Cocaine Addiction Clinical Trial
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
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.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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