Clinical TrialHealthy VolunteersLSDPlaceboMDMAPlaceboLSDMDMAPlaceboPlaceboCompleted

Effects of MDMA Co-administration on the Response to LSD in Healthy Subjects

This completed double-blind, placebo-controlled trial (n=24) aimed to investigate the effects of co-administering MDMA with LSD in healthy subjects. The study, conducted by the University Hospital in Basel, Switzerland, assessed the acute subjective and autonomic effects of LSD alone and in combination with MDMA.

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

Detailed Description

Rationale: MDMA reliably increases positive mood, empathy and trust and may reduce anxiety during classic psychedelic (LSD) experiences; this study tested whether MDMA coadministration improves the subjective valence and autonomic profile of LSD in healthy volunteers.

Design: Randomized, triple-masked, double-blind, 4-period crossover (100 µg LSD and 100 mg MDMA in all combinations versus double placebo) assessing acute subjective and autonomic outcomes in 24 healthy adults.

Study Protocol

Preparation

sessions

Dosing

4 sessions

Integration

sessions

Study Arms & Interventions

LSD + MDMA placebo

experimental

100 µg LSD with MDMA placebo (single dose).

Interventions

  • LSD100 µg
    via Oral• single dose• 1 doses total
  • Placebo
    via Oral• single dose• 1 doses total

    MDMA placebo (mannitol)

MDMA + LSD placebo

experimental

100 mg MDMA with LSD placebo (single dose).

Interventions

  • MDMA100 mg
    via Oral• single dose• 1 doses total
  • Placebo
    via Oral• single dose• 1 doses total

    LSD placebo (alcohol solution)

LSD + MDMA

experimental

100 µg LSD with 100 mg MDMA (single dose).

Interventions

  • LSD100 µg
    via Oral• single dose• 1 doses total
  • MDMA100 mg
    via Oral• single dose• 1 doses total

LSD placebo + MDMA placebo

inactive

Double placebo comparator (LSD placebo + MDMA placebo).

Interventions

  • Placebo
    via Oral• single dose• 1 doses total

    LSD placebo (alcohol solution)

  • Placebo
    via Oral• single dose• 1 doses total

    MDMA placebo (mannitol)

Participants

Ages
25 – 65
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • 1. Age between 25 and 65 years old
  • 2. Sufficient understanding of the German language
  • 3. Understanding of procedures and risks associated with the study
  • 4. Willing to adhere to the protocol and signing of the consent form
  • 5. Willing to refrain from the consumption of illicit psychoactive substances during the study
  • 6. Abstaining from xanthine-based liquids from the evenings prior to the study sessions and during the sessions
  • 7. Willing not to operate heavy machinery within 48 h of substance administration
  • 8. Willing to use double-barrier birth control throughout study participation
  • 9. Body mass index between 18-29 kg/m2

Exclusion Criteria

  • Exclusion Criteria:
  • 1. Chronic or acute medical condition
  • 2. Current or previous major psychiatric disorder
  • 3. Psychotic disorder or bipolar disorder in first-degree relatives
  • 4. Hypertension (SBP>140/90 mmHg) or hypotension (SBP<85 mmHg)
  • 5. Use of hallucinogenic substances (not including cannabis) more than 20 times or any time within the previous two months
  • 6. Use of MDMA more than 20 times or any time within the previous two months
  • 7. Pregnancy or currently breastfeeding
  • 8. Participation in another clinical trial (currently or within the last 30 days)
  • 9. Use of medication that may interfere with the effects of the study medication
  • 10. Tobacco smoking (>10 cigarettes/day)
  • 11. 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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