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

December 7, 2016 updated by: Assistance Publique - Hôpitaux de Paris

Multicentric Descriptive Cross-sectional Study Evaluating Cocaine Users in Treatment Center

The aim of this study is to determine the clinical, genetic and environmental factors associated with the phenotype "severe psychotic symptoms" caused by cocaine.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

417

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75010
        • Espace Murger, Hôpital Fernand Widal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Lifetime cocaine users

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1: Cocaine users
Adults, cocaine users
Other: Blood sample
Blood sample
Other: Interviews
Interviews
Other: Hair sample
Hair sample

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to one day after taking cocaine

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
gene, environment interactions associated with CIP
Time Frame: up to one day after taking cocaine
clinical and genetic data
up to one day after taking cocaine

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Florence VORSPAN, MD, MSC, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

March 16, 2012

First Submitted That Met QC Criteria

March 30, 2012

First Posted (Estimate)

April 3, 2012

Study Record Updates

Last Update Posted (Estimate)

December 8, 2016

Last Update Submitted That Met QC Criteria

December 7, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NI10027 / AOM 10165
  • 2011-A00115-36 (Other Identifier: Eudra CT)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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