Substance-Related Disorders Clinical Trial
Official title:
Brain Electrophysiological Study(EEG/ERP) on Opiate Addicts Treating by Bilateral NAc/ALIC Deep Brain Stimulation
Drug addiction is compulsive and spontaneous drug-taking behavior which is characterized by non-medical usage, long and repeated exposure to addictive drugs and gradually increasing drug-taking dosage and frequency,and become a main threat against human being's public health, economic development and social safety.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | November 2016 |
Est. primary completion date | November 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 50 Years |
Eligibility |
Inclusion Criteria: 1. Age between 18 and 65 years of age, male or female; 2. Opiate addictive over 3 years; 3. Physical detoxification completed(keep abstinent for at least 7 days,acute abstinent syndrome disappeared,morphine urinalysis and naloxone test showed negative); 4. No obvious neuropsychiatry and personality disorders; 5. No severe infectious disease; 6. Good compliance and be able to complete follow up; 7. General health is good,no severe liver?kidney?heart and lung disease; 8. Informed consent issued Exclusion Criteria: 1. Severe cognitive disorders(MMSE scale: illiteracy=17,primary school=20,secondary school or above=24),bad compliance because of dementia,unable to issue the informed content; 2. History of severe neuropsychiatric disease; 3. Epilepsy; 4. severe liver?kidney?heart and lung disease, severe hypertension and severe orthostatic hypotension; 5. Malignant tumor;History of brain trauma;Pregnant female; 6. Patients are taking part in other clinical trials in recent 3 months; 7. Being deem as unfit for the trials by researcher. |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Department of neurosurgery, Tangdu Hospital | Xi'an | Shaanxi |
Lead Sponsor | Collaborator |
---|---|
Tang-Du Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Event related potentials(ERPs) | Event related potentials include late positive potential(LPP),P300,mismatch negativity(MMN) and N400.Recording the event related potential when people receive the stimulus of emotional pictures stimulation system. | Day 3 | No |
Secondary | local field potential(LFP) | Recording the LFP of DBS group without any stimulation and stimulate one contact in surgery and 3 days after surgery. | in surgery,3 days after surgery | No |
Secondary | the 13-item obsessive compulsive drug use scale(OCDUS) | day 3 | No | |
Secondary | Opiate Addiction Severity Inventory(OASI) | day 3 | No | |
Secondary | participants' craving for opioid drugs (VAS) | The 10-point visual analog scale(VAS)will be utilized at day 3. | day 3 | No |
Secondary | The Symptom Checklist-90(SCL-90) | The Symptom Checklist-90(SCL-90) is used to evaluate general status. | day 3 | No |
Secondary | Self-Rating Depression Scale(SDS) | Self-Rating Depression Scale(SDS) is used to evaluate depression symptom. | day 3 | No |
Secondary | Yale-Brown Obsessive Compulsive Scale(Y-BOCS) | Yale-Brown Obsessive Compulsive Scale(Y-BOCS) is used to evaluate obsessive compulsive symptom. | day 3 | No |
Secondary | The Eysenck Personality Questionnaire(EPQ) | day 3 | No | |
Secondary | The Wechsler Memory Scale(WMS) | day 3 | No |
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