NCT02892851

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 30 Years – 55 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	Deep brain stimulation of the subthalamic nuclei (STN-DBS)	3 phases : * Parameter setting * Cross-over double-bind (ON/OFF) * Open Phase (ON)

Timeline

• Start date: 2014-03-01
• Primary completion: 2017-09-01
• Completion: 2018-03-01
• First posted: 2016-09-08
• Last updated: 2016-09-08

Locations

1 site across 1 country: France