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

This study has been completed.
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris Identifier:
First received: March 16, 2012
Last updated: December 7, 2016
Last verified: December 2016
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
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.

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

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
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Please refer to this study by its identifier: NCT01569347

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

Responsible Party: Assistance Publique - Hôpitaux de Paris Identifier: NCT01569347     History of Changes
Other Study ID Numbers: NI10027 / AOM 10165
2011-A00115-36 ( Other Identifier: Eudra CT )
Study First Received: March 16, 2012
Last Updated: December 7, 2016

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

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Shared Paranoid Disorder
Schizophrenia Spectrum and Other Psychotic Disorders
Anesthetics, Local
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 processed this record on September 21, 2017