NCT01569347

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
417

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 16, 2012

Completed
16 days until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 3, 2012

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

December 8, 2016

Status Verified

December 1, 2016

Enrollment Period

4.6 years

First QC Date

March 16, 2012

Last Update Submit

December 7, 2016

Conditions

Cocaine-induced Psychotic Disorder During Intoxication

Keywords

CocaineCocaine-induced psychosisGeneticClinicalBiological

Outcome Measures

Primary Outcomes (1)

  • causes and protective factors of Cocaine Induced Psychosis CIP

    1. clinical data 2. biologic data 3. genetic data

    up to one day after taking cocaine

Secondary Outcomes (1)

  • gene, environment interactions associated with CIP

    up to one day after taking cocaine

Study Arms (1)

1: Cocaine users

Adults, cocaine users

Other: InterviewsOther: Blood sampleOther: Hair sample

Interventions

InterviewsOTHER

Interviews

1: Cocaine users
Blood sampleOTHER

Blood sample

1: Cocaine users
Hair sampleOTHER

Hair sample

1: Cocaine users

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Lifetime cocaine users

You may qualify if:

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

You may not qualify if:

  • Poor venous condition (for blood samples), specially protected people, non French speaking, people who refuse to sign the consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Espace Murger, Hôpital Fernand Widal

Paris, 75010, France

Location

Related Publications (5)

  • Vorspan F, Fortias M, Zerdazi el-H, Karsinti E, Bloch V, Lepine JP, Bellivier F, Brousse G, van den Brink W, Derks EM. Self-reported cue-induced physical symptoms of craving as an indicator of cocaine dependence. Am J Addict. 2015 Dec;24(8):740-3. doi: 10.1111/ajad.12303. Epub 2015 Nov 6.

    PMID: 26541796RESULT

  • Karsinti E, Jarroir M, Zerdazi el-H, Bloch V, Dupuy G, Belforte B, Coeuru P, Plat A, Deschenau A, Cottencin O, Gay A, Lack P, Pelissier-Alicot AL, Bellivier F, Lepine JP, Brousse G, Vorspan F. Childhood trauma are not associated with the intensity of transient cocaine induced psychotic symptoms. Psychiatry Res. 2015 Aug 30;228(3):941-4. doi: 10.1016/j.psychres.2015.05.065. Epub 2015 Jun 27.

    PMID: 26154812RESULT

  • Vorspan F, Brousse G, Bloch V, Bellais L, Romo L, Guillem E, Coeuru P, Lepine JP. Cocaine-induced psychotic symptoms in French cocaine addicts. Psychiatry Res. 2012 Dec 30;200(2-3):1074-6. doi: 10.1016/j.psychres.2012.04.008. Epub 2012 May 1.

    PMID: 22551940RESULT

  • Brousse G, Vorspan F, Ksouda K, Bloch V, Peoc'h K, Laplanche JL, Mouly S, Schmidt J, Llorca PM, Lepine JP. Could the inter-individual variability in cocaine-induced psychotic effects influence the development of cocaine addiction? Towards a new pharmacogenetic approach to addictions. Med Hypotheses. 2010 Dec;75(6):600-4. doi: 10.1016/j.mehy.2010.07.043.

    PMID: 20801583RESULT

  • Icick R, Vorspan F, Karsinti E, Ksouda K, Lepine JP, Brousse G, Mouly S, Bellivier F, Bloch V. Gender-specific study of recurrent suicide attempts in outpatients with multiple substance use disorders. J Affect Disord. 2018 Dec 1;241:546-553. doi: 10.1016/j.jad.2018.08.076. Epub 2018 Aug 13.

    PMID: 30153638DERIVED

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)

MeSH Terms

Interventions

Interviews as TopicBlood Specimen Collection

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthSpecimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, Operative

Study Officials

  • Florence VORSPAN, MD, MSC

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2012

First Posted

April 3, 2012

Study Start

April 1, 2012

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

December 8, 2016

Record last verified: 2016-12

Locations

FR(1)