NCT00701532

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2009

Typical duration for phase_3

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 18, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 19, 2008

Completed
10 months until next milestone

Study Start

First participant enrolled

April 1, 2009

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

April 11, 2013

Status Verified

April 1, 2013

Enrollment Period

3.5 years

First QC Date

June 18, 2008

Last Update Submit

April 10, 2013

Conditions

Cocaine AddictionCocaine Dependence

Keywords

CocaineSubstance abuseAddictionDependenceModafinilBrain imaging

Outcome Measures

Primary Outcomes (1)

  • Decreased DAT occupation rates in the modafinil group versus placebo from day 3 to day of cocaine detoxification.

    day 3 and day of cocaine detoxification

Secondary Outcomes (4)

  • Evaluation of the clinical efficacy of modafinil during therapeutic cocaine withdrawal.

    D3 to D90

  • Correlation between craving measurements, depressive symptom measurements and cognitive deficit measurements observed and modifications of DAT density.

    D3 to D21

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

    D3 to D21

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

    D3 to D90

Study Arms (2)

1

EXPERIMENTAL

active

Drug: Modafinil and PET (brain imaging)

2

PLACEBO COMPARATOR

Placebo

Drug: placebo

Interventions

Modafinil and PET (brain imaging)DRUG

duration 90 days

1
placeboDRUG

duration 90 days

2

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unité de recherche U797 Inserm - CEA - Université Paris-Sud. " Neuroimagerie & Psychiatrie " Service Hospitalier Frédéric Joliot

Orsay, 91401, France

Location

Centre d'Enseignement, de Recherche et de Traitements des Addictions - Hopital Universitaire Paul Brousse

Villejuif, 94800, France

Location

MeSH Terms

Conditions

Cocaine-Related DisordersSubstance-Related DisordersBehavior, Addictive

Interventions

Modafinil2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazoleNeuroimaging

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersCompulsive BehaviorImpulsive BehaviorBehavior

Intervention Hierarchy (Ancestors)

Benzhydryl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, NeurologicalInvestigative Techniques

Study Officials

  • Michel Reynaud, PhD

    Assistance Publique - Hôpitaux de Paris Hôpital Paul Brousse

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2008

First Posted

June 19, 2008

Study Start

April 1, 2009

Primary Completion

October 1, 2012

Study Completion

January 1, 2013

Last Updated

April 11, 2013

Record last verified: 2013-04

Locations

FR(2)