Brain Imaging Study of the Effects of Modafinil in Cocaine Addiction

• Status: Completed
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: Male

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.

Primary Hypothesis:

More rapid normalisation of DAT concentrations measured by PET using modafinil versus placebo from D3 to D21 during cocaine detoxification.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborator: Mission Interministérielle de Lutte contre la Drogue et la Toxicomanie
• Treatments: Armodafinil; Cocaine; Modafinil

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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