Deep Brain Stimulation of Nucleus Accumbens to Prevent Opiate Relapse

NCT ID: NCT01274988

Last Updated: 2014-04-16

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Addiction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Deep Brain Stimulation

Continuous deep brain stimulation of bilateral nucleus accumbens

Group Type EXPERIMENTAL

Deep brain stimulation

Intervention Type PROCEDURE

Deep brain stimulation of bilateral nucleus accumbens

Standard Control

methadone maintenance treatment

Group Type ACTIVE_COMPARATOR

methadone maintenance treatment

Intervention Type OTHER

methadone maintenance treatment

Interventions

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Deep brain stimulation

Deep brain stimulation of bilateral nucleus accumbens

Intervention Type PROCEDURE

methadone maintenance treatment

methadone maintenance treatment

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tang-Du Hospital

OTHER

Sponsor Role lead

Responsible Party

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Guodong Gao

Department of Neurosurgery

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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China

Central Contacts

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Guo-dong Gao, M.D.

Role: CONTACT

+86 29 84777435

Xue-lian Wang, M.D.

Role: CONTACT

+86 29 84777284

Facility Contacts

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Guo-dong Gao, M.D.

Role: primary

+86 29 84777435

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.

Reference Type DERIVED
PMID: 30245163 (View on PubMed)

Other Identifiers

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NACDBS

Identifier Type: -

Identifier Source: org_study_id

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