Cocaine AddictionSTUCNCT02892851
Deep Brain Stimulation of the Sub-Thalamic Nucleus to Treat Severe and Treatment-resistant Cocaine Addiction.
A study testing Deep brain stimulation of the subthalamic nuclei (STN-DBS) in people with Cocaine Addiction, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 30 to 55 years
- Conditions the study is for
- Cocaine Addiction
- What is being tested?
- Deep brain stimulation of the subthalamic nuclei (STN-DBS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2014to Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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,
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- 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.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Henri Mondor Hospital
Créteil, 94010
Philippe DOMENECH, (0) 1 49 81 22 03 ext. +33, philippe.domenech@aphp.fr
About this study
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.
- Conditions
- Cocaine Addiction
- Being tested
- Deep brain stimulation of the subthalamic nuclei (STN-DBS)
- Keywords
- STN-DBS, Craving, Cocaine addiction
- Medical subject headings
- Cocaine-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep brain stimulation of the subthalamic nuclei (STN-DBS)Device
Also called Activa PC Medtronic (7428) stimulator
3 phases :
- Parameter setting
- Cross-over double-bind (ON/OFF)
- Open Phase (ON)
| Study group | Role | What they receive |
|---|---|---|
| Deep brain stimulation (DBS) | Experimental | Deep brain stimulation of the subthalamic nuclei (STN-DBS) Receives: Device: Deep brain stimulation of the subthalamic nuclei (STN-DBS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of the Obsessive Compulsive Cocaine Scale (OCCS) craving score
Measured: at month 6
Secondary outcomes (6)
Psychiatric assessment by standardized interview
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Month -2, Month 4,5 and Month 10 (+1,5)
Evolution of Global Assessment of Functioning scale (GAF)
Measured: Month -2, Month 2, Month 3, Month 3+15 days, Month 4+15days, Month 6, Month 7, Month 8, Month 9, Month10 (+1,5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2016 (estimated)
- Study startMar 2014
- Primary completionSep 2017 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cocaine AddictionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02892851
- Sponsor's protocol ID
- P111014
- Acronym
- STUC
- Status last verified
- Aug 2016
- First submitted
- 18 Aug 2016
- Last updated
- 8 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02892851
- Acronym / sponsor ID
- STUC / P111014
- Conditions
- Cocaine Addiction
- Keywords
- STN-DBS, Craving, Cocaine addiction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 8 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Deep brain stimulation (DBS) | Experimental | Device: Deep brain stimulation of the subthalamic nuclei (STN-DBS)Deep brain stimulation of the subthalamic nuclei (STN-DBS) |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- severe and resistant Cocaine Dependence for 5 years defined as:
- 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
Key exclusion criteria (11 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deep brain stimulation of the subthalamic nuclei (STN-DBS)Also: Activa PC Medtronic (7428) stimulator3 phases : * Parameter setting * Cross-over double-bind (ON/OFF) * Open Phase (ON) | Device | Deep brain stimulation (DBS) |
Primary outcome
Evolution of the Obsessive Compulsive Cocaine Scale (OCCS) craving score
Time frame: at month 6
6 secondary outcomes
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep brain stimulation of the subthalamic nuclei (STN-DBS) in people with Cocaine Addiction, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luc MALLET ((0)1 49 81 30 52 ext. +33, luc.mallet@inserm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of the Obsessive Compulsive Cocaine Scale (OCCS) craving score (time frame: at month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2016.