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Acute Effects of R- and S-MDMA in Healthy Subjects

NCT05277636 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2024-01-17

No results posted yet for this study

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 acute subjective effects of MDMA may be helpful to assist psychotherapy and MDMA is currently investigated in phase 3 trials as a possible treatment in post-traumatic stress disorder.

Conditions

  • Healthy

Interventions

DRUG

3,4-methylenedioxymethamphetamine

A dose of 125 mg racemic MDMA will be administered.

DRUG

S-3,4-methylenedioxymethamphetamine

A dose of 125 mg enantiomeric S-MDMA will be administered.

DRUG

R-3,4-methylenedioxymethamphetamine (125 mg)

A dose of 125 mg enantiomeric R-MDMA will be administered.

DRUG

R-3,4-methylenedioxymethamphetamine (250 mg)

A dose of 250 mg enantiomeric R-MDMA will be administered.

OTHER

Placebo

Placebo (Mannitol)

Sponsors & Collaborators

  • University Hospital, Basel, Switzerland

    lead OTHER

Principal Investigators

  • Matthias E Liechti, MD · University Hospital Basel, Basel, Switzerland

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-01
Primary Completion
2024-01-13
Completion
2024-01-13

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05277636 on ClinicalTrials.gov