Substance-Related Disorders
Conditions
Keywords
drug addiction, Heroin, craving, event related potential, crystal methamphetamine
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.
Interventions
DEVICEEmotional pictures stimulation system
Emotional pictures stimulation system is component of neutral and drug-related images.
PROCEDUREDeep brain stimulation
Deep brain stimulation of bilateral NAc/ALIC
PROCEDUREadjacent contact stimulation
The electrode of deep brain stimulation has four contacts.We stimulate one contact,and record the local field potential of other contacts.
PROCEDUREmicroelectrode
We put the microelectrodes into bilateral nucleus accumbens and anterior limb of the internal capsule,to record the waveform of bilateral NAc/ALIC.
Sponsors
Tang-Du Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| the 13-item obsessive compulsive drug use scale(OCDUS) | day 3 | — |
| Opiate Addiction Severity Inventory(OASI) | day 3 | — |
| participants' craving for opioid drugs (VAS) | day 3 | The 10-point visual analog scale(VAS)will be utilized at day 3. |
| The Symptom Checklist-90(SCL-90) | day 3 | The Symptom Checklist-90(SCL-90) is used to evaluate general status. |
| 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. |
| 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 | — |
| Self-Rating Depression Scale(SDS) | day 3 | Self-Rating Depression Scale(SDS) is used to evaluate depression symptom. |
Countries
China
Contacts
Primary ContactGuo-dong Gao, M.D.
Backup ContactXue-lian Wang, M.D.
Outcome results
None listed