Comparative Acute Effects of R-MDMA and S-MDMA in Healthy Participants

NCT06905652 | Recruiting Phase 1

• 1 other identifier: BASEC 2024-01835
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Subjective effects

  Any drug effect on the Visual Analog Scales (VAS) assessing the intensity and duration of the subjective effect on a scale from 0 - 100 percent with higher scores representing more intense effects 14 times each study day.

  through study completion, an average of 18 months.

Secondary Outcomes (27)

• Autonomic effects I

  Through study completion, an average of 18 months.

• Autonomic effects II

  Through study completion, an average of 18 months.

• Autonomic effects III

  through study completion, an average of 18 months.

• Plasma levels of oxytocin

  Through study completion, an average of 18 months.

• Plasma levels of cortisol

  Through study completion, an average of 18 months.

Study Arms (3)

300mg R-MDMA

EXPERIMENTAL

R-MDMA (300mg)

Drug: R-3,4-methylenedioxymethamphetamine

100mg S-MDMA

EXPERIMENTAL

S-MDMA (100mg)

Drug: S-3,4-methylenedioxymethamphetamine

Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

R-3,4-methylenedioxymethamphetamine DRUG

A dose of 300mg enantiomeric R-MDMA will be administered.

Also known as: R-MDMA

300mg R-MDMA

S-3,4-methylenedioxymethamphetamine DRUG

A dose of 100mg enantiomeric S-MDMA will be administered.

Also known as: S-MDMA

100mg S-MDMA

Placebo OTHER

Placebo (Mannitol)

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 65 years
• Good 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
• Willing not to operate heavy machinery within 48 h after administration of a study substance (including driving a car)
• Willing to use effective birth-control throughout study participation.
• Body mass index 18 - 34.9 kg/m2

You may not qualify if:

• Relevant chronic or acute medical condition
• Current or previous major psychiatric disorder (e.g. bipolar disorder, schizophrenia), current depression or anxiety disorder
• Psychotic disorder or bipolar disorder in first-degree relatives
• 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.
• Pregnancy or current breastfeeding
• Participation in another clinical trial (currently or within the last 30 days)
• Use of medications that may interfere with the effects of the study medication
• Tobacco smoking (\>10 cigarettes/day).
• Excessive consumption of alcoholic beverages (\>15 drinks/week)

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

RECRUITING

Study Officials

• Matthias E Liechti, Prof. Dr. MD

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthias E Liechti, Prof. Dr. MD

CONTACT

61 328 68 68; matthias.liechti@usb.ch

Carolin R Mayer

CONTACT

61 328 68 65; carolinrenate.mayer@usb.ch

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: double-blind, placebo-controlled, 3-period cross-over design with two treatment conditions and placebo: 1. R-MDMA (300mg), 2. S-MDMA (100mg), 3. Placebo

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: April 1, 2025
• Study Start: July 29, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: July 30, 2025

Record last verified: 2025-07

Locations

CH (1)