Clinical trial NCT03424616: Deep Brain Stimulation of Nucleus Accumbens for Opioid Relapse Prevention
Official title: Deep Brain Stimulation of Nucleus Accumbens for Opioid Relapse Prevention:A Multicenter Randomized Double-Blind Sham-stimulation Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Addiction
Keywords: Opiate dependence
Deep brain stimulation
Nucleus accumbens
Lead sponsor: Tang-Du Hospital
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Dependence, Peking University
name: Ruijin Hospital
name: West China Hospital
name: Nanfang Hospital, Southern Medical University
name: Peking University First Hospital
First posted: 2018-02-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Stagger-on design
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 18 years old \< Age \< 50 years old
* Moderate to severe opiates abuse disorders (fulfilled diagnostic-criteria according to DSM-5)

  1. History of opiates abuse no less than 3 years
  2. Failure of at least three addiction treatments ( in hospital or compulsive rehabilitation）, among which failure of methadone maintenance treatment must be met
  3. 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

Primary outcomes:
measure: The abstinent rate at 25 weeks after DBS stimulation on （Urine Tests）
timeFrame: At 25 weeks after DBS stimulation on
Secondary outcomes:
measure: The total days of abstinence for participants
timeFrame: Baseline (preoperative), 4 weeks, 12 weeks, 25 week after DBS stimulation on
measure: The longest duration for sustained abstinence for participants
timeFrame: Baseline (preoperative), 4 weeks, 12 weeks, 25 week after DBS stimulation on
measure: Visual analog scale (VAS) craving score for opioid drugs
timeFrame: Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on
measure: Body weight for participants
timeFrame: Baseline (preoperative), 4 weeks, 12 weeks, 25 week after DBS stimulation on
measure: Hamilton Depression Scale（HAMD-17)
timeFrame: Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on
measure: Scaling for Opiate withdrawal symptoms
timeFrame: Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on
measure: The evaluation on MATRICS-test
timeFrame: Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on
measure: The rate of positive urine test results
timeFrame: Baseline (preoperative), 4 weeks, 12 weeks, 25 week after DBS stimulation on
measure: Hamilton Anxiety Scale (HAMA)
timeFrame: Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on
measure: Pittsburgh sleep quality index(PSQI)
timeFrame: Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on
measure: Fagerstrom Test Nicotine Dependence assessment (FTND)
timeFrame: Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on
measure: Social Disability Screening Schedule (SDSS)
timeFrame: Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on
measure: Activity of Daily Living Scale (ADL)
timeFrame: Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on
measure: 36-Item Short Form Health Survey (SF-36)
timeFrame: Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on
Other outcomes:
Locations:
city: Beijing
country: China
facility: National Institute on Drug Dependence, Peking University
state: Beijing
city: Guangzhou
country: China
facility: Nanfang Hospital Southern Medical University
state: Guangdong
city: Xi'an
country: China
facility: Department of neurosurgery, Tangdu Hospital
state: Shaanxi
city: Shanghai
country: China
facility: Ruijin Hospital
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital
state: Si Chuan
Study officials:
affiliation: Department of neurosurgery, Tangdu Hospital
name: Guodong Gao, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: National Institute on Drug Dependence, Peking University
name: Lin Lu, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.