Treatment Methamphetamine Addiction
Conditions
Keywords
Bilateral Nucleus Accumbens, Methamphetamine Addiction
Brief summary
The main objective of this study is to assess the efficacy of bilateral deep brain stimulation (DBS) of the Nucleus Accumbens(NAc) as a novel treatment in severe methamphetamine addiction. Our hypothesis is that bilateral DBS of the NAc will significantly reduce the craving for methamphetamine.
Interventions
PROCEDUREBilateral surgical implantation of DBS system to NAc
The Medtronic, PINS and SceneRay DBS device will be utilized in the present study.
Sponsors
Ruijin Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
All subjects will receive bilateral surgical implantation of DBS system
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* DSM-IV-TR diagnosis of Drug addiction disorder; * Age 18-65 years old; * Proficiency in Mandarin language; * Failure to detox more than three times; * Capacity to provide informed consent (understanding of the study purpose and methods);
Exclusion criteria
* Multidrug abuse and formation of addiction; * Serious and unstable organic diseases (e.g. unstable coronal heart disease); * Any history of seizure disorder or hemorrhagic stroke; * Past stereotactic neurosurgical intervention; * Neurological disease (Abnormal PET-CT, MRI, EEG) * Contraindications of MRI-examination, e.g. implanted cardiac pacemaker/ heart defibrillator; * Contraindications of stereotactic intervention, e.g. increased bleeding disposition, cerebrovascular diseases (e.g. arteriovenous malfunction, aneurysms, systemic vascular diseases); * HIV positive; * Pregnancy and/or lactation;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in 10-point visual analog scale of carving | Baseline (preoperative),3 months,6 months, 12 months | The score of scale is from 0 to 10. 0 represents no carving for drug, 10 means the greatest degree of carving for drug. |
| change in Obsessive Compulsive Drug Use Scale | Baseline (preoperative),3 months,6 months, 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in the Hamilton Depression Scale | Baseline（preoperative）,3 months, 6 months, 12 months |
| Change in the Quality of Life Assessment (SF-36) | Baseline（preoperative）,3 months, 6 months, 12 months |
| Change in World Health Organization Quality of Life-BREF(WHO-BREF) | Baseline（preoperative）,3 months,6 months, 12 months |
| Side Effect | Baseline（preoperative）,3 months, 6 months, 12months |
| Neuropsychological measures(Scores of cognitive battery) | Baseline（preoperative）,6 months,12 months |
| Change in Fagerstrom Test of Nicotine Dependence(FTND) | Baseline（preoperative）,3 months,6 months, 12 months |
| Chang in Pittsburgh Sleep Quality Index | Baseline（preoperative）,3 months,6 months, 12 months |
| Change in the Hamilton Anxiety Scale | Baseline（preoperative）,3 months, 6 months, 12months |
Countries
China
Contacts
Primary ContactChencheng Zhang, MD
Outcome results
None listed