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Functional Brain Imaging in Recreational Users of Ecstasy

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ClinicalTrials.gov Identifier: NCT00254306
Recruitment Status : Completed
First Posted : November 16, 2005
Last Update Posted : July 7, 2011
Sponsor:
Information provided by:
Hadassah Medical Organization

Tracking Information
First Submitted Date November 15, 2005
First Posted Date November 16, 2005
Last Update Posted Date July 7, 2011
Study Start Date January 2006
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Functional Brain Imaging in Recreational Users of Ecstasy
Official Title Functional Brain Imaging in Recreational Users of Ecstasy
Brief Summary Recreational use of "ecstasy" (MDMA; 3,4-methylenedioxymethamphetamine) is associated with long-lasting effects on metabolism in the human brain. The investigators propose to investigate whether chronic use of "ecstasy" is associated with impairment in motor skills and function of the dopaminergic system in recreational users of "ecstasy" compared with healthy volunteers. This will be done by scanning control subjects and "ecstasy" users at baseline and after performing on a motorbike riding computer game, while imaging dopamine in vivo with I123-IBZM (a D2 receptor radiotracer), using single photon emission computed tomography (SPECT).
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:

  1. Lower measures of D2 at baseline in ecstasy users compared with control subjects, that means lower level of dopaminergic activity in "ecstasy" users.
  2. 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.
  3. 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 Observational
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients from treatment centers for drug abuse. Control subjects will be recruited from the general population.
Condition Amphetamine-Related Disorders
Intervention Not Provided
Study Groups/Cohorts
  • 1
    ex-"ecstasy" users
  • 2
    control subjects
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 6, 2011)
18
Original Enrollment
 (submitted: November 15, 2005)
10
Actual Study Completion Date July 2011
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Israel
Removed Location Countries  
 
Administrative Information
NCT Number NCT00254306
Other Study ID Numbers 050893-HMO-CTIL
n/q
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Dr. Aviv Weinstein, Hadassah Medical Organization
Study Sponsor Hadassah Medical Organization
Collaborators Not Provided
Investigators
Principal Investigator: Yodphat Krausz, MD Hadassah Medical Organization
Principal Investigator: Aviv M Weinstein, Ph.D Hadassah Medical Organization
PRS Account Hadassah Medical Organization
Verification Date July 2011