Dependence, CocaineCRACK-ANTNCT01025219
A Contribution to the Analysis of the Phenotypic Heterogeneity in Crack/Cocaine Addiction : a Case Control Study
A study testing Collect 10 ml of Saliva for DNA extraction in people with Dependence, Cocaine, run by University Hospital Center of Martinique at 1 site in France.
Trial summary
The purpose of this study is to assess the phenotypic candidates symptoms, in patients with crack/cocaine addiction, in terms of clinical comorbidities, dimensions of personality, and neuropsychological evaluations apt to be associated with genetic and genotypic characterisations, notably on the polymorphisms of the… Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Dependence, Cocaine
- What is being tested?
- Collect 10 ml of Saliva for DNA extraction
- How many people
- 600 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2009to Dec 2012
- Phase
- Interventional
- 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 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis of cocaine abuse/dependence according to DSM-IV-TR criteria
- Come from French West Indies (3 grandparents are African-Caribbean)
- Sign a written informed consent
- Platelets donor
- No substance abuse/dependence according to DSM-IV-TR criteria
- Come from French West Indies (3 grandparents are African-Caribbean)
- Sign a written informed consent
Who cannot join
- Minor
- Men with no cocaine abuse/dependence according to DSM-IV-TR criteria
- For the control:
- Minor
- Men refusing a genetic study
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service de psychiatrie et addictologie - CHU de Fort-de-France
Fort-de-France, Martinique, 97261
Jocelyne CRASPAG, Master, 596 59 26 98 ext. +596, jocelyne.craspag@chu-fortdefrance.fr
Mickaëlle ROSE, Master, 596 59 26 98 ext. +596, mickaelle.rose@chu-fortdefrance.fr
About this study
Official title: A Case Control Study on Contribution to the Analysis of the Phenotypic Heterogeneity in Crack/Cocaine Addiction
The purpose of this study is to assess the phenotypic candidates symptoms, in patients with crack/cocaine addiction, in terms of clinical comorbidities, dimensions of personality, and neuropsychological evaluations apt to be associated with genetic and genotypic characterisations, notably on the polymorphisms of the genes coding or regulating dopaminergic, norepinephrine and serotoninergic systems.
Read the detailed description
Genetic studies show an association between drug addiction and the dopaminergic system and its modulators. Nonetheless, results are contradictory, partially due to the heterogeneity of the phenotype addiction. Placed on the trafficking route of cocaine, and homogeneously populated, Martinique is of particular interest for the study of the vulnerability of the crack/cocaine addiction. In a precedent study, supported by a grant MILDT / INSERM 2000, on 155 men dependent to crack/cocaine and characterised with three clinical dimensions -sensation seeking, impulsivity and childhood ADHD- we found an association between each dimension and polymorphisms of DRD2 and DRD4 genes.
- Conditions
- Dependence, Cocaine
- Being tested
- Collect 10 ml of Saliva for DNA extraction
- Keywords
- Diagnosis of dependence on cocaine according to DSM-IV-TR criteria
- Medical subject headings
- Cocaine-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collect 10 ml of Saliva for DNA extractionGenetic
After signed written informed consent, all patients and controls have clinical and neuropsychological evaluations (DIGS, WURS, BROWN, BIS, SSS and IGT) for phenotypic diagnosis and collection of saliva for DNA extraction and genotyping diagnosis.
What is being measured
The primary outcome is the main question the study is designed to answer.
The specific measure that will be related to core objectives of the study is to constitute a sample collection from saliva.
Measured: The saliva will be collect at the end of the first visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dependence, CocaineStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Center of Martinique
- Sponsor type
- University, hospital or other
- Investigators
- Jérôme LACOSTE, MD, Principal investigator, CHU de Fort-de-France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01025219
- Sponsor's protocol ID
- 09/B/01
- Acronym
- CRACK-ANT
- Status last verified
- Mar 2011
- First submitted
- 1 Dec 2009
- Last updated
- 22 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Case Control Study on Contribution to the Analysis of the Phenotypic Heterogeneity in Crack/Cocaine Addiction
- ClinicalTrials.gov ID
- NCT01025219
- Acronym / sponsor ID
- CRACK-ANT / 09/B/01
- Conditions
- Dependence, Cocaine
- Keywords
- Diagnosis of dependence on cocaine according to DSM-IV-TR criteria
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University Hospital Center of MartiniqueUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 3 Dec 2009 (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 purpose of this study is to assess the phenotypic candidates symptoms, in patients with crack/cocaine addiction, in terms of clinical comorbidities, dimensions of personality, and neuropsychological evaluations apt to be associated with genetic and genotypic characterisations, notably on the polymorphisms of the genes coding or regulating dopaminergic, norepinephrine and serotoninergic systems.
Detailed description
Genetic studies show an association between drug addiction and the dopaminergic system and its modulators. Nonetheless, results are contradictory, partially due to the heterogeneity of the phenotype addiction. Placed on the trafficking route of cocaine, and homogeneously populated, Martinique is of particular interest for the study of the vulnerability of the crack/cocaine addiction. In a precedent study, supported by a grant MILDT / INSERM 2000, on 155 men dependent to crack/cocaine and characterised with three clinical dimensions -sensation seeking, impulsivity and childhood ADHD- we found an association between each dimension and polymorphisms of DRD2 and DRD4 genes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of cocaine abuse/dependence according to DSM-IV-TR criteria
- Come from French West Indies (3 grandparents are African-Caribbean)
- Sign a written informed consent
- Platelets donor
- No substance abuse/dependence according to DSM-IV-TR criteria
Key exclusion criteria (5 listed)
- Minor
- Men with no cocaine abuse/dependence according to DSM-IV-TR criteria
- Minor
- Men refusing a genetic study
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 |
|---|---|---|
| Collect 10 ml of Saliva for DNA extractionAfter signed written informed consent, all patients and controls have clinical and neuropsychological evaluations (DIGS, WURS, BROWN, BIS, SSS and IGT) for phenotypic diagnosis and collection of saliva for DNA extraction and genotyping diagnosis. | Genetic | – |
Primary outcome
The specific measure that will be related to core objectives of the study is to constitute a sample collection from saliva.
Time frame: The saliva will be collect at the end of the first visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2011.
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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.
Jérôme LACOSTE, MD principal investigator
CHU de Fort-de-France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collect 10 ml of Saliva for DNA extraction in people with Dependence, Cocaine, run by University Hospital Center of Martinique 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 7 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 22 Mar 2011. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jérôme LACOSTE, MD (596 55 20 44 ext. +596, jerome.lacoste@chu-fortdefrance.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The specific measure that will be related to core objectives of the study is to constitute a sample collection from saliva. (time frame: The saliva will be collect at the end of the first visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Mar 2011.