The Effectiveness of Deep Brain Stimulation for Opioid Relapse Prevention

Shanghai Jiao Tong University

Status and phase

Unknown

Phase 3

Phase 2

Conditions

Opiate Addiction

Treatments

Device: Suzhou Sceneray® DBS System

Study type

Interventional

Funder types

Other

Identifiers

NCT02440152

2014-15

Details and patient eligibility

About

The nucleus accumbens (NAcc) has a significant role in the process of opiate addiction and the initiation of relapse after detoxification. There is evidence that deep brain stimulation (DBS) of the NAcc exerts a positive effect on individuals with severe heroin addiction via inhibitory action .

The investigators hypothesise that bilateral stimulation of the NAcc will significantly reduce withdrawal symptoms and thus enable the patients to substantially decrease their Levomethadone usage.

Enrollment

6 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Proficiency in Mandarin language
Long lasting heroin addiction (determined by diagnostic-criteria in Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition)
Duration longer than 6 months
A lack of response to long-term treatment
Capacity to provide informed consent (understanding of the study purpose and methods)
Substitution methadone treatment at a constant dose within three months prior to inclusion.

Exclusion criteria

Clinical relevant psychiatric comorbidity (schizophrenic psychoses, bipolar affective diseases with psychotic symptoms)(MINI 6.0)
Past stereotactic neurosurgical intervention
Neurological disease (Abnormal PET-CT, MRI, EEG)
Contraindications of MRI-examination, e.g. implanted cardiac pacemaker/ heart defibrillator
Contraindications of stereotactic intervention, e.g. increased bleeding-disposition, cerebrovascular diseases (e.g. arteriovenous malfunction, aneurysms, systemic vascular diseases)
Serious and unstable organic diseases (e.g. unstable coronal heart disease)
HIV positive
Pregnancy and/or lactation