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The Effectiveness of Deep Brain Stimulation for Opioid Relapse Prevention

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2017 by Bomin Sun, Ruijin Hospital
Sponsor:
Collaborators:
Suzhou Sceneray Medical Co. , Ltd
Shanghai Mental Health Center
Institution of Neuroscience
National Natural Science Foundation of China
Information provided by (Responsible Party):
Bomin Sun, Ruijin Hospital
ClinicalTrials.gov Identifier:
NCT02440152
First received: March 29, 2015
Last updated: June 28, 2017
Last verified: June 2017
  Purpose

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.


Condition Intervention Phase
Opiate Addiction Device: Suzhou Sceneray® DBS System Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effectiveness of Deep Brain Stimulation for Opioid Relapse Prevention

Further study details as provided by Bomin Sun, Ruijin Hospital:

Primary Outcome Measures:
  • Weekly urine tests [ Time Frame: Baseline (preoperative), 3 months, 6 months, 9 months, 12 months, 18 months, 24 months ]

Secondary Outcome Measures:
  • Change in 10-point visual analog scale (VAS) craving score for opioid drugs [ Time Frame: Baseline (preoperative), 3 months, 6 months, 9 months, 12 months, 18 months, 24 months ]
  • Change in Hamilton Anxiety Scale [ Time Frame: Baseline (preoperative), 3 months, 6 months, 9 months, 12 months, 18 months, 24 months ]
  • Change in Hamilton Depression Scale-17 [ Time Frame: Baseline (preoperative), 3 months, 6 months, 9 months, 12 months, 18 months, 24 months ]
  • Change in SF-36 assessment [ Time Frame: Baseline (preoperative), 6 months, 12 month, 24 month ]
  • Neuropsychological measures(Scores of Iowa gambling task and Model task) [ Time Frame: Baseline (preoperative), Intraoperative,6 months,12month,24month ]

Estimated Enrollment: 6
Actual Study Start Date: February 1, 2017
Estimated Study Completion Date: July 2021
Estimated Primary Completion Date: July 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Deep brain stimulation 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).

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02440152

Contacts
Contact: ChenCheng Zhang, MD i@cczhang.org
Contact: Kristina Zeljic, MSc zeljickristina@ion.ac.cn

Locations
China, Shanghai
Shanghai RuiJin Hospital Psychitric Department Recruiting
Shanghai, Shanghai, China, 200025
Contact: Haiyan Jin, MD       hyjin603@163.com   
Shanghai Mental Health Center Recruiting
Shanghai, Shanghai, China, 200030
Contact: Jiang Du, MD       dujiangdou@163.com   
Contact: Min Zhao, MD,PhD       drzhaomin@sh163.net   
Sponsors and Collaborators
Ruijin Hospital
Suzhou Sceneray Medical Co. , Ltd
Shanghai Mental Health Center
Institution of Neuroscience
National Natural Science Foundation of China
Investigators
Principal Investigator: Bomin Sun, MD, PhD Ruijin Hospital
  More Information

Publications:
Responsible Party: Bomin Sun, Department of Functional Neurosurgery, Ruijin Hospital
ClinicalTrials.gov Identifier: NCT02440152     History of Changes
Other Study ID Numbers: 2014-15
Study First Received: March 29, 2015
Last Updated: June 28, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 25, 2017