Recruiting PHASE1 Healhty

New treatment option for Healhty

Official title Acute Analgesic Effects of MDMA on Experimentally Induced Acute Pain, Hyperalgesia and Allodynia in Healthy Participants

ClinicalTrials.gov ID: NCT07494214

What this study is testing

What is MDMA 25 mg?

MDMA 25 mg is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for healhty.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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).
  • Phase 1: an early, usually small safety study
  • You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 75. Healthy volunteers may be eligible.

You may be able to join 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

You likely can't join 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
See the full eligibility criteria
Who can join
  • 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
What rules you out
  • 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)

The study team makes the final eligibility decision.

Where it's taking place

  • Basel, Switzerland

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years to 75 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Basel, Switzerland. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.