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

NCT06884514 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-05-21

No results posted yet for this study

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.

Conditions

  • Healthy

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.

Sponsors & Collaborators

  • University Hospital, Basel, Switzerland

    lead OTHER

Principal Investigators

  • Matthias E Liechti, Prof. Dr. MD · University Hospital Basel, Basel, Switzerland

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
25 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-04-03
Primary Completion
2026-07-01
Completion
2026-07-01

Countries

  • Switzerland

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06884514 on ClinicalTrials.gov