Deep Brain Stimulation of Nucleus Accumbens to Prevent Opiate Relapse

Tang-Du Hospital

Status: Unknown

Conditions: Addiction

Treatments: Procedure: Deep brain stimulation; Other: methadone maintenance treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT01274988

NACDBS

Details and patient eligibility

About

Nucleus accumbens plays important roles in the process of opiate addiction and initial of relapse after detoxification, deep brain stimulation of nucleus accumbens will inhibit its activity and thus to effectively prevent the relapse of the opiate dependence.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age > 18 years old
• Long lasting heroin addiction (fulfilled diagnostic-criteria according to ICD-10)
• At least three detoxication-treatments without a long-term period of abstinence has already taken place
• Long-term inpatient treatment to support abstinence have occurred
• completion of detoxification treatment preoperatively with no somatic symptoms of withdrawal
• negative morphine urinalysis and naloxone tests
• Free patient's decision/informed Consent (existing comprehensive ability in meaning, methodology and execution of the study and ability of acceptance)

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
• Current and in the last six months existent paranoid-hallucinated symptomatology
• Foreign aggressiveness in the last six months
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Deep Brain Stimulation

Experimental group

Description:

Continuous deep brain stimulation of bilateral nucleus accumbens

Treatment:

Procedure: Deep brain stimulation

Standard Control

Active Comparator group

Description:

methadone maintenance treatment

Treatment:

Other: methadone maintenance treatment