Clinical Trials Logo

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.


Clinical Trial Description

n/a


Study Design

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


Related Conditions & MeSH terms


NCT number NCT02892851
Study type Interventional
Source Assistance Publique - Hôpitaux de Paris
Contact Luc MALLET
Phone (0)1 49 81 30 52
Email luc.mallet@inserm.fr
Status Recruiting
Phase N/A
Start date March 2014
Completion date March 2018

See also
  Status Clinical Trial Phase
Completed NCT02563769 - Clavulanic Acid (CLAV) and Cocaine Interaction Safety Study Phase 1
Completed NCT02939352 - The Effects of Theta Burst Stimulation on the Brain Response to Drug and Alcohol Cues Early Phase 1
Active, not recruiting NCT01822587 - Enhancing Disrupted Reconsolidation: Impact on Cocaine Craving Phase 2
Completed NCT01601743 - Exercise as a Behavioral Treatment for Cocaine Dependence N/A
Not yet recruiting NCT03423667 - Efficacy of N-acetylcysteine on the Craving Symptoms of Abstinent Hospitalized Patients With Cocaine Addiction Phase 2
Completed NCT01651377 - Pramipexole as a Treatment for Cocaine Dependence Phase 1
Completed NCT02768441 - Dexamphetamine Sustained Release Pharmacokinetics and Clinical Validation of Dried Blood Spots Early Phase 1
Completed NCT02626494 - Neurobiological Adaptations and Pharmacological Interventions in Cocaine Addiction Phase 4
Not yet recruiting NCT01319214 - Reducing Drug Craving Memories N/A
Recruiting NCT01259362 - Effects of Repeated Transcranial Magnetic Stimulation (rTMS) on the Treatment of Cocaine Addicted Patients Phase 2
Recruiting NCT01211418 - Integrative Meditation (IM) for Cocaine Addiction N/A
Completed NCT01887366 - Efficacy and Safety of TV-1380 as Treatment for Facilitation of Abstinence in Cocaine-Dependent Subjects Phase 2
Completed NCT01984177 - Effects of Corticorelin Administration on Dopamine Transmission, Craving, and Mood in Cocaine Dependence N/A
Completed NCT01337297 - Prefrontal Cortex Stimulation as Treatment for Crack-cocaine Addiction Phase 1/Phase 2
Completed NCT01067846 - Cognitive Enhancement and Relapse Prevention in Cocaine Addiction N/A
Completed NCT01651364 - A Pilot Study of Cabergoline for the Treatment of Cocaine Dependence Phase 1
Recruiting NCT03018236 - Effect of N-acetylcysteine on Alcohol and Cocaine Use Disorders: A Double-Blind Randomized Controlled Trial. Phase 4
Not yet recruiting NCT03025321 - Effects of Repetitive tDCS on Relapse in Cocaine Addiction: EMA Study N/A
Recruiting NCT01929343 - Lidocaine Infusion as a Treatment for Cocaine Relapse and Craving Phase 2
Completed NCT01281202 - Vigabatrin for the Treatment of Cocaine Dependency Phase 2/Phase 3