Acute Effects of 2C-B Compared With MDMA and Psilocybin in Healthy Subjects

Launched by UNIVERSITY HOSPITAL, BASEL, SWITZERLAND · Aug 29, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a substance called 2C-B, which is similar to MDMA (commonly known as Ecstasy) and psilocybin (found in magic mushrooms). Researchers want to understand how 2C-B affects healthy people compared to these other substances. All three have unique effects on the brain, and this study aims to gather scientific information about 2C-B, which is not well understood yet.

To be eligible for this trial, participants should be between 25 and 65 years old, speak German well, and be in good health without any serious medical or psychiatric conditions. They must also agree to avoid illegal drugs and alcohol before and during the study. Participants will take 2C-B in a controlled setting and will be monitored for its effects. It's important to note that women who could become pregnant will need to take pregnancy tests and use double-barrier birth control during the study. Overall, this trial is a chance to contribute to research on new substances that might have therapeutic benefits.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age between 25 and 65 years.
• • Sufficient understanding of the German language.
• • Understanding the procedures and the risks that are associated with the study.
• • Participants must be willing to adhere to the protocol and sign the consent form.
• • Participants must be willing to refrain from taking illicit psychoactive substances during the study.
• • 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.
• • Participants must be willing not to drive a traffic vehicle or to operate machines within 48 h after substance administration.
• • Women of childbearing potential must have a negative pregnancy test at the beginning of the study. Pregnancy tests are repeated before each study session.
• • Women of childbearing potential must be willing to use double-barrier birth control.
• • Body mass index between 18-29kg/m2
• Exclusion Criteria:
• • Chronic or acute medical condition, including a history of seizures.
• • Current or previous major psychiatric disorder (e.g. psychotic disorders, mania / hypomania, anxiety disorders).
• • Psychotic or bipolar 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.
• • Hypertension (SBP\>140/90 mmHg) or hypotension (SBP\<85 mmHg)
• • Ilicit substance use (with the exception of cannabis) more than 20 times or any time within the previous two months
• • Pregnant or nursing women.
• • Participation in another clinical trial (currently or within the last 30 days).
• • Use of medications that may interfere with the effects of the study medications (any psychiatric medications and any medication with known to interact with the study substances).
• • Tobacco smoking (\>10 cigarettes/day).
• • Consumption of alcoholic drinks (\>20 drinks / week).
• • Body weigt \< 45 kg.