Status:
COMPLETED
Effects of MDMA-like Substances in Healthy Subjects
Lead Sponsor:
University Hospital, Basel, Switzerland
Conditions:
Healthy
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The serotonin (5-HT) and oxytocin releaser and so-called "empathogen" 3,4-methylenedioxymethamphetamine (MDMA) acutely produces positive feelings, empathy, and trust. MDMA is used recreationally (ecst...
Detailed Description
3,4-methylenedioxymethamphetamine (MDMA) is used as recreational substance (Ecstasy), research tool to stimulate serotonin (5-HT) and oxytocin release and study associated mood states, and as a potent...
Eligibility Criteria
Inclusion
- Age between 18 and 65 years old
- Sufficient understanding of the German language
- Understanding of procedures and risks associated with the study
- Willing to adhere to the protocol and signing of the consent form
- Willing to refrain from the consumption of illicit psychoactive substances during the study
- Abstaining from xanthine-based liquids from the evenings prior to the study sessions to the end of the study days
- Willing not to operate heavy machinery within 48 hours 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 or bipolar disorder in first-degree relatives
- Hypertension (\>140/90 mmHg) or hypotension (SBP\<85 mmHg)
- Hallucinogenic substance or MDMA use more than 20 times or use of any illicit substance within the previous two months (not including cannabis)
- Pregnancy or current breastfeeding
- Participation in another clinical trial (currently or within the last 30 days)
- Use of medication that may interfere with the effects of the study medication
- Tobacco smoking (\>10 cigarettes/day)
- Consumption of alcoholic beverages (\>20 drinks/week)
Key Trial Info
Start Date :
December 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 18 2024
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT04847206
Start Date
December 1 2021
End Date
June 18 2024
Last Update
August 14 2024
Active Locations (1)
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1
University Hospital Basel, Clinical Trial Unit
Basel, Canton of Basel-City, Switzerland, 4056