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

NCT05277636 | Completed Phase 1

• 1 other identifier: BASEC 2021-02386
• 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 is currently investigated in phase 3 trials as a possible treatment in post-traumatic stress disorder.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Subjective effects I

  5 Dimensions of Altered States of Consciousness (5D-ASC) consisting of 94 items to be rated on a visual analog scale (0-100 mm), with higher values indicating stronger effects with higher scores representing more intense effects. Assessed once on each study day

  18 months

• Subjective effects II

  Stimulation on the Visual Analog Scales (VAS) assessing the intensity and duration of the stimulant effect on a scale from 0 - 100 percent with higher scores representing more intense effects. Assessed 18 times on each study day

  18 months

Secondary Outcomes (26)

• Autonomic effects I

  18 months

• Autonomic effects II

  18 months

• Autonomic effects III

  18 months

• Adverse effects

  18 months

• Mood after study day I

  18 months

Study Arms (5)

125 mg MDMA

EXPERIMENTAL

MDMA (125 mg)

Drug: 3,4-methylenedioxymethamphetamine

125 mg S-MDMA

EXPERIMENTAL

S-MDMA (125 mg)

Drug: S-3,4-methylenedioxymethamphetamine

125 mg R-MDMA

EXPERIMENTAL

R-MDMA (125 mg)

Drug: R-3,4-methylenedioxymethamphetamine (125 mg)

250 mg R-MDMA

EXPERIMENTAL

R-MDMA (250 mg)

Drug: R-3,4-methylenedioxymethamphetamine (250 mg)

Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

3,4-methylenedioxymethamphetamine DRUG

A dose of 125 mg racemic MDMA will be administered.

Also known as: MDMA

125 mg MDMA

S-3,4-methylenedioxymethamphetamine DRUG

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

Also known as: S-MDMA

125 mg S-MDMA

R-3,4-methylenedioxymethamphetamine (125 mg) DRUG

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

Also known as: R-MDMA

125 mg R-MDMA

R-3,4-methylenedioxymethamphetamine (250 mg) DRUG

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

Also known as: R-MDMA

250 mg R-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.
• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel

Basel, Switzerland

Location

Related Publications (1)

• Straumann I, Avedisian I, Klaiber A, Varghese N, Eckert A, Rudin D, Luethi D, Liechti ME. Acute effects of R-MDMA, S-MDMA, and racemic MDMA in a randomized double-blind cross-over trial in healthy participants. Neuropsychopharmacology. 2024 Dec;50(2):362-371. doi: 10.1038/s41386-024-01972-6. Epub 2024 Aug 23.

  PMID: 39179638 DERIVED

MeSH Terms

Interventions

N-Methyl-3,4-methylenedioxyamphetamine

Intervention Hierarchy (Ancestors)

Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Study Officials

• Matthias E Liechti, MD

  University Hospital Basel, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

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: 5-period random order, placebo-controlled, double-blind cross-over study with four active substance conditions and placebo: 1\. MDMA (125 mg), 2. S-MDMA (125 mg), 3. R-MDMA (125 mg), 4. R-MDMA (250 mg), 5. Placebo

Study Record Dates

• First Submitted: March 3, 2022
• First Posted: March 14, 2022
• Study Start: October 1, 2022
• Primary Completion: January 13, 2024
• Study Completion: January 13, 2024
• Last Updated: January 17, 2024

Record last verified: 2022-11

Locations

CH (1)