Clinical trial NCT03347474: Deep Brain Stimulation of Nucleus Accumbens for Methamphetamine Addiction
Official title: Deep Brain Stimulation of Nucleus Accumbens for Methamphetamine Addiction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Treatment Methamphetamine Addiction
Keywords: Bilateral Nucleus Accumbens
Methamphetamine Addiction
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2017-11-20
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All subjects will receive bilateral surgical implantation of DBS system
Primary purpose: TREATMENT

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.


Eligibility criteria: 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;

Primary outcomes:
measure: change in 10-point visual analog scale of carving
timeFrame: Baseline (preoperative),3 months,6 months, 12 months
measure: change in Obsessive Compulsive Drug Use Scale
timeFrame: Baseline (preoperative),3 months,6 months, 12 months
Secondary outcomes:
measure: Side Effect
timeFrame: Baseline（preoperative）,3 months, 6 months, 12months
measure: Change in the Hamilton Anxiety Scale
timeFrame: Baseline（preoperative）,3 months, 6 months, 12months
measure: Change in the Hamilton Depression Scale
timeFrame: Baseline（preoperative）,3 months, 6 months, 12 months
measure: Change in the Quality of Life Assessment (SF-36)
timeFrame: Baseline（preoperative）,3 months, 6 months, 12 months
measure: Change in World Health Organization Quality of Life-BREF(WHO-BREF)
timeFrame: Baseline（preoperative）,3 months,6 months, 12 months
measure: Chang in Pittsburgh Sleep Quality Index
timeFrame: Baseline（preoperative）,3 months,6 months, 12 months
measure: Neuropsychological measures(Scores of cognitive battery)
timeFrame: Baseline（preoperative）,6 months,12 months
measure: Change in Fagerstrom Test of Nicotine Dependence(FTND)
timeFrame: Baseline（preoperative）,3 months,6 months, 12 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Ruijin Hospital Functional Neurosurgery
state: Shanghai
Study officials:
References:
citation: Kuhn J, Moller M, Treppmann JF, Bartsch C, Lenartz D, Gruendler TO, Maarouf M, Brosig A, Barnikol UB, Klosterkotter 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. No abstract available.