NCT02440152

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
6

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2017

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 12, 2015

Completed
1.7 years until next milestone

Study Start

First participant enrolled

February 1, 2017

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

June 29, 2017

Status Verified

June 1, 2017

Enrollment Period

2.4 years

First QC Date

March 29, 2015

Last Update Submit

June 28, 2017

Conditions

Opiate Addiction

Outcome Measures

Primary Outcomes (1)

  • Weekly urine tests

    Baseline (preoperative), 3 months, 6 months, 9 months, 12 months, 18 months, 24 months

Secondary Outcomes (5)

  • 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

  • Change in Hamilton Anxiety Scale

    Baseline (preoperative), 3 months, 6 months, 9 months, 12 months, 18 months, 24 months

  • Change in Hamilton Depression Scale-17

    Baseline (preoperative), 3 months, 6 months, 9 months, 12 months, 18 months, 24 months

  • Change in SF-36 assessment

    Baseline (preoperative), 6 months, 12 month, 24 month

  • Neuropsychological measures（Scores of Iowa gambling task and Model task）

    Baseline (preoperative), Intraoperative,6 months,12month,24month

Study Arms (1)

Deep brain stimulation

EXPERIMENTAL
Device: Suzhou Sceneray® DBS System

Interventions

Suzhou Sceneray® DBS SystemDEVICE

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).

Deep brain stimulation

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Shanghai RuiJin Hospital Psychitric Department

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

Related Publications (4)

  • 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.

    PMID: 21931318BACKGROUND

  • 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.

    PMID: 23337942RESULT

  • 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.

    PMID: 22281120RESULT

  • 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.

    PMID: 21489407RESULT

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Bomin Sun, MD, PhD

    Ruijin Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

ChenCheng Zhang, MD

CONTACT

i@cczhang.org

Kristina Zeljic, MSc

CONTACT

zeljickristina@ion.ac.cn

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Functional Neurosurgery

Study Record Dates

First Submitted

March 29, 2015

First Posted

May 12, 2015

Study Start

February 1, 2017

Primary Completion

July 1, 2019

Study Completion

July 1, 2021

Last Updated

June 29, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)