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Deep Brain Stimulation of Nucleus Accumbens to Prevent Opiate Relapse

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2014 by Guodong Gao, Tang-Du Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01274988
First Posted: January 12, 2011
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Guodong Gao, Tang-Du Hospital
  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
Intervention Model: Parallel Assignment
Masking: Single (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:


Further study details as provided by Guodong Gao, Tang-Du Hospital:

Primary Outcome Measures:
  • Treatment retention [ Time Frame: 12 months ]
    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, 3 month, 6 month and 12month follow-up assessments ]
    The 10-point visual analog scale (VAS),will be utilized at each time point. A participants' diary will be utilized at each time point.

  • Change in Addiction Severity Index (ASI lite) composite scores [ Time Frame: Baseline, 3 month, 6 month and 12month follow-up assessments ]
  • Psychological evaluation [ Time Frame: Baseline, 3 month, 6 month and 12month follow-up assessments ]
    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.

  • Personality evaluation [ Time Frame: Baseline, 3 month, 6 month and 12month follow-up assessments ]
    The Eysenck Personality Questionnaire (EPQ)will be utilized at each time point.

  • Cognitive evaluation [ Time Frame: Baseline, 3 month, 6 month and 12month follow-up assessments ]
    The Wechsler Memory Scale(WMS) for evaluating the memory will be utilized at each time point.

  • Evaluation of quality of life [ Time Frame: Baseline, 3 month, 6 month and 12 month follow-up assessments ]
    The MOS item short from health survey(SF-36) be utilized at each time point.

  • Change in two static positron emission tomography(PET) images study [ Time Frame: Baseline and 6month follow-up ]
    [18F]fluoro-D-glucose (FDG) for evaluating cerebral metabolism will be utilized at each time point.


Estimated Enrollment: 20
Study Start Date: February 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 2015 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
  • 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Guodong Gao, Department of Neurosurgery, Tang-Du Hospital
ClinicalTrials.gov Identifier: NCT01274988     History of Changes
Other Study ID Numbers: NACDBS
First Submitted: January 11, 2011
First Posted: January 12, 2011
Last Update Posted: October 12, 2017
Last Verified: April 2014

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

Additional relevant MeSH terms:
Methadone
Opiate Alkaloids
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents