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

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ClinicalTrials.gov Identifier: NCT03527316
Recruitment Status : Not yet recruiting
First Posted : May 17, 2018
Last Update Posted : November 7, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: MDMA Drug: Placebo Early Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effect of MDMA (Serotonin Release) on Fear Extinction
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Club Drugs
Drug Information available for: Serotonin

Arm Intervention/treatment
Placebo Comparator: MDMA, Placebo
Cross-over within-subjects design with both treatment conditions, separated by a wash-out phase
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.

Placebo Comparator: Placebo, MDMA
Cross-over within-subjects design with both treatment conditions, separated by a wash-out phase
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.




Primary Outcome Measures :
  1. Fear extinction measured by Skin conductance response [ Time Frame: 12 months ]
    a) Skin conductance response to conditioned stimuli

  2. Fear extinction measured by Fear-potentiated startle [ Time Frame: 12 months ]
    b) Fear-potentiated startle to conditioned stimuli


Secondary Outcome Measures :
  1. Plasma concentration of Oxytocin [ Time Frame: 12 months ]
  2. 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'

  3. Autonomic effects measured by Blood pressure [ Time Frame: 12 months ]
    Autonomic effects measured by vital signs

  4. Autonomic effects measured by Hearth rate [ Time Frame: 12 months ]
    Autonomic effects measured by vital signs

  5. Autonomic effects measured by Body temperature [ Time Frame: 12 months ]
    Autonomic effects measured by vital signs

  6. Subjective effects measured by State-trait anxiety inventory for state (STAI-S) [ Time Frame: 12 months ]
  7. Plasma concentration of MDMA [ Time Frame: 12 months ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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)

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): NCT03527316


Contacts
Contact: Matthias E Liechti, MD, MAS 61 328 68 68 ext +41 matthias.liechti@usb.ch
Contact: Patrick Vizeli, MSc 61 556 54 22 ext +41 patrick.vizeli@usb.ch

Locations
Switzerland
Clinical Pharmacology & Toxicology, University Hospital Basel Not yet recruiting
Basel, Switzerland, 4056
Contact: Matthias E Liechti, Prof.Dr.med.    +41 61 265 88 68 ext +41    matthias.liechti@usb.ch   
Contact: Patrick Vizeli, MSc    +41 61 556 54 22 ext +41    patrick.vizeli@usb.ch   
Principal Investigator: Matthias E Liechti, MD         
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Principal Investigator: Matthias E Liechti, MD, MAS University Hospital, Basel, Switzerland

Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT03527316     History of Changes
Other Study ID Numbers: BASEC 2017-01947
First Posted: May 17, 2018    Key Record Dates
Last Update Posted: November 7, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

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