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

Healthy Clinical Trial

— MFE  

Official title:

Effect of MDMA (Serotonin Release) on Fear Extinction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03527316
• Other study ID #: BASEC 2017-01947
• Status: Completed
• Phase: Early Phase 1
• Start date: October 18, 2019
• Est. completion date: December 24, 2020

Study information

• Verified date: January 2022
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 24, 2020
• Est. primary completion date: December 10, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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)

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• MDMA
125 mg MDMA per os, single dose
• Placebo
Capsules containing mannitol looking identical to the other drugs.

Locations

Country	Name	City	State
Switzerland	Clinical Pharmacology & Toxicology, University Hospital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fear extinction measured by Skin conductance response	a) Skin conductance response to conditioned stimuli	12 months
Primary	Fear extinction measured by Fear-potentiated startle	b) Fear-potentiated startle to conditioned stimuli	12 months
Secondary	Plasma concentration of Oxytocin		12 months
Secondary	Subjective effects measured by Visual analog scales	Visual analog scales, 0-100, 0 for 'not at all' and 100 for 'extremely'	12 months
Secondary	Autonomic effects measured by Blood pressure	Autonomic effects measured by vital signs	12 months
Secondary	Autonomic effects measured by Hearth rate	Autonomic effects measured by vital signs	12 months
Secondary	Autonomic effects measured by Body temperature	Autonomic effects measured by vital signs	12 months
Secondary	Subjective effects measured by State-trait anxiety inventory for state (STAI-S)		12 months
Secondary	Plasma concentration of MDMA		12 months