Clinical TrialHealthy VolunteersMDMAPlaceboMDMAPlaceboPlaceboCompleted

Effects of MDMA-like Substances in Healthy Subjects

Phase I randomised, triple‑blind, placebo‑controlled 5‑period crossover in healthy volunteers (n=23) comparing single oral MDMA, MDA, lysine‑MDMA, lysine‑MDA and placebo.

Target Enrollment
23 participants
Study Type
Phase I interventional
Design
Randomized, triple Blind

Detailed Description

This randomized, triple‑blind, placebo‑controlled five‑period crossover in healthy volunteers directly compares the acute effects of MDMA and its metabolite MDA, and their lysine‑linked prodrugs, using single oral doses and modern psychometric and physiological measures.

Aims are to (1) characterise and directly compare subjective, cognitive and physiological effects of MDMA versus MDA and (2) test whether lysine‑conjugation (slow‑release prodrug) attenuates onset and peak effects; outcomes include psychometrics, vitals and safety/tolerability.

Study Protocol

Preparation

sessions

Dosing

5 sessions

Integration

sessions

Study Arms & Interventions

MDMA

experimental

Single oral MDMA dose (MDMA-HCl 100 mg; 84.1 mg free base).

Interventions

  • MDMA84.1 mg
    via Oral• single dose• 1 doses total

    100 mg MDMA‑HCl (=84.1 mg MDMA free base)

MDA

experimental

Single oral MDA dose (93.9 mg MDA‑HCl; 78.0 mg free base).

Interventions

  • Placebo78 mg
    via Oral• single dose• 1 doses total

    93.9 mg MDA‑HCl (=78.0 mg MDA free base); mapped to placeholder compound

lysine‑MDMA

experimental

Single oral lysine‑MDMA prodrug (171.7 mg lysMDMA dihydrochloride; 84.1 mg MDMA free base).

Interventions

  • MDMA84.1 mg
    via Oral• single dose• 1 doses total

    Administered as 171.7 mg lysMDMA dihydrochloride (equals 84.1 mg MDMA free base)

lysine‑MDA

experimental

Single oral lysine‑MDA prodrug (165.6 mg lysMDA dihydrochloride; 78.0 mg MDA free base).

Interventions

  • Placebo78 mg
    via Oral• single dose• 1 doses total

    165.6 mg lysMDA dihydrochloride (equals 78.0 mg MDA free base); mapped to placeholder compound

Placebo

inactive

Placebo (mannitol) comparator.

Interventions

  • Placebo
    via Oral• single dose• 1 doses total

    Placebo (mannitol)

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion Criteria

  • Age between 18 and 65 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
  • Abstaining from xanthine-based liquids from the evenings prior to the study sessions to the end of the study days
  • Willing not to operate heavy machinery within 48 hours after substance administration
  • Willing to use double-barrier birth control throughout study participation
  • Body mass index between 18-29 kg/m2

Exclusion Criteria

  • Chronic or acute medical condition
  • Current or previous major psychiatric disorder
  • Psychotic disorder or bipolar disorder in first-degree relatives
  • Hypertension (>140/90 mmHg) or hypotension (SBP<85 mmHg)
  • Hallucinogenic substance or MDMA use more than 20 times or use of any illicit substance within the previous two months (not including cannabis)
  • 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 (>20 drinks/week)

Study Details

Locations

University Hospital Basel, Clinical Trial Unit — Basel, Canton of Basel-City, Switzerland

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