NCT07494214

Brief Summary

This study investigates whether MDMA may have a pain-reducing effect. The effect of MDMA is compared with a placebo (a substance with no active effect). In the study, moderate pain will be artificially created in healthy participants using repeated small electrical pulses applied under the skin. At the same time, participants will take MDMA or a placebo by mouth. This allows researchers to compare how MDMA affects the artificially created pain. A total of 20 healthy volunteers will take part in this study.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
10mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress25%
Mar 2026Apr 2027

First Submitted

Initial submission to the registry

March 9, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

March 9, 2026

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 27, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 9, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 9, 2027

Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

1 year

First QC Date

March 9, 2026

Last Update Submit

March 19, 2026

Conditions

Healhty

Outcome Measures

Primary Outcomes (1)

  • NRS

    Difference of the cumulative NRS scores (area under the effect curves, AUECs) between the MDMA 125 mg and placebo condition.

    Periprocedural

Secondary Outcomes (4)

  • Hyperalgesia and Allodnyia

    Periprocedural

  • Subjective effects and NRS ratings

    Periprocedural

  • Endocrine effects

    Periprocedural

  • NRS dose-dependent effects

    Periprocedural

Study Arms (4)

MDMA 25 mg

EXPERIMENTAL
Drug: MDMA 25 mg

MDMA 75 mg

EXPERIMENTAL
Drug: MDMA 75 mg

MDMA 125 mg

EXPERIMENTAL
Drug: MDMA 125 mg

Placebo

EXPERIMENTAL
Drug: Placebo

Interventions

MDMA 25 mgDRUG

oral administration

MDMA 25 mg
MDMA 75 mgDRUG

oral administration

MDMA 75 mg
MDMA 125 mgDRUG

oral administration

MDMA 125 mg
PlaceboDRUG

oral administration

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18 and 75 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
  • Willing not to operate heavy machinery for 48 hours after the study session.
  • Willing to use effective birth control throughout study participation
  • Body mass index between 18-34.9 kg/m2

You may not qualify if:

  • Relevant chronic or acute medical condition
  • Any implanted medical devices (e.g., pacemakers, neurostimulators, or metal prostheses)
  • 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)
  • Lifetime use of MDMA on more than 20 occasions or any use within the previous two months
  • 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 (\>15 drinks/week)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Pharmacology & Toxicology, University Hospital Basel

Basel, 4056, Switzerland

RECRUITING

MeSH Terms

Interventions

N-Methyl-3,4-methylenedioxyamphetamine

Intervention Hierarchy (Ancestors)

AmphetaminesPhenethylaminesEthylaminesAminesOrganic Chemicals

Central Study Contacts

Severin B Vogt, Dr. med.

CONTACT

+41 61 268 68 66severinbenjamin.vogt@usb.ch

Matthias E Liechti, Prof.

CONTACT

+41 61 268 68 86matthias.liechti@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

Study Record Dates

First Submitted

March 9, 2026

First Posted

March 27, 2026

Study Start

March 9, 2026

Primary Completion (Estimated)

March 9, 2027

Study Completion (Estimated)

April 9, 2027

Last Updated

March 27, 2026

Record last verified: 2026-03

Locations

CH(1)