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RECRUITING
NCT06884514
PHASE1

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

Sponsor: University Hospital, Basel, Switzerland

View on ClinicalTrials.gov

Summary

The acute subjective effects of serotonin (5-HT)2A receptor stimulation with psilocybin in humans are mostly positive. However, negative effects such as anxiety, paranoid thinking, or loss of trust towards other people are common effects, depending on the dose administered, the personality traits of the person consuming it (set), or the environment in which psilocybin is taken (setting). Negative psychedelic effects may cause acute distress to the subject and acute anxiety has been linked to less favorable long-term outcomes in patients experimentally treated with psilocybin or similar substances for the treatment of depression. The 5-HT and oxytocin releaser 3,4-methylenedioxymethamphetamine (MDMA) reliably induces positive mood, euphoria, comfort, empathy, and feelings of trust. If administered in combination with psilocybin, MDMA may increase positive subjective drug effects including positive mood, empathy, and trust and reduce negative emotions and anxiety associated with psilocybin and overall produce a more positive over negative experience. The present study will assess subjective and autonomic effects of psilocybin alone and in combination with MDMA.

Key Details

Gender

All

Age Range

25 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2025-04-03

Completion Date

2026-07-01

Last Updated

2025-05-21

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

Psilocybin

A moderate dose of 20 mg psilocybin will be administered.

DRUG

3,4-Methylenedioxymethamphetamine

A moderate dose of 100 mg MDMA will be administered.

DRUG

Psilocybin placebo

Mannitol capsules instead of capsules containing psilocybin.

DRUG

3,4-Methylenedioxymethamphetamine placebo

Mannitol capsules instead of capsules containing MDMA.

Locations (1)

University Hospital Basel

Basel, Switzerland