NCT03424616UnknownNot Applicable
Deep Brain Stimulation of Nucleus Accumbens for Opioid Relapse Prevention:A Multicenter Randomized Double-Blind Sham-stimulation Controlled Clinical Trial
Tang-Du Hospital5 sites in 1 country60 target enrollmentStarted: February 6, 2018Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 60
- Locations
- 5
- Primary Endpoint
- The abstinent rate at 25 weeks after DBS stimulation on （Urine Tests）
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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)
Exclusion Criteria
- •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
Arms & Interventions
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.
Intervention: Suzhou Sceneray® DBS System (Device)
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.
Intervention: Suzhou Sceneray® DBS System (Device)
Outcomes
Primary Outcomes
The abstinent rate at 25 weeks after DBS stimulation on （Urine Tests）
Time Frame: 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 Outcomes
- 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(Baseline (preoperative), 4 weeks, 12 weeks, 25 week after DBS stimulation on)
- The rate of positive urine test results(Baseline (preoperative), 4 weeks, 12 weeks, 25 week after DBS stimulation on)
- Pittsburgh sleep quality index(PSQI)(Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on)
- 36-Item Short Form Health Survey (SF-36)(Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on)
- Hamilton Depression Scale（HAMD-17)(Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on)
- Scaling for Opiate withdrawal symptoms(Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on)
- Visual analog scale (VAS) craving score for opioid drugs(Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on)
- The evaluation on MATRICS-test(Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on)
- Hamilton Anxiety Scale (HAMA)(Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on)
- Fagerstrom Test Nicotine Dependence assessment (FTND)(Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on)
- Body weight for participants(Baseline (preoperative), 4 weeks, 12 weeks, 25 week after DBS stimulation on)
- Social Disability Screening Schedule (SDSS)(Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on)
- Activity of Daily Living Scale (ADL)(Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on)
Investigators
Study Sites (5)
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