Cocaine-induced Psychotic Disorder During IntoxicationPSYCHOCOKENCT01569347
Clinical and Genetic Factors Associated With Psychotic Symptoms Among Cocaine Abusers
An observational study of Cocaine-induced Psychotic Disorder During Intoxication, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cocaine-induced Psychotic Disorder During Intoxication
- What is being tested?
- Interviews, Blood sample and Hair sample
- How many people
- 417 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2012to Nov 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Lifetime cocaine users
Who may be able to join
- Adults, cocaine users, who have signed an informed consent
Who cannot join
- Poor venous condition (for blood samples), specially protected people, non French speaking, people who refuse to sign the consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Interviews, Blood sample, Hair sample
- Keywords
- Cocaine, Cocaine-induced psychosis, Genetic, Clinical, Biological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewsOther
Interviews
Blood sampleOther
Blood sample
Hair sampleOther
Hair sample
| Study group | Role | What they receive |
|---|---|---|
| 1: Cocaine users | Adults, cocaine users Receives: Other: Interviews; Other: Blood sample; Other: Hair sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
causes and protective factors of Cocaine Induced Psychosis CIP
- clinical data
- biologic data
- genetic data
Measured: up to one day after taking cocaine
Secondary outcomes (1)
gene, environment interactions associated with CIP
clinical and genetic data
Measured: up to one day after taking cocaine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cocaine-induced Psychotic Disorder During IntoxicationStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 417 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florence VORSPAN, MD, MSC, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01569347
- Sponsor's protocol ID
- NI10027 / AOM 10165
- Other IDs
- 2011-A00115-36
- Acronym
- PSYCHOCOKE
- Status last verified
- Dec 2016
- First submitted
- 16 Mar 2012
- Last updated
- 8 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26541796Karsinti 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.
PubMed 26154812Vorspan 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.
PubMed 22551940Brousse 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.
PubMed 20801583Icick 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.
PubMed 30153638
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric Descriptive Cross-sectional Study Evaluating Cocaine Users in Treatment Center
- ClinicalTrials.gov ID
- NCT01569347
- Acronym / sponsor ID
- PSYCHOCOKE / NI10027 / AOM 10165
- Keywords
- Cocaine, Cocaine-induced psychosis, Genetic, Clinical, Biological
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 417 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 3 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1: Cocaine users | – | Other: Interviews, Other: Blood sample, Other: Hair sampleAdults, cocaine users |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Lifetime cocaine users
Key inclusion criteria (1 listed)
- Adults, cocaine users, who have signed an informed consent
Key exclusion criteria (1 listed)
- Poor venous condition (for blood samples), specially protected people, non French speaking, people who refuse to sign the consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterviewsInterviews | Other | 1: Cocaine users |
| Blood sampleBlood sample | Other | 1: Cocaine users |
| Hair sampleHair sample | Other | 1: Cocaine users |
Primary outcome
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
1 secondary outcome
gene, environment interactions associated with CIP
Time frame: up to one day after taking cocaine
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2016.
- Results publication: PubMed 26541796Vorspan 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.
- Results publication: PubMed 26154812Karsinti 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.
- Results publication: PubMed 22551940Vorspan 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.
- Results publication: PubMed 20801583Brousse 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.
- Derived from this study: PubMed 30153638Icick 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Florence VORSPAN, MD, MSC principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cocaine-induced Psychotic Disorder During Intoxication, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
causes and protective factors of Cocaine Induced Psychosis CIP (time frame: up to one day after taking cocaine). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01569347, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2016.