Acute Effects of 3,4-methylenedioxymethamphetamine (MDMA) With and Without a Booster Dose

NCT05809271 | Completed Phase 1 DMC

• 1 other identifier: BASEC 2023-00167
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

3,4-methylenedioxymethamphetamine (MDMA) is a psychoactive substance and prototypical empathogen acutely inducing feelings of heightened mood, empathy, trust and closeness to others. The current study investigates differences in duration of acute effects and side effects after administration of a single dose of MDMA compared to a repeated administration.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Subjective effect duration for "any drug effect"

  Assessed by visual analog scale (VAS) using 10% of the individual maximal subjective response (Emax) as threshold for the onset and offset.

  Every 15 minutes for 9 hours after substance administration

Secondary Outcomes (24)

• Maximal subjective effects for "any drug effect"

  Every 15 minutes for 9 hours after substance administration

• Total subjective effects for "any drug effect"

  Every 15 minutes for 9 hours after substance administration

• Further acute subjective effects I duration

  Every 30 minutes for 9 hours after substance administration

• Further acute subjective effects II maximal effects

  Every 30 minutes for 9 hours after substance administration

• Further acute subjective effects III total effects

  Every 30 minutes for 9 hours after substance administration

Study Arms (3)

MDMA with booster

EXPERIMENTAL

MDMA followed by MDMA

Drug: MDMA 120 mg + MDMA 60 mg

MDMA without booster

EXPERIMENTAL

MDMA followed by placebo

Drug: MDMA 120 mg + placebo

Placebo

PLACEBO COMPARATOR

Placebo followed by placebo

Drug: Placebo

Interventions

MDMA 120 mg + MDMA 60 mg DRUG

An oral dose of 120 mg racemic MDMA will be administered followed by a second dose of 60 mg racemic MDMA two hours later.

Also known as: 3,4-Methylenedioxymethamphetamine

MDMA with booster

MDMA 120 mg + placebo DRUG

An oral dose of 120 mg racemic MDMA will be administered followed by a placebo two hours later.

Also known as: 3,4-Methylenedioxymethamphetamine

MDMA without booster

Placebo DRUG

An oral placebo will be administered followed by a placebo two hours later.

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:

• Good 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 drinks 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 48h after substance administration.
• Willing to use effective birth control throughout study participation.
• Body mass index between 18-29 kg/m2.

You may not qualify if:

• Relevant 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).
• Previous MDMA use 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, 4031, Switzerland

Location

MeSH Terms

Interventions

N-Methyl-3,4-methylenedioxyamphetamine

Intervention Hierarchy (Ancestors)

Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Study Officials

• Matthias E Liechti, Prof. Dr. 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: 3-period, random order, placebo-controlled, double-blind cross-over study

Study Record Dates

• First Submitted: March 13, 2023
• First Posted: April 12, 2023
• Study Start: November 17, 2023
• Primary Completion: March 7, 2025
• Study Completion: March 7, 2025
• Last Updated: March 19, 2025

Record last verified: 2025-03

Locations

CH (1)