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Clinical and Genetic Factors Associated With Psychotic Symptoms Among Cocaine Abusers (PSYCHOCOKE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01569347
First Posted: April 3, 2012
Last Update Posted: December 8, 2016
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.
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
  Purpose
The aim of this study is to determine the clinical, genetic and environmental factors associated with the phenotype "severe psychotic symptoms" caused by cocaine.

Condition Intervention
Cocaine-induced Psychotic Disorder During Intoxication Other: Interviews Other: Blood sample Other: Hair sample

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Multicentric Descriptive Cross-sectional Study Evaluating Cocaine Users in Treatment Center

Resource links provided by NLM:


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

Primary Outcome Measures:
  • causes and protective factors of Cocaine Induced Psychosis CIP [ Time Frame: up to one day after taking cocaine ]
    1. clinical data
    2. biologic data
    3. genetic data


Secondary Outcome Measures:
  • gene, environment interactions associated with CIP [ Time Frame: up to one day after taking cocaine ]
    clinical and genetic data


Biospecimen Retention:   Samples With DNA
  • Hair sampling: cocain and metabolit dosage (last 3 months)
  • Blood sampling : plasmatic DBH activity, polymorphisms of several genes (DBH,D2R, DAT, COMT)

Enrollment: 417
Study Start Date: April 2012
Study Completion Date: November 2016
Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1: Cocaine users
Adults, cocaine users
Other: Interviews
Interviews
Other: Blood sample
Blood sample
Other: Hair sample
Hair sample

Detailed Description:
The second purpose is to include gene x environment interaction and to analyse the factors associated with the presence or the absence of severe psychotic symptoms induced by cocaine.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Lifetime cocaine users
Criteria

Inclusion criteria:

  • Adults, cocaine users, who have signed an informed consent

Exclusion criteria:

  • Poor venous condition (for blood samples), specially protected people, non French speaking, people who refuse to sign the consent.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01569347


Locations
France
Espace Murger, Hôpital Fernand Widal
Paris, France, 75010
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Florence VORSPAN, MD, MSC Assistance Publique - Hôpitaux de Paris
  More Information

Publications:
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01569347     History of Changes
Other Study ID Numbers: NI10027 / AOM 10165
2011-A00115-36 ( Other Identifier: Eudra CT )
First Submitted: March 16, 2012
First Posted: April 3, 2012
Last Update Posted: December 8, 2016
Last Verified: December 2016

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Cocaine
Cocaine-induced psychosis
Genetic
Clinical
Biological

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Shared Paranoid Disorder
Schizophrenia Spectrum and Other Psychotic Disorders
Schizophrenia
Cocaine
Anesthetics, Local
Anesthetics
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