Functional Brain Imaging in Recreational Users of Ecstasy

NCT ID: NCT00254306

Last Updated: 2011-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

18 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-01-31

Study Completion Date

2011-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Amphetamine-Related Disorders

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

ex-"ecstasy" users

No interventions assigned to this group

2

control subjects

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hadassah Medical Organization

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Hadassah Medical Organization

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yodphat Krausz, MD

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Organization

Aviv M Weinstein, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Organization

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Dept. of Nuclear Medicine, Hadassah Hospital, Ein Kerem

Jerusalem, , Israel

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Israel

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

n/q

Identifier Type: -

Identifier Source: secondary_id

050893-HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.