Brain Electrophysiological Study(EEG/ERP) on Opiate Addicts Treating by Bilateral NAc/ALIC Deep Brain Stimulation

Not Applicable

• Conditions: Substance-Related Disorders

• Registration Number: NCT02594306
• Lead Sponsor: Tang-Du Hospital

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.

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-14
• Study First Submitted QC: 2015-11-02
• Study First Posted: 2015-11-03
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-17
• Last Update Posted: 2016-02-19
• Primary Completion: 2016-11
• Study Completion: 2016-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Event related potentials(ERPs)	Day 3	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.

Secondary Outcome Measures

Name	Time	Method
Self-Rating Depression Scale(SDS)	day 3	Self-Rating Depression Scale(SDS) is used to evaluate depression symptom.
participants' craving for opioid drugs (VAS)	day 3	The 10-point visual analog scale(VAS)will be utilized at day 3.
Yale-Brown Obsessive Compulsive Scale(Y-BOCS)	day 3	Yale-Brown Obsessive Compulsive Scale(Y-BOCS) is used to evaluate obsessive compulsive symptom.
The Eysenck Personality Questionnaire(EPQ)	day 3
The Wechsler Memory Scale(WMS)	day 3
local field potential(LFP)	in surgery,3 days after surgery	Recording the LFP of DBS group without any stimulation and stimulate one contact in surgery and 3 days after surgery.
the 13-item obsessive compulsive drug use scale(OCDUS)	day 3
Opiate Addiction Severity Inventory(OASI)	day 3
The Symptom Checklist-90(SCL-90)	day 3	The Symptom Checklist-90(SCL-90) is used to evaluate general status.

Trial Locations

Locations (1)

Department of neurosurgery, Tangdu Hospital; 🇨🇳 Xi'an, Shaanxi, China