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
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Drug: 3,4-methylenedioxymethamphetamine
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Drug: Methylphenidate
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Drug: Placebo
Condition or Disease
- Healthy
Phase
Study Design
Study type: | Interventional |
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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 | |
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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
Location
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 |
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Minimum Age: | 18 |
Maximum Age: | 45 |
More Details
NCT Number: | NCT01465685 |
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Other IDs: | EK 228/11 |
Study URL: | https://ClinicalTrials.gov/show/NCT01465685 |
Last updated: Jun 17, 2022