Status:
COMPLETED
Acute Effects of R- and S-MDMA in Healthy Subjects
Lead Sponsor:
University Hospital, Basel, Switzerland
Conditions:
Healthy
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
Racemic ±3,4-methylenedioxymethamphetamine (MDMA) is a psychoactive substance and prototypical empathogen acutely inducing feelings of heightened mood, empathy, trust and closeness to others. These ac...
Detailed Description
MDMA is a racemic substance containing equal amounts of the enantiomers S(+)- and R(-)-MDMA. Preclinical research indicates that S-MDMA mainly releases dopamine, norepinephrine, serotonin, and oxytoci...
Eligibility Criteria
Inclusion
- Age between 18 and 65 years.
- Understanding of the German language.
- Understanding the procedures and the risks that are 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.
- Willing to use double-barrier birth control throughout study participation.
- Body mass index between 18-29 kg/m2.
Exclusion
- Chronic or acute medical condition
- Current or previous major psychiatric disorder
- Psychotic disorder in first-degree relatives, not including psychotic disorders secondary to an apparent medical reason, e.g. brain injury, dementia, or lesions of the brain.
- Hypertension (SBP\>140/90 mmHg) or hypotension (SBP\<85 mmHg)
- Illicit substance use (not including cannabis) more than 20 times or any time within the previous month
- Pregnant or nursing women.
- 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.
- Tobacco smoking (\>10 cigarettes/day).
- Consumption of alcoholic drinks (\>15 drinks/week).
Key Trial Info
Start Date :
October 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 13 2024
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT05277636
Start Date
October 1 2022
End Date
January 13 2024
Last Update
January 17 2024
Active Locations (1)
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1
University Hospital Basel
Basel, Switzerland