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Cocaine addiction is a chronic condition with severe cardiac, neurologic, psychiatric and social complications. Cocaine is the second most consumed illicit drug in France. Its prevalence has been multiplied by 3 between 2000 and 2008, and is still on the rise. Craving, the compulsive need to consume, is a key feature of cocaine addiction. It is also predictive of treatment efficacy. However, there is no validated treatment for severe cocaine dependence yet. Response to current psychological and medical treatment is poor, with 73% relapse after 3 months. Patients with severe cocaine addiction are thus in a therapeutic deadlock.
To address these unmet medical needs, the investigators designed a pilot study (n=2) to evaluate the safety and the efficacy of the deep brain stimulation of the subthalamic nuclei (STN-DBS) in severe cocaine addiction with at least one cardiac, neurologic or psychiatric complication. Indeed, compulsivity is a critical component of craving, and severe treatment-resistant obsessive compulsive disorder (OCD) are already successfully treated using STN-DBS. Moreover, animal studies recently demonstrated a therapeutic effect of STN-DBS in rats addicted to cocaine. Together, these two lines of research suggest a therapeutic effect of STN-DBS in cocaine addiction mediated by an anti-obsessive mechanism on craving.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Deep brain stimulation (DBS) | Experimental | Deep brain stimulation of the subthalamic nuclei (STN-DBS) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deep brain stimulation of the subthalamic nuclei (STN-DBS) | Device | 3 phases :
|
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| Measure | Description | Time Frame |
|---|---|---|
| Evolution of the Obsessive Compulsive Cocaine Scale (OCCS) craving score | at month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Psychiatric assessment by standardized interview | Month -2, Month 2, Month 3, Month 3+15 days, Month 4+15days, Month 6, Month 7, Month 8, Month 9, Month10 (+1,5) | |
| Cocaine Craving Questionnaire (CCQ) craving score | Month -2, Month 2 (1day), Month 2 (2nd day), Month 2 (3rd day), Month 3, Month 3+15 days, Month 4+15days, Month 6, Month 7, Month 8, Month 9, Month 10 (+1,5) |
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Inclusion Criteria:
severe and resistant Cocaine Dependence for 5 years defined as:
psychotic syndromes induced recurrent, severe lung disease "crack-lungs") occurred due to crack consumption and whose association with the crack use is known to the patient
age between 30 and 55 years
patient affiliated to a social security scheme
patient signed an informed consent after receiving written information on the proposed procedure
Exclusion Criteria:
a current opioid dependence will not be a criterion of non inclusion if the patient is undergoing substitution treatment (methadone or buprenorphine) and not injection of opiates for at least six months.
patient trust
pregnant, nursing or of childbearing potential without effective contraception
current use of the intravenous route for the administration of the drugs is the risk of infection
VIH infection or VHC unstabilized,
cardiovascular and / or brain state is not compatible with the surgery,
other disorder on Axis I not linked to cocaine use except:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luc MALLET | Contact | (0)1 49 81 30 52 | +33 | luc.mallet@inserm.fr |
| Florence VORSPAN | Contact | (0) 1 40 05 44 17 | +33 | florence.vorspan@aphp.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henri Mondor Hospital | Recruiting | Créteil | 94010 | France |
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| ID | Term |
|---|---|
| D019970 | Cocaine-Related Disorders |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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|
| Self assessed addiction criteria | Month -2, Month 2, Month 3, Month 3+15 days, Month 4+15days, Month 6, Month 7, Month 8, Month 9, Month10 (+1,5) |
| Urine screening assay for cocaine use / Urine Drug Screening | Month -2, Month 2, Month 3, Month 3+15 days, Month 4+15days, Month 6, Month 7, Month 8, Month 9, Month10 (+1,5) |
| Capillary screening assay for cocaine use | Month -2, Month 4,5 and Month 10 (+1,5) |
| Evolution of Global Assessment of Functioning scale (GAF) | Month -2, Month 2, Month 3, Month 3+15 days, Month 4+15days, Month 6, Month 7, Month 8, Month 9, Month10 (+1,5) |