Effects of MDMA on Psilocybin Response in Healthy Adults

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

This study is testing if taking MDMA with psilocybin can make the experience more positive and less anxious for healthy adults.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 25 Years to 65 Years
• Sex: All
• Sponsor: University Hospital, Basel, Switzerland (Academic / other)
• Locations: 1 site (Basel)
• Trial ID: NCT06884514 on ClinicalTrials.gov

What this trial studies

This study investigates how the co-administration of MDMA affects the subjective experience of psilocybin in healthy individuals. It aims to explore whether MDMA can enhance positive effects such as mood and empathy while reducing negative effects like anxiety and paranoia associated with psilocybin use. Participants will receive either psilocybin or a placebo, alongside MDMA or its placebo, in a controlled setting. The study focuses on understanding the acute psychological effects and optimizing the therapeutic potential of psilocybin.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 25 to 65 who can understand German and meet specific health criteria.

Not a fit: Patients with chronic or acute medical conditions or a history of major psychiatric disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved therapeutic outcomes for patients using psychedelics for mental health treatment by minimizing negative psychological effects.

How similar studies have performed: While the combination of MDMA and psilocybin is a novel approach, previous studies have shown promising results with individual psychedelics in therapeutic settings.

Eligibility criteria

Inclusion Criteria:

1. Age between 25 and 65 years.
2. Understanding of the German language.
3. Understanding the procedures and the risks that are associated with the study.
4. Participants must be willing to adhere to the protocol and sign the consent form.
5. Participants must be willing to refrain from taking illicit psychoactive substances during the study.
6. Participants must be willing to drink only alcohol-free liquids and no coffee, black or green tea, or energy drink after midnight of the evening before the study session, as well as during the study day.
7. Participants must be willing not to drive a traffic vehicle or to operate machines within 48 h after substance administration.
8. Willing to use effective 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 in first-degree relatives, not including psychotic disorders secondary to an apparent medical reason, e.g. brain injury, dementia, or lesions of the brain.
4. Hypertension (SBP\>140/90 mmHg) or hypotension (SBP\<85 mmHg)
5. Illicit substance use (not including cannabis) more than 20 times or any time within the previous month
6. Pregnant or nursing women.
7. Participation in another clinical trial (currently or within the last 30 days).
8. Use of medications that may interfere with the effects of the study medications.
9. Tobacco smoking (\>10 cigarettes/day).
10. Consumption of alcoholic drinks (\>15 drinks/week).

Where this trial is running

Basel

• University Hospital Basel — Basel, Switzerland (Recruiting)

Study contacts

• Principal investigator: Matthias E Liechti, Prof. Dr. MD — University Hospital Basel, Basel, Switzerland
• Study coordinator: Matthias E Liechti, Prof. Dr. MD

Conditions Healthy