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

Cocaine Addiction Clinical Trial

— STUC  

Official title:

A Pilot Study of Deep Brain Stimulation of the Sub-thalamic Nucleus to Treat Treatment-resistant Cocaine Addiction With Severe Somatic or Psychiatric Complications

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02892851
• Other study ID #: P111014
• Status: Recruiting
• Phase: N/A
• First received: August 18, 2016
• Last updated: September 1, 2016
• Start date: March 2014
• Est. completion date: March 2018

Study information

• Verified date: August 2016
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Luc MALLET
• Phone: (0)1 49 81 30 52
• Email: luc.mallet[@]inserm.fr
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2
• Est. completion date: March 2018
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 55 Years

Eligibility

Inclusion Criteria:

• 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

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:

• 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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Behavior, Addictive
• Cocaine Addiction
• Cocaine-Related Disorders

Intervention

Device:
• Deep brain stimulation of the subthalamic nuclei (STN-DBS)
3 phases : Parameter setting Cross-over double-bind (ON/OFF) Open Phase (ON)

Locations

Country	Name	City	State
France	Henri Mondor Hospital	Creteil

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evolution of the Obsessive Compulsive Cocaine Scale (OCCS) craving score		at month 6	No
Secondary	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)	Yes
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	Capillary screening assay for cocaine use		Month -2, Month 4,5 and Month 10 (+1,5)	No
Secondary	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)	No