Brief description of trial (Data source: BASEC)
Die Studie untersucht die veränderte Angstverarbeitung während erhöhter Serotoninfreisetzung, ausgelöst durch MDMA.
An dieser Studie werden insgesamt 30 gesunde, männliche Versuchspersonen teilnehmen. Die Studie wird gemäss den geltenden Schweizer Gesetzen und international anerkannten Grundsätzen durchgeführt. Die Studie wurde von der lokalen Ethikkommission genehmigt.
Health conditions investigated(Data source: BASEC)
Gesunde, männliche, freiwillige Probanden
Health conditions
(Data source: WHO)
Healthy
Rare disease
(Data source: BASEC)
No
Intervention investigated (e.g. drug, therapy or campaign)
(Data source: BASEC)
Die Studie umfasst eine Eintrittsuntersuchung à 2h sowie zwei Studientage à jeweils 8h plus 1.5h Visite am Folgetag. An den Studientagen erhalten sie jeweils einmalig Placebo (Malzzucker) oder 125 mg MDMA in zufälliger und weder dem Prüfarzt noch Ihnen bekannter Reihenfolge. Während den Studientagen werden wiederholt Messungen (Fragebogen, Blutentnahmen, Blutdruck, Puls, Computertests mit Messung der Muskelaktivität und des Hautwiderstandes) durchgeführt. Dazu kommt eine Abschlussuntersuchung à 1h. Der Abstand zwischen beiden Studientagen beträgt mind. 30 Tage. Insgesamt dauert die Studie für Sie ca. 7-10 Wochen.
Interventions
(Data source: WHO)
Drug: MDMA;Drug: Placebo
Criteria for participation in trial
(Data source: BASEC)
Männlich, gesund und zwischen 18 und 50 Jahre alt.
Exclusion criteria
(Data source: BASEC)
Weiblich, aktuelle oder vergangene psychotische Störungen, chronische oder akute Krankheiten
Inclusion/Exclusion Criteria
(Data source: WHO)
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)
-
Further information on trial
Date trial registered
May 4, 2018
Incorporation of the first participant
Oct 18, 2019
Recruitment status
Completed
Academic title
(Data source: WHO)
Effect of MDMA (Serotonin Release) on Fear Extinction
Type of trial
(Data source: WHO)
Interventional
Design of the trial
(Data source: WHO)
Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Basic Science. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
Phase
(Data source: WHO)
Early Phase 1
Primary end point
(Data source: WHO)
Fear extinction measured by Skin conductance response;Fear extinction measured by Fear-potentiated startle
Secundary end point
(Data source: WHO)
Plasma concentration of Oxytocin;Subjective effects measured by Visual analog scales;Autonomic effects measured by Blood pressure;Autonomic effects measured by Hearth rate;Autonomic effects measured by Body temperature;Subjective effects measured by State-trait anxiety inventory for state (STAI-S);Plasma concentration of MDMA
Contact information
(Data source: WHO)
Please refer to primary and secondary sponsors
Trial results
(Data source: WHO)
Results summary
no information available yet
Link to the results in the primary register
no information available yet
Information on the availability of individual participant data
no information available yet
Trial sites
Trial sites in Switzerland
(Data source: BASEC)
Basel
Countries
(Data source: WHO)
Switzerland
Contact for further information on the trial
Details of contact in Switzerland
(Data source: BASEC)
Prof.Dr.med. Matthias Liechti
061 328 68 68
matthias.liechti@usb.ch
Contact for general information
(Data source: WHO)
Matthias E Liechti, MD, MAS
University Hospital, Basel, Switzerland
Contact for scientific information
(Data source: WHO)
Matthias E Liechti, MD, MAS
University Hospital, Basel, Switzerland
Authorisation by the ethics committee (Data source: BASEC)
Name of the authorising ethics committee (for multicentre studies only the lead committee)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
Date of authorisation by the ethics committee
16.01.2018
Further trial identification numbers
Trial identification number of the ethics committee (BASEC-ID)
(Data source: BASEC)
2017-01947
Secondary ID (Data source: WHO)
BASEC 2017-01947
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