Overview

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