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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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.


Detailed Summary:
Sponsor: Assistance Publique - Hôpitaux de Paris

Current Primary Outcome: Evolution of the Obsessive Compulsive Cocaine Scale (OCCS) craving score [ Time Frame: at month 6 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Psychiatric assessment by standardized interview [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Month -2, Month 4,5 and Month 10 (+1,5) ]
  • Evolution of Global Assessment of Functioning scale (GAF) [ Time Frame: Month -2, Month 2, Month 3, Month 3+15 days, Month 4+15days, Month 6, Month 7, Month 8, Month 9, Month10 (+1,5) ]


Original Secondary Outcome: Same as current

Information By: Assistance Publique - Hôpitaux de Paris

Dates:
Date Received: August 18, 2016
Date Started: March 2014
Date Completion: March 2018
Last Updated: September 1, 2016
Last Verified: August 2016