The Effectiveness of Deep Brain Stimulation for Opioid Relapse Prevention

Opiate Addiction Clinical Trial

Official title:

The Effectiveness of Deep Brain Stimulation for Opioid Relapse Prevention

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02440152
• Other study ID #: 2014-15
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: March 29, 2015
• Last updated: June 28, 2017
• Start date: February 1, 2017
• Est. completion date: July 2021

Study information

• Verified date: June 2017
• Source: Ruijin Hospital
• Contact: ChenCheng Zhang, MD
• Email: i[@]cczhang.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6
• Est. completion date: July 2021
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Opiate Addiction
• Opioid-Related Disorders

Intervention

Device:
• Suzhou Sceneray® DBS System
We plan to use the SceneRay 1242 (SceneRay, SuZhou, China) electrode with a diameter of 1.27 mm and 4 contacts. The SceneRay 1242 electrode combined with the SceneRay 1181 implantable pulse generator has the advantage of adaptive coverage area for the Ventral Capsule/Ventral Striatum, enabling simultaneous implantation in the nucleus accumbens (NAc; 2 ventral contacts) and the anterior limb of the internal capsule (ALIC; 2 dorsal contacts) with independently programmed parameters such as frequency, amplitude, and voltage; and remote and wireless programing, which allows for convenient and prompt adjustments in emergency situations. The contact length is 3.0 mm and the spacings between the ventral and dorsal contacts are 2 mm, 4 mm, and 4 mm, respectively, spanning a total length of 22.5 mm (3 + 2 + 3 + 4 + 3 + 4 + 3 mm, with 0.5 mm projecting from the electrode tip).

Locations

Country	Name	City	State
China	Shanghai Mental Health Center	Shanghai	Shanghai
China	Shanghai RuiJin Hospital Psychitric Department	Shanghai	Shanghai

Sponsors (5)

Lead Sponsor	Collaborator
Ruijin Hospital	Institution of Neuroscience, National Natural Science Foundation of China, Shanghai Mental Health Center, Suzhou Sceneray Medical Co. , Ltd

Country where clinical trial is conducted

China, 

References & Publications (4)

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):1 — View 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. Review. — View 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 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weekly urine tests		Baseline (preoperative), 3 months, 6 months, 9 months, 12 months, 18 months, 24 months
Secondary	Change in 10-point visual analog scale (VAS) craving score for opioid drugs		Baseline (preoperative), 3 months, 6 months, 9 months, 12 months, 18 months, 24 months
Secondary	Change in Hamilton Anxiety Scale		Baseline (preoperative), 3 months, 6 months, 9 months, 12 months, 18 months, 24 months
Secondary	Change in Hamilton Depression Scale-17		Baseline (preoperative), 3 months, 6 months, 9 months, 12 months, 18 months, 24 months
Secondary	Change in SF-36 assessment		Baseline (preoperative), 6 months, 12 month, 24 month
Secondary	Neuropsychological measures(Scores of Iowa gambling task and Model task)		Baseline (preoperative), Intraoperative,6 months,12month,24month