Deep Brain Stimulation of Nucleus Accumbens to Prevent Opiate Relapse

Addiction Clinical Trial

Official title:

Deep Brain Stimulation of Nucleus Accumbens as a New Treatment to Prevent Relapse for Opiate Addicts

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01274988
• Other study ID #: NACDBS
• Status: Unknown status
• Phase: N/A
• First received: January 11, 2011
• Last updated: April 14, 2014
• Start date: February 2011
• Est. completion date: December 2015

Study information

• Verified date: April 2014
• Source: Tang-Du Hospital
• Contact: Guo-dong Gao, M.D.
• Phone: +86 29 84777435
• Email: gguodong[@]fmmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 20
• Est. completion date: December 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Addiction

Intervention

Procedure:
• Deep brain stimulation
Deep brain stimulation of bilateral nucleus accumbens

Other:
• methadone maintenance treatment
methadone maintenance treatment

Locations

Country	Name	City	State
China	Department of neurosurgery, Tangdu Hospital	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Tang-Du Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment retention	Opiate abstinent time by self-reports and monthly urinalysis for the patients undergo the deep brain stimulation of nucleus accumbens,treatment retention time for the methadone maintenance treatment patients	12 months
Secondary	Change of participants' craving for opioid drugs	The 10-point visual analog scale (VAS),will be utilized at each time point. A participants' diary will be utilized at each time point.	Baseline, 3 month, 6 month and 12month follow-up assessments
Secondary	Change in Addiction Severity Index (ASI lite) composite scores		Baseline, 3 month, 6 month and 12month follow-up assessments
Secondary	Psychological evaluation	The Symptom Checklist - 90 (SCL-90) for evaluating general status, Self-Rating Depression Scale (SDS)for evaluating depression symptom,and Yale-Brown Obsessive Compulsive Scale (Y-BOCS) for evaluating obsessive compulsive symptom, will be utilized at each time point.	Baseline, 3 month, 6 month and 12month follow-up assessments
Secondary	Personality evaluation	The Eysenck Personality Questionnaire (EPQ)will be utilized at each time point.	Baseline, 3 month, 6 month and 12month follow-up assessments
Secondary	Cognitive evaluation	The Wechsler Memory Scale(WMS) for evaluating the memory will be utilized at each time point.	Baseline, 3 month, 6 month and 12month follow-up assessments
Secondary	Evaluation of quality of life	The MOS item short from health survey(SF-36) be utilized at each time point.	Baseline, 3 month, 6 month and 12 month follow-up assessments
Secondary	Change in two static positron emission tomography(PET) images study	[18F]fluoro-D-glucose (FDG) for evaluating cerebral metabolism will be utilized at each time point.	Baseline and 6month follow-up