Deep Brain Stimulation of the Sub-Thalamic Nucleus to Treat Severe and Treatment-resistant Cocaine Addiction.

NCT02892851 | Unknown DMC

• 1 other identifier: P111014
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cocaine Addiction

Keywords

STN-DBS; Craving; Cocaine addiction

Outcome Measures

Primary Outcomes (1)

• Evolution of the Obsessive Compulsive Cocaine Scale (OCCS) craving score

  at month 6

Secondary Outcomes (6)

• 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)

• 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)

Study Arms (1)

Deep brain stimulation (DBS)

EXPERIMENTAL

Deep brain stimulation of the subthalamic nuclei (STN-DBS)

Device: Deep brain stimulation of the subthalamic nuclei (STN-DBS)

Interventions

Deep brain stimulation of the subthalamic nuclei (STN-DBS) DEVICE

3 phases : * Parameter setting * Cross-over double-bind (ON/OFF) * Open Phase (ON)

Also known as: Activa PC Medtronic (7428) stimulator

Deep brain stimulation (DBS)

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• severe and resistant Cocaine Dependence for 5 years defined as:
• cocaine dependence (DSM IV),
• preferential use of cocaine in base form (crack or free-base) through smoke,
• non response to at least two well-conducted treatment with at least a stay in aftercare,
• severe physical complications (defined as a history of myocardial infarction, stroke).
• 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

You may not qualify if:

• 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:
• current or past dependence to nicotine,
• abuse or dependence on other psychoactive substances over a lifetime in remission for more than 6 months,
• current opioid dependence: if the patient is undergoing substitution treatment (methadone or buprenorphine) and not injection of opiates for at least 6 months,
• when other psychiatric disorders induced by substances.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Henri Mondor Hospital

Créteil, 94010, France

RECRUITING

MeSH Terms

Conditions

Cocaine-Related Disorders

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Central Study Contacts

Luc MALLET

CONTACT

(0)1 49 81 30 52; luc.mallet@inserm.fr

Florence VORSPAN

CONTACT

(0) 1 40 05 44 17; florence.vorspan@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2016
• First Posted: September 8, 2016
• Study Start: March 1, 2014
• Primary Completion: September 1, 2017
• Study Completion: March 1, 2018
• Last Updated: September 8, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)