Clinical and Genetic Factors Associated With Psychotic Symptoms Among Cocaine Abusers

Cocaine-induced Psychotic Disorder During Intoxication Clinical Trial

— PSYCHOCOKE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01569347
• Other study ID #: NI10027 / AOM 10165
• Secondary ID: 2011-A00115-36
• Status: Completed
• Phase: N/A
• First received: March 16, 2012
• Last updated: December 7, 2016
• Start date: April 2012
• Est. completion date: November 2016

Study information

• Verified date: December 2016
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 417
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Cocaine-induced Psychotic Disorder During Intoxication
• Mental Disorders
• Psychotic Disorders

Intervention

Other:
• Interviews
Interviews
• Blood sample
Blood sample
• Hair sample
Hair sample

Locations

Country	Name	City	State
France	Espace Murger, Hôpital Fernand Widal	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (4)

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 pharmacoge — View 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, Lépine JP, Brousse G, Vorspan F. Childhood trauma are not associated with the intensity of tran — View Citation

Vorspan F, Brousse G, Bloch V, Bellais L, Romo L, Guillem E, Coeuru P, Lépine 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. — View Citation

Vorspan F, Fortias M, Zerdazi el-H, Karsinti E, Bloch V, Lépine 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	causes and protective factors of Cocaine Induced Psychosis CIP	clinical data; biologic data; genetic data	up to one day after taking cocaine	No
Secondary	gene, environment interactions associated with CIP	clinical and genetic data	up to one day after taking cocaine	No