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

• Status: Not yet recruiting
• Trial end date: 2024-03-31
• Target enrollment: 0
• Participant gender: All

Summary

2-bromo-2,5-dimethoxyphenethylamine (2C-B) is a psychoactive substance with reportedly similar acute effects to both the prototypical empathogen 3,4-methylenedioxymethamphetamine (MDMA, Ecstasy) and the classic psychedelic substance psilocybin (contained in "magic, hallucinogenic mushrooms"). Pharmacologically, MDMA mainly releases serotonin (5-HT) via the serotonin transporter (SERT) and psilocybin mainly acts as direct agonist at 5-HT2A receptors. 2C-B interacts with both the 5-HT2A receptor and SERT which is in line with its reported mixed effects profile. However, scientific studies are lacking. There is an increased interest in psychiatric research on the therapeutic properties of MDMA and psilocybin and also on mixed empathogenic-psychedelic substances.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University Hospital, Basel, Switzerland
• Treatments: 2-(4-bromo-2,5-dimethoxyphenyl)ethylamine; N-Methyl-3,4-methylenedioxyamphetamine; Psilocybin

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.