Opioid AddictionEarly Phase 1NCT02282072
PINS Stimulator System for Deep Brain Stimulation of the Nucleus Accumbens to Treat Severe Opioid Addiction
A Early Phase 1 study testing Deep brain stimulation：PINS Stimulation System in people with Opioid Addiction, run by Beijing Pins Medical Co., Ltd at 1 site in China.
Trial summary
The purpose of this study is to verify efficacy and safety of a bilateral deep brain stimulation (DBS) of the Nucleus accumbens (NAc) as a treatment option for severe opioid addiction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Addiction
- What is being tested?
- Deep brain stimulation：PINS Stimulation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Dec 2016to Dec 2018
- Phase
- Early Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years old.
- In accordance with the diagnostic standards of DSM-IV \& ICD-10 for addicted and DSM-IV for abstinence.
- Qualitative urine detection for opioids showing positive result.
- Cleared for 8 to 36 hours after their last drug taking.
- Fully understood and signed on informed consent.
Who cannot join
- Person with consciousness disorder on opioid abstinence, seriously aggressive, heavily dehydrated and intending to commit suicide.
- Patients with serious liver and kidney dysfunction, pulmonary decompensation, or complicated with serious damage in other systems.
- Patients with serious infectious disease.
- Patients with history of serious neurological or psychiatrical diseases.
- Person with history of HIV infection or serious malnutrition.
- Dependent upon and addicted to multiple drugs.
- Attended some other drug trials within one month.
Trial locations and contacts
1 site in 1 country.
China1 site
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 310000
Bomin Sun, MD
About this study
The purpose of this study is to verify efficacy and safety of a bilateral deep brain stimulation (DBS) of the Nucleus accumbens (NAc) as a treatment option for severe opioid addiction.
- Conditions
- Opioid Addiction
- Being tested
- Deep brain stimulation：PINS Stimulation 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.
Deep brain stimulation：PINS Stimulation SystemDevice
Also called Non-rechargeable Implanted device
| Study group | Role | What they receive |
|---|---|---|
| Deep Brain Stimulation | Active comparator | Stimulator is ON Receives: Device: Deep brain stimulation：PINS Stimulation System |
| Placebo | Sham comparator | Stimulator is OFF Receives: Device: Deep brain stimulation：PINS Stimulation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Schedule for the Assessment of Negative Symptoms (SANS)
Measured: 6 month
Secondary outcomes (3)
Chronic Hunger Scale
Measured: 6 month
Beck Depression Inventory
Measured: 6 month
Buss & Perry Aggression Questionnaire
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2014 (estimated)
- Study startDec 2016
- Primary completionSep 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid AddictionStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Pins Medical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Beijing Tiantan Hospital
- Responsible party
- Sponsor
- Investigators
- Li Luming, PhD, Study chair, Tsinghua University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02282072
- Sponsor's protocol ID
- PINS-003
- Status last verified
- Aug 2016
- First submitted
- 26 Sep 2014
- Last updated
- 14 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PINS Stimulator System for Deep Brain Stimulation of the Nucleus Accumbens to Treat Severe Opioid Addiction
- ClinicalTrials.gov ID
- NCT02282072
- Acronym / sponsor ID
- PINS-003
- Conditions
- Opioid Addiction
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Beijing Pins Medical Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Beijing Tiantan Hospital
- Study start
- Dec 2016
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 4 Nov 2014 (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 purpose of this study is to verify efficacy and safety of a bilateral deep brain stimulation (DBS) of the Nucleus accumbens (NAc) as a treatment option for severe opioid addiction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deep Brain Stimulation | Active comparator | Device: Deep brain stimulation：PINS Stimulation SystemStimulator is ON |
| Placebo | Sham comparator | Device: Deep brain stimulation：PINS Stimulation SystemStimulator is OFF |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age > 18 years old.
- In accordance with the diagnostic standards of DSM-IV \& ICD-10 for addicted and DSM-IV for abstinence.
- Qualitative urine detection for opioids showing positive result.
- Cleared for 8 to 36 hours after their last drug taking.
- Fully understood and signed on informed consent.
Key exclusion criteria (7 listed)
- Person with consciousness disorder on opioid abstinence, seriously aggressive, heavily dehydrated and intending to commit suicide.
- Patients with serious liver and kidney dysfunction, pulmonary decompensation, or complicated with serious damage in other systems.
- Patients with serious infectious disease.
- Patients with history of serious neurological or psychiatrical diseases.
- Person with history of HIV infection or serious malnutrition.
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：PINS Stimulation SystemAlso: Non-rechargeable Implanted device | Device | Deep Brain Stimulation, Placebo |
Primary outcome
Schedule for the Assessment of Negative Symptoms (SANS)
Time frame: 6 month
3 secondary outcomes
Chronic Hunger Scale
Time frame: 6 month
Beck Depression Inventory
Time frame: 6 month
Buss & Perry Aggression Questionnaire
Time frame: 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2016.
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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.
Li Luming, PhD study chair
Tsinghua University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Deep brain stimulation：PINS Stimulation System in people with Opioid Addiction, run by Beijing Pins Medical Co., Ltd 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 7 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 14 Oct 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 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Jia Fumin, PhD (+86 010-59361265, pins_medical@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Schedule for the Assessment of Negative Symptoms (SANS) (time frame: 6 month). 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 14 Oct 2016.