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Completed

NCT Number: NCT03527316

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

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.

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Key information

Conditions

Healthy

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Early Phase 1

Primary location

Clinical Pharmacology & Toxicology, University Hospital Basel

Basel, 4056, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

MDMA

Drug

125 mg MDMA per os, single dose

Other names: 3,4-Methylenedioxymethamphetamine

Placebo

Drug

Capsules containing mannitol looking identical to the other drugs.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

Effect of MDMA (Serotonin Release) on Fear Extinction

Acronym: MFE

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 17, 2018
Registry last updated
Jan 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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