- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00254306
Functional Brain Imaging in Recreational Users of Ecstasy
Study Overview
Status
Conditions
Detailed Description
Recreational use of "ecstasy" (MDMA; 3, 4-Methylenedioxymethamphetamine) is associated with long-lasting effects on metabolism in the human brain. In particular, there is evidence of long-term damage to the brains' neurotransmitter serotonin (5-HT). It is also known that chronic use of Methamphetamine (which is similar in its chemical structure to "ecstasy") is linked to impaired cognitive and motor skills despite recovery of dopamine transporters (DAT). We have investigated whether chronic use of "ecstasy" is causing any impairment in motor skills and function of the dopaminergic system in recreational users of "ecstasy". In our preliminary study, we have scanned control subjects and "ecstasy" users, at baseline and after performing on a motorbike riding computer game while imaging dopamine in vivo with [123I] IBZM (a D2 receptor radiotracer) in Single Photon Emission Computed Tomography (SPECT). We showed:
- Lower measures of D2 at baseline in ecstasy users compared with control subjects, that means lower level of dopaminergic activity in "ecstasy" users.
- Significant displacement of [123I] IBZM by endogenous dopamine released during the game in healthy subjects unlike "ecstasy" users, that means that recreational users of "ecstasy" release much less natural dopamine.
- No difference between the groups in performance (reaction time) on riding the game after a year of recovery.
Our results show preliminary evidence for dopaminergic deficiency in "ecstasy" users, a finding that has not been shown before. However, similar to other drugs of abuse, it is not known whether dopaminergic deficiency is the cause or consequence of the use of "ecstasy". We now propose to proceed to scan more recreational users of "ecstasy" in order to assess whether chronic use of "ecstasy" is associated with deficient dopaminergic neurotransmission in the brain.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Jerusalem, Israel, 91120
- Dept. of Nuclear Medicine, Hadassah Hospital, Ein Kerem
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Chronic users of ecstasy, and healthy controls, with no other diseases or drug abuse
Exclusion Criteria:
- Pregnant and breast feeding women
- Aged below 18
- Neurological disorders
- Drug abuse
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
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1
ex-"ecstasy" users
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2
control subjects
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yodphat Krausz, MD, Hadassah Medical Organization
- Principal Investigator: Aviv M Weinstein, Ph.D, Hadassah Medical Organization
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 050893-HMO-CTIL
- n/q
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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