Clinical trial NCT02440152: The Effectiveness of Deep Brain Stimulation for Opioid Relapse Prevention
Official title: The Effectiveness of Deep Brain Stimulation for Opioid Relapse Prevention
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Opiate Addiction
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
Collaborators: name: Suzhou Sceneray Medical Co. , Ltd
name: Shanghai Mental Health Center
name: Institution of Neuroscience
name: National Natural Science Foundation of China
First posted: 2015-05-12
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The nucleus accumbens (NAcc) has a significant role in the process of opiate addiction and the initiation of relapse after detoxification. There is evidence that deep brain stimulation (DBS) of the NAcc exerts a positive effect on individuals with severe heroin addiction via inhibitory action .

The investigators hypothesise that bilateral stimulation of the NAcc will significantly reduce withdrawal symptoms and thus enable the patients to substantially decrease their Levomethadone usage.


Eligibility criteria: Inclusion Criteria:

* Proficiency in Mandarin language
* Long lasting heroin addiction (determined by diagnostic-criteria in Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition)
* Duration longer than 6 months
* A lack of response to long-term treatment
* Capacity to provide informed consent (understanding of the study purpose and methods)
* Substitution methadone treatment at a constant dose within three months prior to inclusion.

Exclusion Criteria:

* Clinical relevant psychiatric comorbidity (schizophrenic psychoses, bipolar affective diseases with psychotic symptoms)(MINI 6.0)
* 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)
* Serious and unstable organic diseases (e.g. unstable coronal heart disease)
* HIV positive
* Pregnancy and/or lactation

Primary outcomes:
measure: Weekly urine tests
timeFrame: Baseline (preoperative), 3 months, 6 months, 9 months, 12 months, 18 months, 24 months
Secondary outcomes:
measure: Change in 10-point visual analog scale (VAS) craving score for opioid drugs
timeFrame: Baseline (preoperative), 3 months, 6 months, 9 months, 12 months, 18 months, 24 months
measure: Change in Hamilton Anxiety Scale
timeFrame: Baseline (preoperative), 3 months, 6 months, 9 months, 12 months, 18 months, 24 months
measure: Change in Hamilton Depression Scale-17
timeFrame: Baseline (preoperative), 3 months, 6 months, 9 months, 12 months, 18 months, 24 months
measure: Change in SF-36 assessment
timeFrame: Baseline (preoperative), 6 months, 12 month, 24 month
measure: Neuropsychological measures（Scores of Iowa gambling task and Model task）
timeFrame: Baseline (preoperative), Intraoperative,6 months,12month,24month
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai RuiJin Hospital Psychitric Department
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Mental Health Center
state: Shanghai
Study officials:
affiliation: Ruijin Hospital
name: Bomin Sun, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Luigjes J, van den Brink W, Feenstra M, van den Munckhof P, Schuurman PR, Schippers R, Mazaheri A, De Vries TJ, Denys D. Deep brain stimulation in addiction: a review of potential brain targets. Mol Psychiatry. 2012 Jun;17(6):572-83. doi: 10.1038/mp.2011.114. Epub 2011 Sep 20.
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.
citation: Valencia-Alfonso CE, Luigjes J, Smolders R, Cohen MX, Levar N, Mazaheri A, van den Munckhof P, Schuurman PR, van den Brink W, Denys D. Effective deep brain stimulation in heroin addiction: a case report with complementary intracranial electroencephalogram. Biol Psychiatry. 2012 Apr 15;71(8):e35-7. doi: 10.1016/j.biopsych.2011.12.013. Epub 2012 Jan 26. No abstract available.
citation: Zhou H, Xu J, Jiang J. Deep brain stimulation of nucleus accumbens on heroin-seeking behaviors: a case report. Biol Psychiatry. 2011 Jun 1;69(11):e41-2. doi: 10.1016/j.biopsych.2011.02.012. Epub 2011 Apr 13. No abstract available.