Opiate AddictionPhase 2/3NCT02440152
The Effectiveness of Deep Brain Stimulation for Opioid Relapse Prevention
A Phase 2/3 study testing Suzhou Sceneray® DBS System in people with Opiate Addiction, run by Ruijin Hospital at 2 sites in China.
Trial summary
The nucleus accumbens (NAcc) has a significant role in the process of opiate addiction and the initiation of relapse after detoxification. There is evidence that deep brain stimulation (DBS) of the NAcc exerts a positive effect on individuals with severe heroin addiction via inhibitory action . Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Opiate Addiction
- What is being tested?
- Suzhou Sceneray® DBS System
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 2 sitesChina
- Study dates
- 1 Feb 2017to Jul 2021
- Phase
- Phase 2/3
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Proficiency in Mandarin language
- Long lasting heroin addiction (determined by diagnostic-criteria in Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition)
- Duration longer than 6 months
- A lack of response to long-term treatment
- Capacity to provide informed consent (understanding of the study purpose and methods)
- Substitution methadone treatment at a constant dose within three months prior to inclusion.
Who cannot join
- Clinical relevant psychiatric comorbidity (schizophrenic psychoses, bipolar affective diseases with psychotic symptoms)(MINI 6.0)
- Past stereotactic neurosurgical intervention
- Neurological disease (Abnormal PET-CT, MRI, EEG)
- Contraindications of MRI-examination, e.g. implanted cardiac pacemaker/ heart defibrillator
- Contraindications of stereotactic intervention, e.g. increased bleeding-disposition, cerebrovascular diseases (e.g. arteriovenous malfunction, aneurysms, systemic vascular diseases)
- Serious and unstable organic diseases (e.g. unstable coronal heart disease)
- HIV positive
- Pregnancy and/or lactation
Trial locations and contacts
2 sites in 1 country.
ChenCheng Zhang, MD contact
Kristina Zeljic, MSc contact
China2 sites, 2 recruiting
- Recruiting
Shanghai RuiJin Hospital Psychitric Department
Shanghai, Shanghai Municipality, 200025
Haiyan Jin, MD, hyjin603@163.com
- Recruiting
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
Jiang Du, MD, dujiangdou@163.com
Min Zhao, MD,PhD, drzhaomin@sh163.net
About this study
The nucleus accumbens (NAcc) has a significant role in the process of opiate addiction and the initiation of relapse after detoxification. There is evidence that deep brain stimulation (DBS) of the NAcc exerts a positive effect on individuals with severe heroin addiction via inhibitory action .
The investigators hypothesise that bilateral stimulation of the NAcc will significantly reduce withdrawal symptoms and thus enable the patients to substantially decrease their Levomethadone usage.
- Conditions
- Opiate Addiction
- Being tested
- Suzhou Sceneray® DBS System
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suzhou Sceneray® DBS SystemDevice
We plan to use the SceneRay 1242 (SceneRay, SuZhou, China) electrode with a diameter of 1.27 mm and 4 contacts. The SceneRay 1242 electrode combined with the SceneRay 1181 implantable pulse generator has the advantage of adaptive coverage area for the Ventral Capsule/Ventral Striatum, enabling simultaneous implantation in the nucleus accumbens (NAc; 2 ventral contacts) and the anterior limb of the internal capsule (ALIC; 2 dorsal contacts) with independently programmed parameters such as frequency, amplitude, and voltage; and remote and wireless programing, which allows for convenient and prompt adjustments in emergency situations. The contact length is 3.0 mm and the spacings between the ventral and dorsal contacts are 2 mm, 4 mm, and 4 mm, respectively, spanning a total length of 22.5 mm (3 + 2 + 3 + 4 + 3 + 4 + 3 mm, with 0.5 mm projecting from the electrode tip).
| Study group | Role | What they receive |
|---|---|---|
| Deep brain stimulation | Experimental | Not described Receives: Device: Suzhou Sceneray® DBS System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weekly urine tests
Measured: Baseline (preoperative), 3 months, 6 months, 9 months, 12 months, 18 months, 24 months
Secondary outcomes (5)
Change in 10-point visual analog scale (VAS) craving score for opioid drugs
Measured: Baseline (preoperative), 3 months, 6 months, 9 months, 12 months, 18 months, 24 months
Change in Hamilton Anxiety Scale
Measured: Baseline (preoperative), 3 months, 6 months, 9 months, 12 months, 18 months, 24 months
Change in Hamilton Depression Scale-17
Measured: Baseline (preoperative), 3 months, 6 months, 9 months, 12 months, 18 months, 24 months
Change in SF-36 assessment
Measured: Baseline (preoperative), 6 months, 12 month, 24 month
Neuropsychological measures（Scores of Iowa gambling task and Model task）
Measured: Baseline (preoperative), Intraoperative,6 months,12month,24month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study start1 Feb 2017
- Primary completionJul 2019 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Opiate 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 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Suzhou Sceneray Medical Co. , Ltd, Shanghai Mental Health Center, Institution of Neuroscience, National Natural Science Foundation of China
- Responsible party
- Principal investigator, Bomin Sun, Ruijin Hospital
- Investigators
- Bomin Sun, MD, PhD, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02440152
- Sponsor's protocol ID
- 2014-15
- Status last verified
- Jun 2017
- First submitted
- 29 Mar 2015
- Last updated
- 29 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Luigjes J, van den Brink W, Feenstra M, van den Munckhof P, Schuurman PR, Schippers R, Mazaheri A, De Vries TJ, Denys D. Deep brain stimulation in addiction: a review of potential brain targets. Mol Psychiatry. 2012 Jun;17(6):572-83. doi: 10.1038/mp.2011.114. Epub 2011 Sep 20.
PubMed 21931318Kuhn 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 23337942Valencia-Alfonso CE, Luigjes J, Smolders R, Cohen MX, Levar N, Mazaheri A, van den Munckhof P, Schuurman PR, van den Brink W, Denys D. Effective deep brain stimulation in heroin addiction: a case report with complementary intracranial electroencephalogram. Biol Psychiatry. 2012 Apr 15;71(8):e35-7. doi: 10.1016/j.biopsych.2011.12.013. Epub 2012 Jan 26. No abstract available.
PubMed 22281120Zhou H, Xu J, Jiang J. Deep brain stimulation of nucleus accumbens on heroin-seeking behaviors: a case report. Biol Psychiatry. 2011 Jun 1;69(11):e41-2. doi: 10.1016/j.biopsych.2011.02.012. Epub 2011 Apr 13. No abstract available.
PubMed 21489407
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Deep Brain Stimulation for Opioid Relapse Prevention
- ClinicalTrials.gov ID
- NCT02440152
- Acronym / sponsor ID
- 2014-15
- Conditions
- Opiate Addiction
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Collaborators
- Suzhou Sceneray Medical Co. , Ltd, Shanghai Mental Health Center, Institution of Neuroscience, National Natural Science Foundation of China
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 12 May 2015 (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.
The nucleus accumbens (NAcc) has a significant role in the process of opiate addiction and the initiation of relapse after detoxification. There is evidence that deep brain stimulation (DBS) of the NAcc exerts a positive effect on individuals with severe heroin addiction via inhibitory action .
The investigators hypothesise that bilateral stimulation of the NAcc will significantly reduce withdrawal symptoms and thus enable the patients to substantially decrease their Levomethadone usage.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Deep brain stimulation | Experimental | Device: Suzhou Sceneray® DBS System |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Proficiency in Mandarin language
- Long lasting heroin addiction (determined by diagnostic-criteria in Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition)
- Duration longer than 6 months
- A lack of response to long-term treatment
- Capacity to provide informed consent (understanding of the study purpose and methods)
Key exclusion criteria (8 listed)
- Clinical relevant psychiatric comorbidity (schizophrenic psychoses, bipolar affective diseases with psychotic symptoms)(MINI 6.0)
- Past stereotactic neurosurgical intervention
- Neurological disease (Abnormal PET-CT, MRI, EEG)
- Contraindications of MRI-examination, e.g. implanted cardiac pacemaker/ heart defibrillator
- Contraindications of stereotactic intervention, e.g. increased bleeding-disposition, cerebrovascular diseases (e.g. arteriovenous malfunction, aneurysms, systemic vascular diseases)
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 |
|---|---|---|
| Suzhou Sceneray® DBS SystemWe plan to use the SceneRay 1242 (SceneRay, SuZhou, China) electrode with a diameter of 1.27 mm and 4 contacts. The SceneRay 1242 electrode combined with the SceneRay 1181 implantable pulse generator has the advantage of adaptive coverage area for the Ventral Capsule/Ventral Striatum, enabling simultaneous implantation in the nucleus accumbens (NAc; 2 ventral contacts) and the anterior limb of the internal capsule (ALIC; 2 dorsal contacts) with independently programmed parameters such as frequency, amplitude, and voltage; and remote and wireless programing, which allows for convenient and prompt adjustments in emergency situations. The contact length is 3.0 mm and the spacings between the ventral and dorsal contacts are 2 mm, 4 mm, and 4 mm, respectively, spanning a total length of 22.5 mm (3 + 2 + 3 + 4 + 3 + 4 + 3 mm, with 0.5 mm projecting from the electrode tip). | Device | Deep brain stimulation |
Primary outcome
Weekly urine tests
Time frame: Baseline (preoperative), 3 months, 6 months, 9 months, 12 months, 18 months, 24 months
5 secondary outcomes
Change in 10-point visual analog scale (VAS) craving score for opioid drugs
Time frame: Baseline (preoperative), 3 months, 6 months, 9 months, 12 months, 18 months, 24 months
Change in Hamilton Anxiety Scale
Time frame: Baseline (preoperative), 3 months, 6 months, 9 months, 12 months, 18 months, 24 months
Change in Hamilton Depression Scale-17
Time frame: Baseline (preoperative), 3 months, 6 months, 9 months, 12 months, 18 months, 24 months
Change in SF-36 assessment
Time frame: Baseline (preoperative), 6 months, 12 month, 24 month
Neuropsychological measures（Scores of Iowa gambling task and Model task）
Time frame: Baseline (preoperative), Intraoperative,6 months,12month,24month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2017.
- Background: PubMed 21931318Luigjes J, van den Brink W, Feenstra M, van den Munckhof P, Schuurman PR, Schippers R, Mazaheri A, De Vries TJ, Denys D. Deep brain stimulation in addiction: a review of potential brain targets. Mol Psychiatry. 2012 Jun;17(6):572-83. doi: 10.1038/mp.2011.114. Epub 2011 Sep 20.
- Results publication: 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.
- Results publication: PubMed 22281120Valencia-Alfonso CE, Luigjes J, Smolders R, Cohen MX, Levar N, Mazaheri A, van den Munckhof P, Schuurman PR, van den Brink W, Denys D. Effective deep brain stimulation in heroin addiction: a case report with complementary intracranial electroencephalogram. Biol Psychiatry. 2012 Apr 15;71(8):e35-7. doi: 10.1016/j.biopsych.2011.12.013. Epub 2012 Jan 26. No abstract available.
- Results publication: PubMed 21489407Zhou H, Xu J, Jiang J. Deep brain stimulation of nucleus accumbens on heroin-seeking behaviors: a case report. Biol Psychiatry. 2011 Jun 1;69(11):e41-2. doi: 10.1016/j.biopsych.2011.02.012. Epub 2011 Apr 13. No abstract available.
- 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.
ChenCheng Zhang, MD contact
Kristina Zeljic, MSc contact
Bomin Sun, MD, PhD principal investigator
Ruijin Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Suzhou Sceneray® DBS System in people with Opiate Addiction, run by Ruijin Hospital at 2 sites 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 6 inclusion and 8 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 29 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 (i@cczhang.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weekly urine tests (time frame: Baseline (preoperative), 3 months, 6 months, 9 months, 12 months, 18 months, 24 months). 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 NCT02440152, which also lists 4 linked publications.
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 29 Jun 2017; AzTrials last refreshed its copy on 6 Nov 2026.