Brain Imaging Study of the Effects of Modafinil in Cocaine Addiction - Full Text View

Sponsor:	Assistance Publique - Hôpitaux de Paris
Collaborator:	Mission Interministérielle de Lutte contre la Drogue et la Toxicomanie
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00701532

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 III

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:

Drug Information available for: Dopamine Cocaine hydrochloride Modafinil

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 ]

Estimated Enrollment:	30
Study Start Date:	April 2009
Estimated Study Completion Date:	July 2011
Estimated Primary Completion Date:	May 2011 (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

Contacts

Contact: Laurent Karila, MD

+33(0)-1 4559 6513

laurent.karila@pbr.aphp.fr

Locations

France
Unité de recherche U797 Inserm - CEA - Université Paris-Sud. " Neuroimagerie & Psychiatrie " Service Hospitalier Frédéric Joliot	Recruiting
Orsay, France, 91401
Contact: Jean-Luc Martinot, MD
Principal Investigator: Jean-Luc Martinot, MD
Centre d'Enseignement, de Recherche et de Traitements des Addictions - Hopital Universitaire Paul Brousse	Recruiting
Villejuif, France, 94800
Contact: Laurent Karila, MD +33 (0)-1 4559 6513 laurent.karila@pbr.aphp.fr
Principal Investigator: Laurent Karila, MD

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:	Mathieu QUINTIN, Department Clinical Research of developpement
ClinicalTrials.gov Identifier:	NCT00701532 History of Changes
Other Study ID Numbers:	P070150
Study First Received:	June 18, 2008
Last Updated:	July 9, 2010
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 February 09, 2012