Deep Brain Stimulation of Nucleus Accumbens to Prevent Opiate Relapse
NCT ID: NCT01274988
Last Updated: 2014-04-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2011-02-28
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Deep Brain Stimulation
Continuous deep brain stimulation of bilateral nucleus accumbens
Deep brain stimulation
Deep brain stimulation of bilateral nucleus accumbens
Standard Control
methadone maintenance treatment
methadone maintenance treatment
methadone maintenance treatment
Interventions
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Deep brain stimulation
Deep brain stimulation of bilateral nucleus accumbens
methadone maintenance treatment
methadone maintenance treatment
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Tang-Du Hospital
OTHER
Responsible Party
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Guodong Gao
Department of Neurosurgery
Principal Investigators
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Guo-dong Gao, M.D.
Role: PRINCIPAL_INVESTIGATOR
Department of neurosurgery, Tangdu Hospital
Locations
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Department of neurosurgery, Tangdu Hospital
Xi'an, Shaanxi, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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NACDBS
Identifier Type: -
Identifier Source: org_study_id
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