Clinical trial NCT02594306: Brain Electrophysiological Study(EEG/ERP) on Opiate Addicts Treating by Bilateral NAc/ALIC Deep Brain Stimulation
Official title: Brain Electrophysiological Study(EEG/ERP) on Opiate Addicts Treating by Bilateral NAc/ALIC Deep Brain Stimulation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Substance-Related Disorders
Keywords: drug addiction
Heroin
craving
event related potential
crystal methamphetamine
Lead sponsor: Tang-Du Hospital
Sponsor class: OTHER
First posted: 2015-11-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Effective treatments for severe drug addiction are limited. China centers employing compulsory detoxification, reported a 3 year abstinence rate of only 15%. For the methadone maintenance therapy, relapse often occurs promptly after cessation of methadone. A Malaysian reports about taking naltrexone or buprenorphine treating,showed average relapsed time of 2 or 3 months,respectively.

Assessment for psychological craving degree of addiction patients is also a difficult thing.

Eligibility criteria: 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.

Primary outcomes:
measure: Event related potentials(ERPs)
timeFrame: Day 3
Secondary outcomes:
measure: local field potential(LFP)
timeFrame: in surgery,3 days after surgery
measure: the 13-item obsessive compulsive drug use scale(OCDUS)
timeFrame: day 3
measure: Opiate Addiction Severity Inventory(OASI)
timeFrame: day 3
measure: participants' craving for opioid drugs (VAS)
timeFrame: day 3
measure: The Symptom Checklist-90(SCL-90)
timeFrame: day 3
measure: Self-Rating Depression Scale(SDS)
timeFrame: day 3
measure: Yale-Brown Obsessive Compulsive Scale(Y-BOCS)
timeFrame: day 3
measure: The Eysenck Personality Questionnaire(EPQ)
timeFrame: day 3
measure: The Wechsler Memory Scale(WMS)
timeFrame: day 3
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: STUDY_CHAIR
References: