Deep Brain Stimulation of Nucleus Accumbens to Prevent Opiate Relapse
1 other identifier
interventional
20
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 11, 2011
CompletedFirst Posted
Study publicly available on registry
January 12, 2011
CompletedStudy Start
First participant enrolled
February 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedApril 16, 2014
April 1, 2014
4.3 years
January 11, 2011
April 14, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
Change of participants' craving for opioid drugs
Baseline, 3 month, 6 month and 12month follow-up assessments
Change in Addiction Severity Index (ASI lite) composite scores
Baseline, 3 month, 6 month and 12month follow-up assessments
Psychological evaluation
Baseline, 3 month, 6 month and 12month follow-up assessments
Personality evaluation
Baseline, 3 month, 6 month and 12month follow-up assessments
Cognitive evaluation
Baseline, 3 month, 6 month and 12month follow-up assessments
- +2 more secondary outcomes
Study Arms (2)
Deep Brain Stimulation
EXPERIMENTALContinuous deep brain stimulation of bilateral nucleus accumbens
Standard Control
ACTIVE COMPARATORmethadone maintenance treatment
Interventions
Deep brain stimulation of bilateral nucleus accumbens
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tang-Du Hospitallead
Study Sites (1)
Department of neurosurgery, Tangdu Hospital
Xi'an, Shaanxi, 710038, China
Related Publications (1)
Chen L, Li N, Ge S, Lozano AM, Lee DJ, Yang C, Li L, Bai Q, Lu H, Wang J, Wang X, Li J, Jing J, Su M, Wei L, Wang X, Gao G. Long-term results after deep brain stimulation of nucleus accumbens and the anterior limb of the internal capsule for preventing heroin relapse: An open-label pilot study. Brain Stimul. 2019 Jan-Feb;12(1):175-183. doi: 10.1016/j.brs.2018.09.006. Epub 2018 Sep 14.
PMID: 30245163DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Guo-dong Gao, M.D.
Department of neurosurgery, Tangdu Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Department of Neurosurgery
Study Record Dates
First Submitted
January 11, 2011
First Posted
January 12, 2011
Study Start
February 1, 2011
Primary Completion
June 1, 2015
Study Completion
December 1, 2015
Last Updated
April 16, 2014
Record last verified: 2014-04