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

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.

Study Overview

• Status: Unknown
• Conditions: Cocaine Addiction
• Intervention / Treatment: Device: Deep brain stimulation of the subthalamic nuclei (STN-DBS)

• Study Type: Interventional
• Enrollment (Anticipated): 2
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Luc MALLET; Phone Number: +33 (0)1 49 81 30 52; Email: luc.mallet@inserm.fr
• Study Contact Backup: Name: Florence VORSPAN; Phone Number: +33 (0) 1 40 05 44 17; Email: florence.vorspan@aphp.fr

Study Locations

• France
  • Creteil, France, 94010
    • Recruiting
    • Henri Mondor Hospital
    • Contact: Philippe DOMENECH; Phone Number: +33 (0) 1 49 81 22 03; Email: philippe.domenech@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 55 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Deep brain stimulation (DBS); Deep brain stimulation of the subthalamic nuclei (STN-DBS)	Device: Deep brain stimulation of the subthalamic nuclei (STN-DBS); 3 phases : Parameter setting; Cross-over double-bind (ON/OFF); Open Phase (ON); Other Names: Activa PC Medtronic (7428) stimulator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evolution of the Obsessive Compulsive Cocaine Scale (OCCS) craving score	at month 6

Secondary Outcome Measures

Outcome Measure	Time Frame
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)
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)
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)
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)
Capillary screening assay for cocaine use	Month -2, Month 4,5 and Month 10 (+1,5)
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)

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Anticipated): September 1, 2017
• Study Completion (Anticipated): March 1, 2018

Study Registration Dates

• First Submitted: August 18, 2016
• First Submitted That Met QC Criteria: September 1, 2016
• First Posted (Estimate): September 8, 2016

Study Record Updates

• Last Update Posted (Estimate): September 8, 2016
• Last Update Submitted That Met QC Criteria: September 1, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Craving; STN-DBS; Cocaine addiction
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Compulsive Behavior; Impulsive Behavior; Behavior, Addictive; Cocaine-Related Disorders
• Other Study ID Numbers: P111014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO