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

This study has been completed.
Sponsor:
Collaborator:
Mission Interministérielle de Lutte contre la Drogue et la Toxicomanie
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00701532
First received: June 18, 2008
Last updated: April 10, 2013
Last verified: April 2013
History of Changes
  Purpose

-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 Intervention Phase
Cocaine Addiction
Cocaine Dependence
 Drug: Modafinil and PET (brain imaging)
Drug: placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Evaluation of the clinical efficacy of modafinil during therapeutic cocaine withdrawal. [ Time Frame: D3 to D90 ] [ Designated as safety issue: No ]
  • Correlation between craving measurements, depressive symptom measurements and cognitive deficit measurements observed and modifications of DAT density. [ Time Frame: D3 to D21 ] [ Designated as safety issue: No ]
  • Study of DAT from D3 to D21 versus a pre-existing data base of control subjects. [ Time Frame: D3 to D21 ] [ Designated as safety issue: No ]
  • Tolerance and safety evaluation of high modafinil doses, measured by adverse events and biological parameters. [ Time Frame: D3 to D90 ] [ Designated as safety issue: Yes ]

Enrollment: 29
Study Start Date: April 2009
Study Completion Date: January 2013
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
active
 Drug: Modafinil and PET (brain imaging)
duration 90 days
Other Name: Modafinil and PET (brain imaging)
Placebo Comparator: 2
Placebo
 Drug: placebo
duration 90 days
Other Name: placebo

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00701532

Locations
France
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
Investigators
Study Director: Michel Reynaud, PhD Assistance Publique - Hôpitaux de Paris Hôpital Paul Brousse
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00701532     History of Changes
Other Study ID Numbers: P070150
Study First Received: June 18, 2008
Last Updated: April 10, 2013
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Cocaine
Substance abuse
Addiction
 Dependence
Modafinil
Brain imaging

Additional relevant MeSH terms:
Behavior, Addictive
Cocaine-Related Disorders
Compulsive Behavior
Impulsive Behavior
Substance-Related Disorders
Mental Disorders
Cocaine
Modafinil
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Uptake Inhibitors
Dopamine Agents
 Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Central Nervous System Stimulants
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on May 21, 2013