Treatment Methamphetamine Addiction Clinical Trial
Official title:
Deep Brain Stimulation of Nucleus Accumbens for Methamphetamine Addiction
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.
| Status | Recruiting |
| Enrollment | 10 |
| Est. completion date | December 30, 2020 |
| Est. primary completion date | September 20, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility |
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; |
| Country | Name | City | State |
|---|---|---|---|
| China | Shanghai Ruijin Hospital Functional Neurosurgery | Shanghai | Shanghai |
| Lead Sponsor | Collaborator |
|---|---|
| Ruijin Hospital |
China,
Kuhn J, Möller M, Treppmann JF, Bartsch C, Lenartz D, Gruendler TO, Maarouf M, Brosig A, Barnikol UB, Klosterkötter J, Sturm V. Deep brain stimulation of the nucleus accumbens and its usefulness in severe opioid addiction. Mol Psychiatry. 2014 Feb;19(2):145-6. doi: 10.1038/mp.2012.196. Epub 2013 Jan 22. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | change in 10-point visual analog scale of carving | The score of scale is from 0 to 10. 0 represents no carving for drug, 10 means the greatest degree of carving for drug. | Baseline (preoperative),3 months,6 months, 12 months | |
| Primary | change in Obsessive Compulsive Drug Use Scale | Baseline (preoperative),3 months,6 months, 12 months | ||
| Secondary | Side Effect | Baseline(preoperative),3 months, 6 months, 12months | ||
| Secondary | Change in the Hamilton Anxiety Scale | Baseline(preoperative),3 months, 6 months, 12months | ||
| Secondary | Change in the Hamilton Depression Scale | Baseline(preoperative),3 months, 6 months, 12 months | ||
| Secondary | Change in the Quality of Life Assessment (SF-36) | Baseline(preoperative),3 months, 6 months, 12 months | ||
| Secondary | Change in World Health Organization Quality of Life-BREF(WHO-BREF) | Baseline(preoperative),3 months,6 months, 12 months | ||
| Secondary | Chang in Pittsburgh Sleep Quality Index | Baseline(preoperative),3 months,6 months, 12 months | ||
| Secondary | Neuropsychological measures(Scores of cognitive battery) | Baseline(preoperative),6 months,12 months | ||
| Secondary | Change in Fagerstrom Test of Nicotine Dependence(FTND) | Baseline(preoperative),3 months,6 months, 12 months |