Deep Brain Stimulation of Nucleus Accumbens for Opioid Relapse Prevention
- Conditions
- Addiction
- Interventions
- Device: Suzhou Sceneray® DBS System
- Registration Number
- NCT03424616
- Lead Sponsor
- Tang-Du Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
-
18 years old < Age < 50 years old
-
Moderate to severe opiates abuse disorders (fulfilled diagnostic-criteria according to DSM-5)
- History of opiates abuse no less than 3 years
- Failure of at least three addiction treatments ( in hospital or compulsive rehabilitation）, among which failure of methadone maintenance treatment must be met
- completion of detoxification ( Negative urine test for morphine, methamphetamine, ketamine and buprenorphine)
-
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)
- Clinical relevant psychiatric comorbidity (schizophrenic psychoses, bipolar affective diseases, severe personality disorder)
- Contraindications of a MRI-examination, e.g. implanted cardiac pacemaker/heart defibrillator
- Abuse of other type of drugs
- severe cognitive impairments
- Enrollment in other clinical trials
- Stereotactic respectively neurosurgical intervention in the past
- Contraindications of a stereotactic operation, e.g. increased bleeding-disposition, cerebrovascular diseases (e.g. arteriovenous malfunction, aneurysms, systemic vascular diseases)
- Serious and instable organic diseases (e.g. instable coronal heart disease)
- tested positively for HIV
- pregnancy and/or lactation
- Severe disorders for coagulation and liver function
- Epilepsy or other severe brain trauma or neurological impairments
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Postoperative delayed Deep brain stimulation Suzhou Sceneray® DBS System 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. Postoperative immediate Deep brain stimulation Suzhou Sceneray® DBS System The addicts undergone the deep brain stimulation while the stimulation (Suzhou Sceneray® DBS System) was turned on 1-2 weeks postoperatively.
- Primary Outcome Measures
Name Time Method The abstinent rate at 25 weeks after DBS stimulation on （Urine Tests） At 25 weeks after DBS stimulation on 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
- Secondary Outcome Measures
Name Time Method The total days of abstinence for participants Baseline (preoperative), 4 weeks, 12 weeks, 25 week after DBS stimulation on The total days of abstinence for participants
The longest duration for sustained abstinence for participants Baseline (preoperative), 4 weeks, 12 weeks, 25 week after DBS stimulation on The longest duration for sustained abstinence for participants
The rate of positive urine test results Baseline (preoperative), 4 weeks, 12 weeks, 25 week after DBS stimulation on times of positive urine test/ total times of urine test
Pittsburgh sleep quality index(PSQI) Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on 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
36-Item Short Form Health Survey (SF-36) Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on Scaling for Quality of life with 8 subscales, the higher total scores indicating the better quality of life.
Hamilton Depression Scale（HAMD-17) Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on 17 items,Total scores\<7: normal;7\<Total scores\<17:possible depression;17\<Total scores\<24:definite depression;Total score\>24: severe depression
Scaling for Opiate withdrawal symptoms Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on 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.
Body weight for participants Baseline (preoperative), 4 weeks, 12 weeks, 25 week after DBS stimulation on Body weight for participants
Visual analog scale (VAS) craving score for opioid drugs Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on Ranging from 0-10,with 0 indicates no craving while 10 indicates extreme craving
The evaluation on MATRICS-test Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on Software system constructed by MATRICS company, which was used for evaluate the cognitive function of the participants
Hamilton Anxiety Scale (HAMA) Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on 14 items, Total scores\<6: normal;7\<Total scores\<14:possible anxiety;14\<Total scores\<21:definite anxiety;Total score\>21: severe anxiety
Fagerstrom Test Nicotine Dependence assessment (FTND) Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on Scaling for Nicotine Dependence: The higher of scores indicating higher lever of Nicotine Dependence
Social Disability Screening Schedule (SDSS) Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on Scaling for Social Disability with 10 items, the higher total scores indicating the much severe social disability
Activity of Daily Living Scale (ADL) Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on 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
Trial Locations
- Locations (5)
West China Hospital
🇨🇳Chengdu, Si Chuan, China
Nanfang Hospital Southern Medical University
🇨🇳Guangzhou, Guangdong, China
Ruijin Hospital
🇨🇳Shanghai, Shanghai, China
Department of neurosurgery, Tangdu Hospital
🇨🇳Xi'an, Shaanxi, China
National Institute on Drug Dependence, Peking University
🇨🇳Beijing, Beijing, China