Acute Effects of MDMA Co-administration on the Response to Psilocybin in Healthy Subjects
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 consumin
| Condition(s) | Healthy |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| 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 admin |
| Who can participate | 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 betwe |
| Ages | 25 Years to 65 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | University Hospital, Basel, Switzerland |
| Locations | Basel, Switzerland |
| Start date | 2025-04-03 |
| NCT ID | NCT06884514 |
| Official listing | https://clinicaltrials.gov/study/NCT06884514 |