Clinical trial NCT01569347: Clinical and Genetic Factors Associated With Psychotic Symptoms Among Cocaine Abusers
Official title: Multicentric Descriptive Cross-sectional Study Evaluating Cocaine Users in Treatment Center
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cocaine-induced Psychotic Disorder During Intoxication
Keywords: Cocaine
Cocaine-induced psychosis
Genetic
Clinical
Biological
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2012-04-03
Enrollment: 417
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Lifetime cocaine users

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.

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 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.

Primary outcomes:
measure: causes and protective factors of Cocaine Induced Psychosis CIP
timeFrame: up to one day after taking cocaine
Secondary outcomes:
measure: gene, environment interactions associated with CIP
timeFrame: up to one day after taking cocaine
Other outcomes:
Locations:
city: Paris
country: France
facility: Espace Murger, Hôpital Fernand Widal
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Florence VORSPAN, MD, MSC
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.