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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00701532 |
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Date of registration:
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18/06/2008 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Brain Imaging Study of the Effects of Modafinil in Cocaine Addiction
CAIMAN |
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Scientific title:
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Dopamine Transporter (DAT) in Pharmacological Treatments of Cocaine Dependence. CAIMAN (Cocaine Addiction Imaging Medications and Neurotransmitters) Study |
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Date of first enrolment:
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April 2009 |
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Target sample size:
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29 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00701532 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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France
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Contacts
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Name:
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Michel Reynaud, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Assistance Publique - Hôpitaux de Paris Hôpital Paul Brousse |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Cocaine Dependence
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Cocaine Addiction
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Intervention(s)
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Drug: placebo
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Drug: Modafinil and PET (brain imaging)
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Primary Outcome(s)
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Decreased DAT occupation rates in the modafinil group versus placebo from day 3 to day of cocaine detoxification.
[Time Frame: day 3 and day of cocaine detoxification]
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Secondary Outcome(s)
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Tolerance and safety evaluation of high modafinil doses, measured by adverse events and biological parameters.
[Time Frame: D3 to D90]
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Evaluation of the clinical efficacy of modafinil during therapeutic cocaine withdrawal.
[Time Frame: D3 to D90]
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Correlation between craving measurements, depressive symptom measurements and cognitive deficit measurements observed and modifications of DAT density.
[Time Frame: D3 to D21]
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Study of DAT from D3 to D21 versus a pre-existing data base of control subjects.
[Time Frame: D3 to D21]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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