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Brain Imaging Study of the Effects of Modafinil in Cocaine Addiction

NCT00701532 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2013-04-11

No results posted yet for this study

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.

Conditions

  • Cocaine Addiction
  • Cocaine Dependence

Interventions

DRUG

Modafinil and PET (brain imaging)

duration 90 days

DRUG

placebo

duration 90 days

Sponsors & Collaborators

  • Mission Interministérielle de Lutte contre la Drogue et la Toxicomanie

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Michel Reynaud, PhD · Assistance Publique - Hôpitaux de Paris Hôpital Paul Brousse

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2012-10-31
Completion
2013-01-31

Countries

  • France

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00701532 on ClinicalTrials.gov