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

This study is currently recruiting participants.
Verified June 2012 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01569347
First received: March 16, 2012
Last updated: June 14, 2012
Last verified: June 2012
History of Changes
  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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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)

Estimated Enrollment: 400
Study Start Date: April 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01569347

Contacts
Contact: Florence VORSPAN, MD, MSC 33 1 40 05 42 75 florence.vorspan@lrb.aphp.fr

Locations
France
Espace Murger, Hôpital Fernand Widal Recruiting
Paris, France, 75010
Contact: Florence VORSPAN, MD, MSC     +33 1 40 05 42 75     florence.vorspan@lrb.aphp.fr    
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Florence VORSPAN, MD, MSC Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01569347     History of Changes
Other Study ID Numbers: NI10027 / AOM 10165, 2011-A00115-36
Study First Received: March 16, 2012
Last Updated: June 14, 2012
Health Authority: France: Ministry of Health

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

Additional relevant MeSH terms:
Psychotic Disorders
Mental Disorders
Shared Paranoid Disorder
Schizophrenia and Disorders with Psychotic Features
Schizophrenia
Cocaine
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

ClinicalTrials.gov processed this record on May 19, 2013