Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Nucleus accumbens plays important roles in the process of opiate addiction and initial of relapse after detoxification, deep brain stimulation of nucleus accumbens will inhibit its activity and thus to effectively prevent the relapse of the opiate dependence.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Deep Brain Stimulation | Experimental | Continuous deep brain stimulation of bilateral nucleus accumbens |
|
| Standard Control | Active Comparator | methadone maintenance treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deep brain stimulation | Procedure | Deep brain stimulation of bilateral nucleus accumbens |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment retention | Opiate abstinent time by self-reports and monthly urinalysis for the patients undergo the deep brain stimulation of nucleus accumbens,treatment retention time for the methadone maintenance treatment patients | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change of participants' craving for opioid drugs | The 10-point visual analog scale (VAS),will be utilized at each time point. A participants' diary will be utilized at each time point. | Baseline, 3 month, 6 month and 12month follow-up assessments |
| Change in Addiction Severity Index (ASI lite) composite scores |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guo-dong Gao, M.D. | Contact | +86 29 84777435 | gguodong@fmmu.edu.cn | |
| Xue-lian Wang, M.D. | Contact | +86 29 84777284 | wxlian@fmmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Guo-dong Gao, M.D. | Department of neurosurgery, Tangdu Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of neurosurgery, Tangdu Hospital | Recruiting | Xi'an | Shaanxi | 710038 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30245163 | Derived | Chen L, Li N, Ge S, Lozano AM, Lee DJ, Yang C, Li L, Bai Q, Lu H, Wang J, Wang X, Li J, Jing J, Su M, Wei L, Wang X, Gao G. Long-term results after deep brain stimulation of nucleus accumbens and the anterior limb of the internal capsule for preventing heroin relapse: An open-label pilot study. Brain Stimul. 2019 Jan-Feb;12(1):175-183. doi: 10.1016/j.brs.2018.09.006. Epub 2018 Sep 14. |
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 9, 2017 | |
| Reset | Mar 28, 2017 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 9, 2017 | Mar 28, 2017 |
| ID | Term |
|---|---|
| D016739 | Behavior, Addictive |
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D003192 | Compulsive Behavior |
| D007175 | Impulsive Behavior |
| D001519 | Behavior |
| D000079524 | Narcotic-Related Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D046690 | Deep Brain Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| methadone maintenance treatment | Other | methadone maintenance treatment |
|
| Baseline, 3 month, 6 month and 12month follow-up assessments |
| Psychological evaluation | The Symptom Checklist - 90 (SCL-90) for evaluating general status, Self-Rating Depression Scale (SDS)for evaluating depression symptom,and Yale-Brown Obsessive Compulsive Scale (Y-BOCS) for evaluating obsessive compulsive symptom, will be utilized at each time point. | Baseline, 3 month, 6 month and 12month follow-up assessments |
| Personality evaluation | The Eysenck Personality Questionnaire (EPQ)will be utilized at each time point. | Baseline, 3 month, 6 month and 12month follow-up assessments |
| Cognitive evaluation | The Wechsler Memory Scale(WMS) for evaluating the memory will be utilized at each time point. | Baseline, 3 month, 6 month and 12month follow-up assessments |
| Evaluation of quality of life | The MOS item short from health survey(SF-36) be utilized at each time point. | Baseline, 3 month, 6 month and 12 month follow-up assessments |
| Change in two static positron emission tomography(PET) images study | [18F]fluoro-D-glucose (FDG) for evaluating cerebral metabolism will be utilized at each time point. | Baseline and 6month follow-up |
| D019966 |
| Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |