- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02282072
PINS Stimulator System for Deep Brain Stimulation of the Nucleus Accumbens to Treat Severe Opioid Addiction
October 13, 2016 updated by: Beijing Pins Medical Co., Ltd
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 Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 310000
- Ruijin Hospital, Shanghai Jiaotong University School of Medicine
-
Contact:
- Bomin Sun, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Deep Brain Stimulation
Stimulator is ON
|
Other Names:
|
Sham Comparator: Placebo
Stimulator is OFF
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Schedule for the Assessment of Negative Symptoms (SANS)
Time Frame: 6 month
|
6 month
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Chronic Hunger Scale
Time Frame: 6 month
|
6 month
|
Beck Depression Inventory
Time Frame: 6 month
|
6 month
|
Buss & Perry Aggression Questionnaire
Time Frame: 6 month
|
6 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2016
Primary Completion (Anticipated)
September 1, 2018
Study Completion (Anticipated)
December 1, 2018
Study Registration Dates
First Submitted
September 26, 2014
First Submitted That Met QC Criteria
November 3, 2014
First Posted (Estimate)
November 4, 2014
Study Record Updates
Last Update Posted (Estimate)
October 14, 2016
Last Update Submitted That Met QC Criteria
October 13, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PINS-003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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