Acute Effects of MDMA Co-administration on the Response to Psilocybin in Healthy Subjects
Sponsored by University Hospital, Basel, Switzerland
About This Study
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 Studied
Interventions
- •Psilocybin
- •3,4-Methylenedioxymethamphetamine
- •Psilocybin placebo
- •3,4-Methylenedioxymethamphetamine placebo
Eligibility
View full 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).