NCT00254306

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 16, 2005

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2006

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

July 7, 2011

Status Verified

July 1, 2011

Enrollment Period

5.5 years

First QC Date

November 15, 2005

Last Update Submit

July 6, 2011

Conditions

Amphetamine-Related Disorders

Keywords

EcstasyD2 Dopamine ReceptorIBZMMDMA

Study Arms (2)

1

ex-"ecstasy" users

2

control subjects

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients from treatment centers for drug abuse. Control subjects will be recruited from the general population.

You may qualify if:

  • Chronic users of ecstasy, and healthy controls, with no other diseases or drug abuse

You may not qualify if:

  • Pregnant and breast feeding women
  • Aged below 18
  • Neurological disorders
  • Drug abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Nuclear Medicine, Hadassah Hospital, Ein Kerem

Jerusalem, 91120, Israel

Location

MeSH Terms

Conditions

Amphetamine-Related Disorders

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Yodphat Krausz, MD

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR

  • Aviv M Weinstein, Ph.D

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 15, 2005

First Posted

November 16, 2005

Study Start

January 1, 2006

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

July 7, 2011

Record last verified: 2011-07

Locations

IL(1)