Emotional Effects of Methylphenidate and MDMA in Healthy Subjects

Brief Summary

This study compares the interactive emotional/subjective effects of single doses of 3,4-methylenedioxymethamphetamine (MDMA, "ecstasy") and methylphenidate, a dopamine (DA) and norepinephrine (NE) transporter blocker, in healthy subjects. The primary goal is to determine the role of transporter mediated DA and NE release in the subjective response to MDMA in humans. The investigators hypothesize that methylphenidate will attenuate the subjective response to MDMA.

Intervention / Treatment

  • Drug: 3,4-methylenedioxymethamphetamine
  • Drug: Methylphenidate
  • Drug: Placebo

Condition or Disease

  • Healthy

Phase

Study Design

Study type: Interventional
Status: Completed
Study results: No Results Available
Age: 18 Years to 45 Years   (Adult)
Enrollment: 16 ()
Funded by: Other

Masking

Clinical Trial Dates

Start date: Dec 01, 2011
Primary Completion: Dec 01, 2012
Completion Date: Jan 01, 2013
Study First Posted: Nov 06, 2011
Results First Posted: Aug 30, 2020
Last Updated: Jan 21, 2016

Sponsors / Collaborators

Lead Sponsor: N/A
Responsible Party: N/A

3,4-methylenedioxymethamphetamine (MDMA, "ecstasy") is widely used by young people for its euphoric effects. MDMA releases serotonin (5-HT), dopamine (DA), and norepinephrine (NE). 5-HT release mainly contributes to the subjective effects of MDMA whereas NE release is involved in the cardiovascular and psychostimulant effects of MDMA. DA is also likely to be involved in the rewarding and reinforcing effects of drugs of abuse. However, the functional role of DA in the subjective effects of MDMA in humans is largely unclear. To determine the role of the DA transporter (DAT) in the response to MDMA in humans the investigators test the effects of the DA and NE transporter blocker methylphenidate on the subjective effects of MDMA. The investigators use a randomized double-blind placebo-controlled cross-over design with four experimental sessions. methylphenidate or placebo will be administered before MDMA or placebo to 16 healthy volunteers. Subjective and cardiovascular responses will be repeatedly assessed throughout the experiments and plasma samples are collected for pharmacokinetics. The primary hypothesis is that methylphenidate will significantly reduce the subjective effects of MDMA.

Eligibility Criteria

Sex: All
Minimum Age: 18
Maximum Age: 45

More Details

NCT Number: NCT01465685
Other IDs: EK 228/11
Study URL: https://ClinicalTrials.gov/show/NCT01465685
Last updated: Jun 17, 2022