Status:
COMPLETED
Brain Imaging Study of the Effects of Modafinil in Cocaine Addiction
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Mission Interministérielle de Lutte contre la Drogue et la Toxicomanie
Conditions:
Cocaine Addiction
Cocaine Dependence
Eligibility:
MALE
18-65 years
Phase:
PHASE3
Brief Summary
-Context: Study objectives Primary: impact of modafinil versus placebo on DAT density modifications in the striatal and extra-striatal regions in cocaine dependent subjects hospitalised from D3 to D21...
Detailed Description
Context: Cocaine dependence is a disorder with a rapidly progressive evolution, associated with various complications. Because of cocaine's direct action on the dopamine transporter (DAT), dopaminerg...
Eligibility Criteria
Inclusion
- Men of at least 18 years of age
- Cocaine dependent according to DSM IV TR criteria
- Seeking treatment
- Capable of understanding and giving their informed written consent
- With National Health coverage
- Urinary screen positive for cocaine in the weeks prior to inclusion
Exclusion
- Women
- Other DSM IV TR axe I diagnostic criteria (except for tobacco)
- Neurological disorders
- Treatment that interferes with the DAT and modafinil
- Contraindications for modafinil and Magnetic Resonance Imaging
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00701532
Start Date
April 1 2009
End Date
January 1 2013
Last Update
April 11 2013
Active Locations (2)
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1
Unité de recherche U797 Inserm - CEA - Université Paris-Sud. " Neuroimagerie & Psychiatrie " Service Hospitalier Frédéric Joliot
Orsay, France, 91401
2
Centre d'Enseignement, de Recherche et de Traitements des Addictions - Hopital Universitaire Paul Brousse
Villejuif, France, 94800