Brain Imaging Study of the Effects of Modafinil in Cocaine Addiction (CAIMAN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00701532
Recruitment Status : Completed
First Posted : June 19, 2008
Last Update Posted : April 11, 2013
Mission Interministérielle de Lutte contre la Drogue et la Toxicomanie
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.

Primary Hypothesis:

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

Condition or disease Intervention/treatment Phase
Cocaine Addiction Cocaine Dependence Drug: Modafinil and PET (brain imaging) Drug: placebo Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dopamine Transporter (DAT) in Pharmacological Treatments of Cocaine Dependence. CAIMAN (Cocaine Addiction Imaging Medications and Neurotransmitters) Study
Study Start Date : April 2009
Actual Primary Completion Date : October 2012
Actual Study Completion Date : January 2013

Arm Intervention/treatment
Experimental: 1
Drug: Modafinil and PET (brain imaging)
duration 90 days

Placebo Comparator: 2
Drug: placebo
duration 90 days

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Evaluation of the clinical efficacy of modafinil during therapeutic cocaine withdrawal. [ Time Frame: D3 to D90 ]
  2. Correlation between craving measurements, depressive symptom measurements and cognitive deficit measurements observed and modifications of DAT density. [ Time Frame: D3 to D21 ]
  3. Study of DAT from D3 to D21 versus a pre-existing data base of control subjects. [ Time Frame: D3 to D21 ]
  4. Tolerance and safety evaluation of high modafinil doses, measured by adverse events and biological parameters. [ Time Frame: D3 to D90 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00701532

Unité de recherche U797 Inserm - CEA - Université Paris-Sud. " Neuroimagerie & Psychiatrie " Service Hospitalier Frédéric Joliot
Orsay, France, 91401
Centre d'Enseignement, de Recherche et de Traitements des Addictions - Hopital Universitaire Paul Brousse
Villejuif, France, 94800
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Mission Interministérielle de Lutte contre la Drogue et la Toxicomanie
Study Director: Michel Reynaud, PhD Assistance Publique - Hôpitaux de Paris Hôpital Paul Brousse

Responsible Party: Assistance Publique - Hôpitaux de Paris Identifier: NCT00701532     History of Changes
Other Study ID Numbers: P070150
First Posted: June 19, 2008    Key Record Dates
Last Update Posted: April 11, 2013
Last Verified: April 2013

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Substance abuse
Brain imaging

Additional relevant MeSH terms:
Behavior, Addictive
Cocaine-Related Disorders
Compulsive Behavior
Impulsive Behavior
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Wakefulness-Promoting Agents
Central Nervous System Stimulants
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers