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"Evaluation of MDMA on Startle Response

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ClinicalTrials.gov Identifier: NCT03181763
Recruitment Status : Recruiting
First Posted : June 9, 2017
Last Update Posted : February 9, 2018
Sponsor:
Information provided by (Responsible Party):
Multidisciplinary Association for Psychedelic Studies

Brief Summary:
This study will examine how the drug methylenedioxymethamphetamine (MDMA) impacts response to different types of memory in humans compared to placebo. MDMA is an experimental drug and is illegal to possess outside of research; when sold illegally it is referred to as Ecstasy or Molly (material supposedly containing MDMA). MDMA may make it easier to face unpleasant memories and reduce anxiety, and it may do so in part by influencing response to memories. This study will enroll healthy adults who will need to come in for three visits over four days. At visit 1, participants will undergo a 1-hour startle test. The startle test measures eye-blink response to loud sounds. After this, the participant will also view different colored shapes presented on a computer monitor. While watching the computer monitor, the participant will experience several brief blasts of air directed at the throat, while eye-blink is measured with sensors under the eye. The following day at visit 2, participants will be randomized to receive placebo or 100 mg MDMA and will complete tasks similar to the ones completed the previous day. The researchers will measure pulse, blood pressure and temperature once before and seven times after receiving MDMA or placebo, and study participants will complete a questionnaire about their experience. Two days after receiving MDMA or placebo, participants will return for a third visit to complete similar tasks to previous visits. This study will also measure sleep through a sleep diary and actigraphy, which is a device worn on the wrist like a watch that records movement during sleep and lets researchers see how much sleep a person is getting.

Condition or disease Intervention/treatment Phase
Startle Response Drug: Placebo Drug: MDMA Behavioral: Acoustic startle Phase 1

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 . MDMA is an experimental drug and is illegal to possess outside of research; when sold illegally it is referred to as Ecstasy or Molly (material supposedly containing MDMA). MDMA may make it easier to face unpleasant memories and reduce anxiety.

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 task. 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 Fittbit during study participation.

The primary objective of this study is to assess whether MDMA affects startle response


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Blinded, placebo between group; all participants undergo fear conditioning, with half randomized to receive 100 mg MDMA and half receiving inactive placebo
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Evaluation of 3,4-methylenedioxymethamphetamine (MDMA) on Startle Response
Actual Study Start Date : September 21, 2017
Estimated Primary Completion Date : August 10, 2018
Estimated Study Completion Date : September 10, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Club Drugs
U.S. FDA Resources

Arm Intervention/treatment
Experimental: MDMA
Participants receive 100 mg MDMA
Drug: MDMA
Participant will receive 100 mg MDMA one day after startle assessment
Other Name: 3,4-methylenedioxymethamphetamine
Behavioral: Acoustic startle
Startle assessment
Placebo Comparator: Placebo
Participants receive inactive placebo
Drug: Placebo
Placebo given day after startle assessment
Behavioral: Acoustic startle
Startle assessment



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Persons aged 21 to 50.
  • 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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03181763


Contacts
Contact: Callan M Coghlan 404-778-0882 callan.m.coghlan@emory.edu

Locations
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30329
Contact: Callan Coghlan       callan.m.coghlan@emory.edu   
Principal Investigator: Barbara Rothbaum, PhD         
Sponsors and Collaborators
Multidisciplinary Association for Psychedelic Studies
Investigators
Principal Investigator: Barbara Rothbaum Emory University

Responsible Party: Multidisciplinary Association for Psychedelic Studies
ClinicalTrials.gov Identifier: NCT03181763     History of Changes
Other Study ID Numbers: MPVA-4
First Posted: June 9, 2017    Key Record Dates
Last Update Posted: February 9, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We plan to share data after quality analysis and upon request.

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Multidisciplinary Association for Psychedelic Studies:
MDMA
Startle response
sleep

Additional relevant MeSH terms:
N-Methyl-3,4-methylenedioxyamphetamine
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Adrenergic Agents