Effects of MDMA Co-administration on the Response... — Clinical Trial Details

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.

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:
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)

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

Detailed Description

Study Protocol

Preparation

Dosing

Locations

Related Publications

Acute effects of MDMA and LSD co-administration in a double-blind placebo-controlled study in healthy participants

Integration

Study Arms & Interventions

LSD + MDMA placebo

Interventions

MDMA + LSD placebo

Interventions

LSD + MDMA

Interventions

LSD placebo + MDMA placebo

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details

Study Team

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