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| Name | Class |
|---|---|
| National Institute on Drug Dependence, Peking University | UNKNOWN |
| Ruijin Hospital | OTHER |
| West China Hospital | OTHER |
| Nanfang Hospital, Southern Medical University |
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Nucleus accumbens plays important roles in the process of opiate addiction and initial of relapse after detoxification.According to the single-centered preliminary open-labeled prospective trial results, the investigators hypothesize that bilateral stimulation of the NAc will effectively reduce the relapse of the opiate dependence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Postoperative immediate Deep brain stimulation | Experimental | The addicts undergone the deep brain stimulation while the stimulation (Suzhou Sceneray® DBS System) was turned on 1-2 weeks postoperatively. |
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| Postoperative delayed Deep brain stimulation | Sham Comparator | The addicts undergone the deep brain stimulation while the stimulation (Suzhou Sceneray® DBS System) was off until 25 months postoperatively, during which the following up was kept, then the the stimulation was turned on 25 months postoperatively. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Suzhou Sceneray® DBS System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The abstinent rate at 25 weeks after DBS stimulation on （Urine Tests） | If the participants or their families report no less than 2 times of the drug use in each of two consecutive weeks, or the consecutive 2 times of urine tests showed positive, or lost of follow-up, the case was defined as relapse | At 25 weeks after DBS stimulation on |
| Measure | Description | Time Frame |
|---|---|---|
| The total days of abstinence for participants | The total days of abstinence for participants | Baseline (preoperative), 4 weeks, 12 weeks, 25 week after DBS stimulation on |
| The longest duration for sustained abstinence for participants |
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Inclusion Criteria:
18 years old < Age < 50 years old
Moderate to severe opiates abuse disorders (fulfilled diagnostic-criteria according to DSM-5)
Free patient's decision/informed Consent (existing comprehensive ability in meaning, methodology and execution of the study and ability of acceptance, known the benefit and risk of the treatment)
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guodong Gao, M.D. | Contact | +86 29 84717556 | gguodong@fmmu.edu.cn | |
| Lin Lu, M.D. | Contact | +86 13801027748 | linlu@bjmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Guodong Gao, M.D. | Department of neurosurgery, Tangdu Hospital | Principal Investigator |
| Lin Lu, M.D. | National Institute on Drug Dependence, Peking University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institute on Drug Dependence, Peking University | Recruiting | Beijing | Beijing Municipality | 100191 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30765398 | Derived | Qu L, Ge S, Li N, Wang W, Yang K, Wu P, Wang X, Shi J. Clinical evaluation of deep brain stimulation of nucleus accumbens/anterior limb of internal capsule for opioid relapse prevention: protocol of a multicentre, prospective and double-blinded study. BMJ Open. 2019 Feb 13;9(2):e023516. doi: 10.1136/bmjopen-2018-023516. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 22, 2026 | |
| Reset | Apr 8, 2026 | |
| Release | May 24, 2026 | |
| Reset | Jun 18, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 22, 2026 | Apr 8, 2026 | |||
| May 24, 2026 |
| ID | Term |
|---|---|
| D016739 | Behavior, Addictive |
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D003192 | Compulsive Behavior |
| D007175 | Impulsive Behavior |
| D001519 | Behavior |
| D000079524 | Narcotic-Related Disorders |
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| OTHER |
| Peking University First Hospital | OTHER |
Stagger-on design
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The longest duration for sustained abstinence for participants
| Baseline (preoperative), 4 weeks, 12 weeks, 25 week after DBS stimulation on |
| Visual analog scale (VAS) craving score for opioid drugs | Ranging from 0-10,with 0 indicates no craving while 10 indicates extreme craving | Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on |
| Body weight for participants | Body weight for participants | Baseline (preoperative), 4 weeks, 12 weeks, 25 week after DBS stimulation on |
| Hamilton Depression Scale（HAMD-17) | 17 items,Total scores<7: normal;7<Total scores<17:possible depression;17<Total scores<24:definite depression;Total score>24: severe depression | Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on |
| Scaling for Opiate withdrawal symptoms | There were 19 items for rating 19 withdrawl symptoms, with 0 indicating none and 4 indicating most severe, the total scores are obtained by summary for scores of each items, ranging from 0-76, the higher the total scores indicating the worsen opiate withdrawl symptoms. | Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on |
| The evaluation on MATRICS-test | Software system constructed by MATRICS company, which was used for evaluate the cognitive function of the participants | Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on |
| The rate of positive urine test results | times of positive urine test/ total times of urine test | Baseline (preoperative), 4 weeks, 12 weeks, 25 week after DBS stimulation on |
| Hamilton Anxiety Scale (HAMA) | 14 items, Total scores<6: normal;7<Total scores<14:possible anxiety;14<Total scores<21:definite anxiety;Total score>21: severe anxiety | Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on |
| Pittsburgh sleep quality index(PSQI) | Scaling for evaluating the sleep quality, the higher total scores indicating the more difficulties on sleep, thus the higher total scores indicating the worsen sleep quality | Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on |
| Fagerstrom Test Nicotine Dependence assessment (FTND) | Scaling for Nicotine Dependence: The higher of scores indicating higher lever of Nicotine Dependence | Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on |
| Social Disability Screening Schedule (SDSS) | Scaling for Social Disability with 10 items, the higher total scores indicating the much severe social disability | Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on |
| Activity of Daily Living Scale (ADL) | Consists of Physical Self-maintenance Scale and Instrumental Activities of Daily Living Scale, ranging from 0-56, total scores <14, normal; total score >14, ADL dysfunction | Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on |
| 36-Item Short Form Health Survey (SF-36) | Scaling for Quality of life with 8 subscales, the higher total scores indicating the better quality of life. | Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on |
| Nanfang Hospital Southern Medical University | Recruiting | Guangzhou | Guangdong | 510515 | China |
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| Department of neurosurgery, Tangdu Hospital | Recruiting | Xi'an | Shaanxi | 710038 | China |
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| Ruijin Hospital | Recruiting | Shanghai | Shanghai Municipality | 200020 | China |
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| West China Hospital | Recruiting | Chengdu | Sichuan | 610041 | China |
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| Jun 18, 2026 |
| D019966 |
| Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |