Clinical trial NCT01274988: Deep Brain Stimulation of Nucleus Accumbens to Prevent Opiate Relapse
Official title: Deep Brain Stimulation of Nucleus Accumbens as a New Treatment to Prevent Relapse for Opiate Addicts
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Addiction
Keywords: Opiate dependence
Deep brain stimulation
Nucleus accumbens
Lead sponsor: Tang-Du Hospital
Sponsor class: OTHER
First posted: 2011-01-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Treatment retention
timeFrame: 12 months
Secondary outcomes:
measure: Change of participants' craving for opioid drugs
timeFrame: Baseline, 3 month, 6 month and 12month follow-up assessments
measure: Change in Addiction Severity Index (ASI lite) composite scores
timeFrame: Baseline, 3 month, 6 month and 12month follow-up assessments
measure: Psychological evaluation
timeFrame: Baseline, 3 month, 6 month and 12month follow-up assessments
measure: Personality evaluation
timeFrame: Baseline, 3 month, 6 month and 12month follow-up assessments
measure: Cognitive evaluation
timeFrame: Baseline, 3 month, 6 month and 12month follow-up assessments
measure: Evaluation of quality of life
timeFrame: Baseline, 3 month, 6 month and 12 month follow-up assessments
measure: Change in two static positron emission tomography(PET) images study
timeFrame: Baseline and 6month follow-up
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Department of neurosurgery, Tangdu Hospital
state: Shaanxi
Study officials:
affiliation: Department of neurosurgery, Tangdu Hospital
name: Guo-dong Gao, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.