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"Evaluation of MDMA on Startle Response

This study is currently recruiting participants.
Verified October 2017 by Multidisciplinary Association for Psychedelic Studies
Sponsor:
ClinicalTrials.gov Identifier:
NCT03181763
First Posted: June 9, 2017
Last Update Posted: November 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Multidisciplinary Association for Psychedelic Studies
  Purpose
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 Intervention Phase
Startle Response Drug: Placebo Drug: MDMA Behavioral: Acoustic startle Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Multidisciplinary Association for Psychedelic Studies:

Primary Outcome Measures:
  • 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:
  • Systolic blood pressure pre-drug [ Time Frame: 5 minutes pre-drug ]
    Systolic blood pressure measured prior to administration of MDMA or placebo

  • Systolic blood pressure 45 min post-drug [ Time Frame: 45 minutes post-drug ]
    Systolic blood pressure measured 45 minutes after MDMA or placebo administration

  • 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

  • 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

  • Systolic blood pressure 3 h post-drug [ Time Frame: 3 hours post-drug ]
    Systolic blood pressure measured 3 hours after MDMA or placebo administration

  • Systolic blood pressure 4 h post-drug [ Time Frame: 4 hours post-drug ]
    Systolic blood pressure measured 4 hours after MDMA or placebo administration

  • Systolic blood pressure 5 h post-drug [ Time Frame: 5 hours post-drug ]
    Systolic blood pressure measured 5 hours after MDMA or placebo administration

  • Systolic blood pressure 6 h post-drug [ Time Frame: 6 hours post-drug ]
    Systolic blood pressure measured 6 hours after MDMA or placebo administration

  • Diastolic blood pressure pre-drug [ Time Frame: 5 minutes pre-drug ]
    Diastolic blood pressure measured prior to MDMA or placebo administration

  • Diastolic blood pressure 45 min post-drug [ Time Frame: 45 minutes post-drug ]
    Diastolic blood pressure measured 45 minutes after MDMA or placebo administration

  • 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

  • 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

  • Diastolic blood pressure 3 h post-drug [ Time Frame: 3 hours post-drug ]
    Diastolic blood pressure measured 3 hours after MDMA or placebo administration

  • Diastolic blood pressure 4 hours post-drug [ Time Frame: 4 hours post-drug ]
    Diastolic blood pressure measured 4 hours after MDMA or placebo administration

  • Diastolic blood pressure 5 hours post-drug [ Time Frame: 5 hours post-drug ]
    Diastolic blood pressure measured 5 hours after MDMA or placebo administration

  • Diastolic blood pressure 6 hours post-drug [ Time Frame: 6 hours post-drug ]
    Diastolic blood pressure measured 6 hours after MDMA or placebo administration

  • Pulse pre-drug [ Time Frame: 5 minutes pre-drug ]
    Pulse (assessing heart rate) measured prior to MDMA or placebo administration

  • Pulse 45 min post-drug [ Time Frame: 45 minutes post-drug ]
    Pulse (assessing heart rate) measured 45 min after MDMA or placebo administration

  • 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

  • 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

  • Pulse 3 h post-drug [ Time Frame: 3 hours post-drug ]
    Pulse (assessing heart rate) measured 3 hours after MDMA or placebo administration

  • Pulse 4 h post-drug [ Time Frame: 4 hours post-drug ]
    Pulse (assessing heart rate) measured 4 hours after MDMA or placebo administration

  • Pulse 5 h post-drug [ Time Frame: 5 hours post-drug ]
    Pulse (assessing heart rate) measured 5 hours after MDMA or placebo administration

  • Pulse 6 h post-drug [ Time Frame: 6 hours post-drug ]
    Pulse (assessing heart rate) measured 6 hours after MDMA or placebo administration

  • Body temperature pre-drug [ Time Frame: 5 minutes pre-drug ]
    Body temperature measured before MDMA or placebo administration

  • Body temperature 45 minutes post-drug [ Time Frame: 45 minutes post-drug ]
    Body temperature measured 45 minutes after MDMA or placebo administration

  • 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

  • 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

  • Body temperature 3 hours post-drug [ Time Frame: 3 hours post-drug ]
    Body temperature measured 3 hours after MDMA or placebo administration

  • Body temperature 4 hours post-drug [ Time Frame: 4 hours post-drug ]
    Body temperature measured 4 hours after MDMA or placebo administration

  • Body temperature 5 hours post-drug [ Time Frame: 5 hours post-drug ]
    Body temperature measured 5 hours after MDMA or placebo administration

  • Body temperature 6 hours post-drug [ Time Frame: 6 hours post-drug ]
    Body temperature measured 6 hours after MDMA or placebo administration


Estimated Enrollment: 30
Actual Study Start Date: September 21, 2017
Estimated Study Completion Date: September 10, 2018
Estimated Primary Completion Date: August 10, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

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.
  • 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.
  • 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.
  Contacts and Locations
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.cohlan@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
  More Information

Responsible Party: Multidisciplinary Association for Psychedelic Studies
ClinicalTrials.gov Identifier: NCT03181763     History of Changes
Other Study ID Numbers: MPVA-4
First Submitted: June 5, 2017
First Posted: June 9, 2017
Last Update Posted: November 1, 2017
Last Verified: October 2017
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