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Deep Brain Stimulation of Nucleus Accumbens to Prevent Opiate Relapse

This study is currently recruiting participants.
Verified July 2012 by Tang-Du Hospital
Sponsor:
Information provided by (Responsible Party):
Guodong Gao, Tang-Du Hospital
ClinicalTrials.gov Identifier:
NCT01274988
First received: January 11, 2011
Last updated: July 26, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition Intervention
Addiction
 Procedure: Deep brain stimulation
Other: methadone maintenance treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Deep Brain Stimulation of Nucleus Accumbens as a New Treatment to Prevent Relapse for Opiate Addicts

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Tang-Du Hospital:

Primary Outcome Measures:
  • Treatment retention [ Time Frame: 20 months ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Change of participants' craving for opioid drugs [ Time Frame: Baseline, 6 month, 12 month and 20month follow-up assessments ] [ Designated as safety issue: No ]
    The 10-point visual analog scale (VAS),will be utilized at each time point.

  • Change in Addiction Severity Index (ASI lite) composite scores [ Time Frame: Baseline, 6 month, 12 month and 20month follow-up assessments ] [ Designated as safety issue: No ]
  • Change in Opiate Withdrawal Scale(OWS)scores [ Time Frame: Baseline, 6 month, 12 month and 20month follow-up assessments ] [ Designated as safety issue: No ]
  • Psychological evaluation [ Time Frame: Baseline, 6 month, 12 month and 20month follow-up assessments ] [ Designated as safety issue: No ]
    The Hamilton Anxiety Scale (HAMA)for evaluating anxiety symptom,Beck Depression Inventory(BDI) for evaluating depression symptom,and Yale-Brown Obsessive Compulsive Scale (Y-BOCS) for evaluating obsessive compulsive symptom, will be utilized at each time point.

  • Personality evaluation [ Time Frame: Baseline, 6 month, 12 month and 20month follow-up assessments ] [ Designated as safety issue: No ]
    The Minnesota Multiphasic Personality Inventory (MMPI) and Eysenck Personality Questionnaire (EPQ)will be utilized at each time point.

  • Cognitive evaluation [ Time Frame: Baseline, 6 month, 12 month and 20month follow-up assessments ] [ Designated as safety issue: No ]
    The Wechsler Adult Intelligence Scale (WAIS)for evaluating the intelligence and Wechsler Memory Scale(WMS) for evaluating the memory will be utilized at each time point.

  • Evaluation of quality of life [ Time Frame: Baseline and 20 month follow-up assessments ] [ Designated as safety issue: No ]
    The MOS item short from health survey(SF-36) be utilized at each time point.


Estimated Enrollment: 40
Study Start Date: February 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Deep Brain Stimulation
Continuous deep brain stimulation of bilateral nucleus accumbens
 Procedure: Deep brain stimulation
Deep brain stimulation of bilateral nucleus accumbens
Active Comparator: Standard Control
methadone maintenance treatment
 Other: methadone maintenance treatment
methadone maintenance treatment

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  • IQ < 70 (evaluated with the WAIS)
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01274988

Contacts
Contact: Guo-dong Gao, M.D. +86 29 84777435 gguodong@fmmu.edu.cn
Contact: Xue-lian Wang, M.D. +86 29 84777284 wxlian@fmmu.edu.cn

Locations
China, Shaanxi
Department of neurosurgery, Tangdu Hospital Recruiting
Xi'an, Shaanxi, China, 710038
Contact: Guo-dong Gao, M.D.     +86 29 84777435     gguodong@fmmu.edu.cn    
Sub-Investigator: Xue-lian Wang, M.D.            
Sponsors and Collaborators
Tang-Du Hospital
Investigators
Principal Investigator: Guo-dong Gao, M.D. Department of neurosurgery, Tangdu Hospital
  More Information

No publications provided

Responsible Party: Guodong Gao, Department of Neurosurgery, Tang-Du Hospital
ClinicalTrials.gov Identifier: NCT01274988     History of Changes
Other Study ID Numbers: NACDBS
Study First Received: January 11, 2011
Last Updated: July 26, 2012
Health Authority: China: Ministry of Health

Keywords provided by Tang-Du Hospital:
Opiate dependence
Deep brain stimulation
Nucleus accumbens

Additional relevant MeSH terms:
Behavior, Addictive
Compulsive Behavior
Impulsive Behavior
Methadone
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents
Narcotics

ClinicalTrials.gov processed this record on May 23, 2013