NCT05488171

Abuse Potential and Human Pharmacology of Methylone

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Germans Trias i Pujol Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purposes of the study are 1) To assess the abuse potential of methylone after controlled administration of a single oral dose of methylone 2) to evaluate subjective and physiological effects of methylone 3) to determine the pharmacokinetics parameters and metabolism of methylone.

Detailed description

Methylone is a synthetic cathinone that has been popularized as an alternative to other illegal psychostimulants as methylenedioxymethamphetamine (MDMA, ecstasy) or mephedrone. Chemically, methylone is a beta-keto analogue of ecstasy with similar pharmacological effects in animals. To date, the available data about the human pharmacology of methylone in humans is very scarce and is mainly provided by users' experience published in internet forums or intoxication reports. A pilot study was carried out to select the methylone dose used in this study. This current study is aimed 1) To assess the abuse potential of methylone after controlled administration of a single oral dose of methylone 2) to evaluate subjective and physiological effects of methylone 3) to determine the pharmacokinetics parameters and metabolism of methylone.

Conditions

• Substance Use
• Healthy Subjects

Interventions

Type	Name	Description
DRUG	Methylone	Single oral dose of 200 mg of methylone.
DRUG	3,4-methylenedioxymethamphetamine	Single oral dose of 100 mg of MDMA.
DRUG	Placebo	Single oral dose of placebo.

Timeline

• Start date: 2021-12-01
• Primary completion: 2022-07-31
• Completion: 2022-09-30
• First posted: 2022-08-04
• Last updated: 2022-08-08

Locations

1 site across 1 country: Spain