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

April 10, 2013 updated by: Assistance Publique - Hôpitaux de Paris

Dopamine Transporter (DAT) in Pharmacological Treatments of Cocaine Dependence. CAIMAN (Cocaine Addiction Imaging Medications and Neurotransmitters) Study

-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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Context:

Cocaine dependence is a disorder with a rapidly progressive evolution, associated with various complications. Because of cocaine's direct action on the dopamine transporter (DAT), dopaminergic system dysregulation plays a fundamental role in reinforcement phenomenon and in dependence. This has been proven in numerous animal and post-death human studies of striatal DAT. In vivo studies in cocaine dependent patients are rare. Currently no pharmacotherapy is available to treat this pathology. Current studies indicate that pharmacological agents such as modafinil may be able to reverse the neuroadaptations induced by cocaine dependence. However, no functional neuroimaging study (Positron Emission Tomography, PET) has analysed the impact of medications on DAT density in cocaine dependent patients. However, in primates, in vivo PET has shown modafinil affinity for DAT.

Primary Hypothesis:

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

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.

Secondary:

Evaluation of the clinical efficacy of modafinil during therapeutic cocaine withdrawal. Correlation between craving measurements, depressive symptom measurements and cognitive deficit measurements observed and modifications of DAT density.

Study of DAT from D3 to D21 versus a pre-existing data base of control subjects.

Tolerance and safety evaluation of high modafinil doses, measured by adverse events and biological parameters.

Calculation of the number of subjects: A power of 90% is found for a number of subjects estimated at 24 (bilateral test, α risk at 5%, estimated SEM of 5%, variation of the occupational concentration of the DAT expected to be at least 12% in the modafinil group). Considering the usual rate of patients lost to follow-up in this patient population (25%), we plan to include 30 patients.

Methodology: This study is regulated by the law on biomedical research of August 9, 2004. It is a randomised monocentric double blind study versus placebo. During the study, for 90 days, patients will receive in double blind either modafinil or placebo according to their randomisation arm.

Evaluations will include 2 PET, cerebral MRI, blood work-up, urinary toxin screen, clinical scales for craving, depression and neuropsychological evaluations.

Patients will be recruited over 24 months. The total study length will be 36 months.

Primary judgment criteria: Variation of the linking potentials (specific fixation rate for the radioligand [11C]-PE2I to DAT) between the TEP measurement on D3 and D21 within the various anatomical region of interest between the 2 groups (modafinil, placebo).

Expected Results: Decreased DAT occupation rates in the modafinil group versus placebo from D3 to D21 of withdrawal.

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Orsay, France, 91401
        • Unité de recherche U797 Inserm - CEA - Université Paris-Sud. " Neuroimagerie & Psychiatrie " Service Hospitalier Frédéric Joliot
      • Villejuif, France, 94800
        • Centre d'Enseignement, de Recherche et de Traitements des Addictions - Hopital Universitaire Paul Brousse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
Placebo
Drug: placebo
duration 90 days
Experimental: 1
active
Drug: Modafinil and PET (brain imaging)
duration 90 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
day 3 and day of cocaine detoxification

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Mission Interministérielle de Lutte contre la Drogue et la Toxicomanie

Investigators

  • Study Director: Michel Reynaud, PhD, Assistance Publique - Hôpitaux de Paris Hôpital Paul Brousse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

June 18, 2008

First Submitted That Met QC Criteria

June 18, 2008

First Posted (Estimate)

June 19, 2008

Study Record Updates

Last Update Posted (Estimate)

April 11, 2013

Last Update Submitted That Met QC Criteria

April 10, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P070150

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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