Deep Brain Stimulation of Nucleus Accumbens for Opioid Relapse Prevention

Tang-Du Hospital

Status: Unknown

Conditions: Addiction

Treatments: Device: Suzhou Sceneray® DBS System

Study type: Interventional

Funder types: Other

Identifiers

NCT03424616

NAcDBSORP

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups

Postoperative immediate Deep brain stimulation

Experimental group

Description:

The addicts undergone the deep brain stimulation while the stimulation (Suzhou Sceneray® DBS System) was turned on 1-2 weeks postoperatively.

Treatment:

Device: Suzhou Sceneray® DBS System

Postoperative delayed Deep brain stimulation

Sham Comparator group

Description:

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.

Treatment:

Device: Suzhou Sceneray® DBS System