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Evaluation of MDMA on Startle Response

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03181763
Recruitment Status : Completed
First Posted : June 9, 2017
Last Update Posted : February 23, 2021
Sponsor:
Information provided by (Responsible Party):
Multidisciplinary Association for Psychedelic Studies

Tracking Information
First Submitted Date  ICMJE June 5, 2017
First Posted Date  ICMJE June 9, 2017
Last Update Posted Date February 23, 2021
Actual Study Start Date  ICMJE September 21, 2017
Actual Primary Completion Date August 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 7, 2017)
EMG of right orbicularis oculi muscle [ Time Frame: Four days post-enrollment ]
Description: Measure of startle response to noise after fear extinction training
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 1, 2019)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: June 7, 2017)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of MDMA on Startle Response
Official Title  ICMJE Evaluation of 3,4-methylenedioxymethamphetamine (MDMA) on Startle Response
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. Participants who agree to do so will have blood drawn to measure the neurohormones oxytocin and cortisol and brain-derived neurotrophic factor (BDNF) before and after drug administration on Visit 2. 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.
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. 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 Fittbit during study participation.

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

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE 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
Condition  ICMJE Startle Response
Intervention  ICMJE
  • Drug: Placebo
    Placebo given day after startle assessment
  • Drug: MDMA
    Participant will receive 100 mg MDMA one day after startle assessment
    Other Name: 3,4-methylenedioxymethamphetamine
  • Behavioral: Acoustic startle
    Startle assessment
Study Arms  ICMJE
  • Experimental: MDMA
    Participants receive 100 mg MDMA
    Interventions:
    • Drug: MDMA
    • Behavioral: Acoustic startle
  • Placebo Comparator: Placebo
    Participants receive inactive placebo
    Interventions:
    • Drug: Placebo
    • Behavioral: Acoustic startle
Publications * Maples-Keller JL, Norrholm SD, Burton M, Reiff C, Coghlan C, Jovanovic T, Yasinski C, Jarboe K, Rakofsky J, Rauch S, Dunlop BW, Rothbaum BO. A randomized controlled trial of 3,4-methylenedioxymethamphetamine (MDMA) and fear extinction retention in healthy adults. J Psychopharmacol. 2022 Mar;36(3):368-377. doi: 10.1177/02698811211069124. Epub 2022 Feb 15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 28, 2020)
34
Original Estimated Enrollment  ICMJE
 (submitted: June 7, 2017)
30
Actual Study Completion Date  ICMJE November 4, 2020
Actual Primary Completion Date August 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03181763
Other Study ID Numbers  ICMJE MPVA-4
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: We plan to share data after quality analysis and upon request.
Responsible Party Multidisciplinary Association for Psychedelic Studies
Study Sponsor  ICMJE Multidisciplinary Association for Psychedelic Studies
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Barbara Rothbaum Emory University
PRS Account Multidisciplinary Association for Psychedelic Studies
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP