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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2014 by Assistance Publique - Hôpitaux de Paris
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris Identifier:
First received: March 16, 2012
Last updated: December 13, 2014
Last verified: December 2014
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 ] [ 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: November 2016
Estimated 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
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01569347

Contact: Florence VORSPAN, MD, MSC 33 1 40 05 42 75

Espace Murger, Hôpital Fernand Widal Recruiting
Paris, France, 75010
Contact: Florence VORSPAN, MD, MSC    +33 1 40 05 42 75   
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 
Study First Received: March 16, 2012
Last Updated: December 13, 2014
Health Authority: France: Ministry of Health

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
Dopamine Agents
Dopamine Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sensory System Agents
Vasoconstrictor Agents processed this record on May 26, 2016