. 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

  37. 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

  38. 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

  39. 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

  40. 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

  41. 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

Sponsors and collaborators

Lead sponsor

Resilient Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jun 9, 2017
Registry last updated
Mar 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.