Treatment Methamphetamine AddictionNCT03347474
Deep Brain Stimulation of Nucleus Accumbens for Methamphetamine Addiction
A study testing Bilateral surgical implantation of DBS system to NAc in people with Treatment Methamphetamine Addiction, run by Ruijin Hospital at 1 site in China.
Trial summary
The main objective of this study is to assess the efficacy of bilateral deep brain stimulation (DBS) of the Nucleus Accumbens(NAc) as a novel treatment in severe methamphetamine addiction. Our hypothesis is that bilateral DBS of the NAc will significantly reduce the craving for methamphetamine. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Treatment Methamphetamine Addiction
- What is being tested?
- Bilateral surgical implantation of DBS system to NAc
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 20 Sep 2017to 30 Dec 2020
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- DSM-IV-TR diagnosis of Drug addiction disorder;
- Age 18-65 years old;
- Proficiency in Mandarin language;
- Failure to detox more than three times;
- Capacity to provide informed consent (understanding of the study purpose and methods);
Who cannot join
- Multidrug abuse and formation of addiction;
- Serious and unstable organic diseases (e.g. unstable coronal heart disease);
- Any history of seizure disorder or hemorrhagic stroke;
- Past stereotactic neurosurgical intervention;
- Neurological disease (Abnormal PET-CT, MRI, EEG)
- Contraindications of MRI-examination, e.g. implanted cardiac pacemaker/ heart defibrillator;
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- Contraindications of stereotactic intervention, e.g. increased bleeding disposition, cerebrovascular diseases (e.g. arteriovenous malfunction, aneurysms, systemic vascular diseases);
- HIV positive;
- Pregnancy and/or lactation;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Ruijin Hospital Functional Neurosurgery
Shanghai, Shanghai Municipality, 200025
Chencheng Zhang, MD, +086-18217122884, i@cczhang.org
Yingying Zhang, MSc, +086-17602137369, zhyy019@126.com
About this study
The main objective of this study is to assess the efficacy of bilateral deep brain stimulation (DBS) of the Nucleus Accumbens(NAc) as a novel treatment in severe methamphetamine addiction. Our hypothesis is that bilateral DBS of the NAc will significantly reduce the craving for methamphetamine.
- Conditions
- Treatment Methamphetamine Addiction
- Being tested
- Bilateral surgical implantation of DBS system to NAc
- Keywords
- Bilateral Nucleus Accumbens, Methamphetamine Addiction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral surgical implantation of DBS system to NAcProcedure or surgery
The Medtronic, PINS and SceneRay DBS device will be utilized in the present study.
| Study group | Role | What they receive |
|---|---|---|
| Bilateral surgical implantation of DBS system to NAc | Experimental | Not described Receives: Procedure: Bilateral surgical implantation of DBS system to NAc |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in 10-point visual analog scale of carving
The score of scale is from 0 to 10. 0 represents no carving for drug, 10 means the greatest degree of carving for drug.
Measured: Baseline (preoperative),3 months,6 months, 12 months
change in Obsessive Compulsive Drug Use Scale
Measured: Baseline (preoperative),3 months,6 months, 12 months
Secondary outcomes (8)
Side Effect
Measured: Baseline（preoperative）,3 months, 6 months, 12months
Change in the Hamilton Anxiety Scale
Measured: Baseline（preoperative）,3 months, 6 months, 12months
Change in the Hamilton Depression Scale
Measured: Baseline（preoperative）,3 months, 6 months, 12 months
Change in the Quality of Life Assessment (SF-36)
Measured: Baseline（preoperative）,3 months, 6 months, 12 months
Change in World Health Organization Quality of Life-BREF(WHO-BREF)
Measured: Baseline（preoperative）,3 months,6 months, 12 months
Chang in Pittsburgh Sleep Quality Index
Measured: Baseline（preoperative）,3 months,6 months, 12 months
Neuropsychological measures(Scores of cognitive battery)
Measured: Baseline（preoperative）,6 months,12 months
Change in Fagerstrom Test of Nicotine Dependence(FTND)
Measured: Baseline（preoperative）,3 months,6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2017
- Study start20 Sep 2017
- Primary completion20 Sep 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Treatment Methamphetamine AddictionStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe 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
- Model description
- All subjects will receive bilateral surgical implantation of DBS system
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bomin Sun, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03347474
- Sponsor's protocol ID
- 2018-10-25 DBS-NAc Meth
- Status last verified
- Oct 2018
- First submitted
- 3 Sep 2017
- Last updated
- 26 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kuhn J, Moller M, Treppmann JF, Bartsch C, Lenartz D, Gruendler TO, Maarouf M, Brosig A, Barnikol UB, Klosterkotter J, Sturm V. Deep brain stimulation of the nucleus accumbens and its usefulness in severe opioid addiction. Mol Psychiatry. 2014 Feb;19(2):145-6. doi: 10.1038/mp.2012.196. Epub 2013 Jan 22. No abstract available.
PubMed 23337942
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Brain Stimulation of Nucleus Accumbens for Methamphetamine Addiction
- ClinicalTrials.gov ID
- NCT03347474
- Acronym / sponsor ID
- 2018-10-25 DBS-NAc Meth
- Conditions
- Treatment Methamphetamine Addiction
- Keywords
- Bilateral Nucleus Accumbens, Methamphetamine Addiction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 20 Sep 2017 (actual)
- Primary completion
- 20 Sep 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 20 Nov 2017 (actual)
- 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.
The main objective of this study is to assess the efficacy of bilateral deep brain stimulation (DBS) of the Nucleus Accumbens(NAc) as a novel treatment in severe methamphetamine addiction. Our hypothesis is that bilateral DBS of the NAc will significantly reduce the craving for methamphetamine.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All subjects will receive bilateral surgical implantation of DBS system
| Arm | Type | Receives |
|---|---|---|
| Bilateral surgical implantation of DBS system to NAc | Experimental | Procedure: Bilateral surgical implantation of DBS system to NAc |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- DSM-IV-TR diagnosis of Drug addiction disorder;
- Age 18-65 years old;
- Proficiency in Mandarin language;
- Failure to detox more than three times;
- Capacity to provide informed consent (understanding of the study purpose and methods);
Key exclusion criteria (9 listed)
- Multidrug abuse and formation of addiction;
- Serious and unstable organic diseases (e.g. unstable coronal heart disease);
- Any history of seizure disorder or hemorrhagic stroke;
- Past stereotactic neurosurgical intervention;
- Neurological disease (Abnormal PET-CT, MRI, EEG)
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 |
|---|---|---|
| Bilateral surgical implantation of DBS system to NAcThe Medtronic, PINS and SceneRay DBS device will be utilized in the present study. | Procedure or surgery | Bilateral surgical implantation of DBS system to NAc |
Primary outcome
change in 10-point visual analog scale of carving
Time frame: Baseline (preoperative),3 months,6 months, 12 months
The score of scale is from 0 to 10. 0 represents no carving for drug, 10 means the greatest degree of carving for drug.
change in Obsessive Compulsive Drug Use Scale
Time frame: Baseline (preoperative),3 months,6 months, 12 months
8 secondary outcomes
Side Effect
Time frame: Baseline（preoperative）,3 months, 6 months, 12months
Change in the Hamilton Anxiety Scale
Time frame: Baseline（preoperative）,3 months, 6 months, 12months
Change in the Hamilton Depression Scale
Time frame: Baseline（preoperative）,3 months, 6 months, 12 months
Change in the Quality of Life Assessment (SF-36)
Time frame: Baseline（preoperative）,3 months, 6 months, 12 months
Change in World Health Organization Quality of Life-BREF(WHO-BREF)
Time frame: Baseline（preoperative）,3 months,6 months, 12 months
Chang in Pittsburgh Sleep Quality Index
Time frame: Baseline（preoperative）,3 months,6 months, 12 months
Neuropsychological measures(Scores of cognitive battery)
Time frame: Baseline（preoperative）,6 months,12 months
Change in Fagerstrom Test of Nicotine Dependence(FTND)
Time frame: Baseline（preoperative）,3 months,6 months, 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2018.
- Background: PubMed 23337942Kuhn J, Moller M, Treppmann JF, Bartsch C, Lenartz D, Gruendler TO, Maarouf M, Brosig A, Barnikol UB, Klosterkotter J, Sturm V. Deep brain stimulation of the nucleus accumbens and its usefulness in severe opioid addiction. Mol Psychiatry. 2014 Feb;19(2):145-6. doi: 10.1038/mp.2012.196. Epub 2013 Jan 22. No abstract available.
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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 Bilateral surgical implantation of DBS system to NAc in people with Treatment Methamphetamine Addiction, run by Ruijin Hospital at 1 site in China.
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 5 inclusion and 9 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 26 Oct 2018. 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 China. 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 Chencheng Zhang, MD (+086-18217122884, i@cczhang.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in 10-point visual analog scale of carving (time frame: Baseline (preoperative),3 months,6 months, 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03347474, which also lists 1 linked publication.
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 26 Oct 2018.