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Effect of Methylenedioxymethamphetamine (MDMA) (Serotonin Release) on Fear Extinction (MFE)

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: NCT03527316
Recruitment Status : Completed
First Posted : May 17, 2018
Last Update Posted : January 19, 2022
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Tracking Information
First Submitted Date  ICMJE May 4, 2018
First Posted Date  ICMJE May 17, 2018
Last Update Posted Date January 19, 2022
Actual Study Start Date  ICMJE October 18, 2019
Actual Primary Completion Date December 10, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 4, 2018)
  • Fear extinction measured by Skin conductance response [ Time Frame: 12 months ]
    a) Skin conductance response to conditioned stimuli
  • Fear extinction measured by Fear-potentiated startle [ Time Frame: 12 months ]
    b) Fear-potentiated startle to conditioned stimuli
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 16, 2018)
  • Plasma concentration of Oxytocin [ Time Frame: 12 months ]
  • Subjective effects measured by Visual analog scales [ Time Frame: 12 months ]
    Visual analog scales, 0-100, 0 for 'not at all' and 100 for 'extremely'
  • Autonomic effects measured by Blood pressure [ Time Frame: 12 months ]
    Autonomic effects measured by vital signs
  • Autonomic effects measured by Hearth rate [ Time Frame: 12 months ]
    Autonomic effects measured by vital signs
  • Autonomic effects measured by Body temperature [ Time Frame: 12 months ]
    Autonomic effects measured by vital signs
  • Subjective effects measured by State-trait anxiety inventory for state (STAI-S) [ Time Frame: 12 months ]
  • Plasma concentration of MDMA [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 4, 2018)
  • Plasma concentration of Oxytocin [ Time Frame: 12 months ]
  • Subjective effects measured by Visual analog scales [ Time Frame: 12 months ]
    Visual analog scales (VAS)
  • Autonomic effects measured by Blood pressure [ Time Frame: 12 months ]
    Autonomic effects measured by vital signs
  • Autonomic effects measured by Hearth rate [ Time Frame: 12 months ]
    Autonomic effects measured by vital signs
  • Autonomic effects measured by Body temperature [ Time Frame: 12 months ]
    Autonomic effects measured by vital signs
  • Subjective effects measured by State-trait anxiety inventory for state (STAI-S) [ Time Frame: 12 months ]
  • Plasma concentration of MDMA [ Time Frame: 12 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Methylenedioxymethamphetamine (MDMA) (Serotonin Release) on Fear Extinction
Official Title  ICMJE Effect of MDMA (Serotonin Release) on Fear Extinction
Brief Summary Serotonin and oxytocin play a role in fear conditioning and fear extinction learning, psychological processes that are critically involved in psychiatric disorders such as posttraumatic stress disorder (PTSD). Specifically, administration of oxytocin has been shown to facilitate fear extinction in humans. Similarly, substances that release serotonin and oxytocin such as MDMA have been shown to enhance the extinction of fear memory in animals. However, there are no data on the effects of MDMA on fear extinction in humans. Therefore, the primary aim of this study is to investigate the role of acute serotonin release in the effects of fear extinction. MDMA will be used as pharmacological tool to induce serotonin release in this study.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: MDMA
    125 mg MDMA per os, single dose
    Other Name: 3,4-Methylenedioxymethamphetamine
  • Drug: Placebo
    Capsules containing mannitol looking identical to the other drugs.
Study Arms  ICMJE
  • Experimental: MDMA, Placebo
    Cross-over within-subjects design with both treatment conditions, separated by a wash-out phase
    Interventions:
    • Drug: MDMA
    • Drug: Placebo
  • Experimental: Placebo, MDMA
    Cross-over within-subjects design with both treatment conditions, separated by a wash-out phase
    Interventions:
    • Drug: MDMA
    • Drug: Placebo
Publications * Vizeli P, Straumann I, Duthaler U, Varghese N, Eckert A, Paulus MP, Risbrough V, Liechti ME. Effects of 3,4-Methylenedioxymethamphetamine on Conditioned Fear Extinction and Retention in a Crossover Study in Healthy Subjects. Front Pharmacol. 2022 Jul 13;13:906639. doi: 10.3389/fphar.2022.906639. eCollection 2022.

*   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: May 4, 2018)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 24, 2020
Actual Primary Completion Date December 10, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male
  • Age between 18 and 50 years.
  • Understanding of the German language.
  • Understanding the procedures and the risks associated with the study.
  • Participants must be willing to adhere to the protocol and sign the consent form.
  • Participants must be willing to refrain from taking illicit psychoactive substances during the study.
  • Participants must be willing to drink only alcohol-free liquids and no coffee, black or green tea, or energy drink after midnight of the evening before the study session, as well as during the study day.
  • Participants must be willing not to drive a traffic vehicle or to operate machines within 48 h after substance administration.
  • Body mass index 18-29 kg/m2.

Exclusion Criteria:

  • Chronic or acute medical condition
  • Hypertension (>140/90 mmHg) or hypotension (SBP<85 mmHg)
  • Current or previous major psychiatric disorder
  • Psychotic disorder in first-degree relatives
  • Illicit substance use (with the exception of cannabis) of more than 5 times or any time within the previous month.
  • Participation in another clinical trial (currently or within the last 30 days)
  • Use of medications that may interfere with the effects of the study medications (any psychiatric medications)
  • Tobacco smoking (>10 cigarettes/day)
  • Consumption of alcoholic standard drinks (>10/week or >120 g ethanol/week)
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03527316
Other Study ID Numbers  ICMJE BASEC 2017-01947
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party University Hospital, Basel, Switzerland
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University Hospital, Basel, Switzerland
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Matthias E Liechti, MD, MAS University Hospital, Basel, Switzerland
PRS Account University Hospital, Basel, Switzerland
Verification Date January 2022

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