Status:
UNKNOWN
Deep Brain Stimulation of Nucleus Accumbens for Opioid Relapse Prevention
Lead Sponsor:
Tang-Du Hospital
Collaborating Sponsors:
National Institute on Drug Dependence, Peking University
Ruijin Hospital
Conditions:
Addiction
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief Summary
Nucleus accumbens plays important roles in the process of opiate addiction and initial of relapse after detoxification.According to the single-centered preliminary open-labeled prospective trial resul...
Eligibility Criteria
Inclusion
- 18 years old \< Age \< 50 years old
- Moderate to severe opiates abuse disorders (fulfilled diagnostic-criteria according to DSM-5)
- History of opiates abuse no less than 3 years
- Failure of at least three addiction treatments ( in hospital or compulsive rehabilitation）, among which failure of methadone maintenance treatment must be met
- completion of detoxification ( Negative urine test for morphine, methamphetamine, ketamine and buprenorphine)
- Free patient's decision/informed Consent (existing comprehensive ability in meaning, methodology and execution of the study and ability of acceptance, known the benefit and risk of the treatment)
Exclusion
- Clinical relevant psychiatric comorbidity (schizophrenic psychoses, bipolar affective diseases, severe personality disorder)
- Contraindications of a MRI-examination, e.g. implanted cardiac pacemaker/heart defibrillator
- Abuse of other type of drugs
- severe cognitive impairments
- Enrollment in other clinical trials
- 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
- Severe disorders for coagulation and liver function
- Epilepsy or other severe brain trauma or neurological impairments
Key Trial Info
Start Date :
February 6 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 30 2020
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03424616
Start Date
February 6 2018
End Date
January 30 2020
Last Update
February 7 2018
Active Locations (5)
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1
National Institute on Drug Dependence, Peking University
Beijing, Beijing Municipality, China, 100191
2
Nanfang Hospital Southern Medical University
Guangzhou, Guangdong, China, 510515
3
Department of neurosurgery, Tangdu Hospital
Xi'an, Shaanxi, China, 710038
4
Ruijin Hospital
Shanghai, Shanghai Municipality, China, 200020