search
Back to results

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

Primary Purpose

Cocaine Addiction

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Deep brain stimulation of the subthalamic nuclei (STN-DBS)
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cocaine Addiction focused on measuring STN-DBS, Craving, Cocaine addiction

Eligibility Criteria

30 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Henri Mondor HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Deep brain stimulation (DBS)

Arm Description

Deep brain stimulation of the subthalamic nuclei (STN-DBS)

Outcomes

Primary Outcome Measures

Evolution of the Obsessive Compulsive Cocaine Scale (OCCS) craving score

Secondary Outcome Measures

Psychiatric assessment by standardized interview
Cocaine Craving Questionnaire (CCQ) craving score
Self assessed addiction criteria
Urine screening assay for cocaine use / Urine Drug Screening
Capillary screening assay for cocaine use
Evolution of Global Assessment of Functioning scale (GAF)

Full Information

First Posted
August 18, 2016
Last Updated
September 1, 2016
Sponsor
Assistance Publique - Hôpitaux de Paris
search

1. Study Identification

Unique Protocol Identification Number
NCT02892851
Brief Title
Deep Brain Stimulation of the Sub-Thalamic Nucleus to Treat Severe and Treatment-resistant Cocaine Addiction.
Acronym
STUC
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2014 (undefined)
Primary Completion Date
September 2017 (Anticipated)
Study Completion Date
March 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine Addiction
Keywords
STN-DBS, Craving, Cocaine addiction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Deep brain stimulation (DBS)
Arm Type
Experimental
Arm Description
Deep brain stimulation of the subthalamic nuclei (STN-DBS)
Intervention Type
Device
Intervention Name(s)
Deep brain stimulation of the subthalamic nuclei (STN-DBS)
Other Intervention Name(s)
Activa PC Medtronic (7428) stimulator
Intervention Description
3 phases : Parameter setting Cross-over double-bind (ON/OFF) Open Phase (ON)
Primary Outcome Measure Information:
Title
Evolution of the Obsessive Compulsive Cocaine Scale (OCCS) craving score
Time Frame
at month 6
Secondary Outcome Measure Information:
Title
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)
Title
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)
Title
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)
Title
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)
Title
Capillary screening assay for cocaine use
Time Frame
Month -2, Month 4,5 and Month 10 (+1,5)
Title
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luc MALLET
Phone
(0)1 49 81 30 52
Ext
+33
Email
luc.mallet@inserm.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Florence VORSPAN
Phone
(0) 1 40 05 44 17
Ext
+33
Email
florence.vorspan@aphp.fr
Facility Information:
Facility Name
Henri Mondor Hospital
City
Creteil
ZIP/Postal Code
94010
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe DOMENECH
Phone
(0) 1 49 81 22 03
Ext
+33
Email
philippe.domenech@aphp.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs