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History of Changes for Study: NCT03181763
"Evaluation of MDMA on Extinction of Fear Learning
Latest version (submitted February 22, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 June 7, 2017 None (earliest Version on record)
2 June 13, 2017 Contacts/Locations and Study Status
3 August 28, 2017 Arms and Interventions, Conditions, Study Description, Study Status and Study Identification
4 September 21, 2017 Recruitment Status, Contacts/Locations, Study Status and Study Description
5 October 16, 2017 Contacts/Locations, Study Status and Study Identification
6 October 30, 2017 Contacts/Locations and Study Status
7 January 10, 2018 Contacts/Locations and Study Status
8 February 7, 2018 Study Status and Eligibility
9 May 23, 2018 Study Status and Contacts/Locations
10 September 12, 2018 Study Status
11 December 10, 2018 Study Status
12 January 10, 2019 Study Status and Eligibility
13 May 1, 2019 Study Status, Study Description, Eligibility, Outcome Measures and Conditions
14 June 12, 2019 Contacts/Locations and Study Status
15 August 12, 2019 Study Status
16 February 18, 2020 Study Status
17 July 31, 2020 Study Status and Study Identification
18 September 16, 2020 Study Status
19 September 25, 2020 Study Status
20 October 28, 2020 Recruitment Status, Study Status, Contacts/Locations and Study Design
21 February 22, 2021 Recruitment Status and Study Status
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Study NCT03181763
Submitted Date:  June 7, 2017 (v1)

Open or close this module Study Identification
Unique Protocol ID: MPVA-4
Brief Title: "Evaluation of MDMA on Extinction of Fear Learning
Official Title: Evaluation of 3,4-methylenedioxymethamphetamine (MDMA) on Extinction of Fear Learning
Secondary IDs:
Open or close this module Study Status
Record Verification: May 2017
Overall Status: Not yet recruiting
Study Start: August 10, 2017
Primary Completion: August 10, 2018 [Anticipated]
Study Completion: September 10, 2018 [Anticipated]
First Submitted: June 5, 2017
First Submitted that
Met QC Criteria:
June 7, 2017
First Posted: June 9, 2017 [Actual]
Last Update Submitted that
Met QC Criteria:
June 7, 2017
Last Update Posted: June 9, 2017 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Multidisciplinary Association for Psychedelic Studies
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
Brief Summary: This study will examine how the drug methylenedioxymethamphetamine (MDMA) impacts the process of reducing fear 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 making it easier to "unlearn" fear. This study will enroll healthy adults. At visit 1, participants will undergo a 1-hour fear learning with 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. 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, 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 the process of reducing fear in humans. 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 making it easier to "unlearn" fear.

This study will enroll healthy participants. At visit 1 all participants will undergo a 1-hour startle test and fear learning session. Acoustic startle will be measured through assessing eye-blink response from the orbicularis oculi muscles in response to a 100 dB noise. For fear conditioning, the participant will see different colored shapes presented on a computer monitor. 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 a startle task and fear extinction task. The researchers will measure pulse, blood pressure and temperature once before and six times after receiving MDMA, and study participants will complete a questionnaire about their experience. At visit 3, participants will return for a final startle test and fear recall task. Sleep will be measured via self-report and actigraphy during study participation.

The primary objective of this study is to assess whether individuals who receive MDMA will "unlearn" fear better than participants who receive placebo. Startle response will be measured by the eye blink component of the acoustic startle response measured via electromyography (EMG) of the right orbicularis oculi muscle (under the right eye).

Open or close this module Conditions
Conditions: Fear Extinction
Keywords: MDMA
fear extinction
sleep
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Basic Science
Study Phase: Phase 1
Interventional Study Model: Parallel Assignment
Blinded, placebo between group; all participants undergo fear conditioning, with half randomized to receive 100 mg MDMA and half receiving inactive placebo
Number of Arms: 2
Masking: Double (Participant, Investigator)
Allocation: Randomized
Enrollment: 30 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: MDMA
Participants receive 100 mg MDMA
Drug: MDMA
Participant will receive 100 mg MDMA one day after fear conditioning
Other Names:
  • 3,4-methylenedioxymethamphetamine
Behavioral: Acoustic startle
Startle assessment performed after fear conditioning
Other Names:
  • Acoustic startle performed after fear conditioning
Placebo Comparator: Placebo
Participants receive inactive placebo
Drug: Placebo
Placebo given day after fear conditioning
Behavioral: Acoustic startle
Startle assessment performed after fear conditioning
Other Names:
  • Acoustic startle performed after fear conditioning
Open or close this module Outcome Measures
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
Open or close this module Eligibility
Minimum Age: 21 Years
Maximum Age: 50 Years
Sex: All
Gender Based:
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.
Open or close this module Contacts/Locations
Central Contact Person: Rebecca Matthews
Telephone: 510-499-1975
Email: Rebecca@mapsbcorp.com
Study Officials: Barbara Rothbaum
Principal Investigator
Emory University
Locations: United States, Georgia
Emory University
Atlanta, Georgia, United States, 30329
Contact:Contact: Barbara Rothbaum 404-712-8866 brothba@emory.edu
Open or close this module IPDSharing
Plan to Share IPD: Yes
We plan to share data after quality analysis and upon request.
Supporting Information:
Time Frame:
Access Criteria:
URL:
Open or close this module References
Links:
Available IPD/Information:

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