Deep Brain Stimulation of Nucleus Accumbens for Opioid Relapse Prevention

January 31, 2018 updated by: Tang-Du Hospital

Deep Brain Stimulation of Nucleus Accumbens for Opioid Relapse Prevention:A Multicenter Randomized Double-Blind Sham-stimulation Controlled Clinical Trial

Nucleus accumbens plays important roles in the process of opiate addiction and initial of relapse after detoxification.According to the single-centered preliminary open-labeled prospective trial results, the investigators hypothesize that bilateral stimulation of the NAc will effectively reduce the relapse of the opiate dependence.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100191
        • Recruiting
        • National Institute on Drug Dependence, Peking University
        • Contact:
        • Contact:
          • Jie Shi, M.D.
          • Phone Number: +86 13910710407
        • Principal Investigator:
          • Lin Lu, M.D.
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Recruiting
        • Nanfang Hospital Southern Medical University
        • Contact:
          • Kaijun Yang, M.D.
          • Phone Number: +86 13380082493
        • Sub-Investigator:
          • Kaijun Yang, M.D.
    • Shaanxi
      • Xi'an, Shaanxi, China, 710038
        • Recruiting
        • Department of Neurosurgery, Tangdu Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Guodong Gao, M.D.
        • Sub-Investigator:
          • Xuelian Wang, M.D.
    • Shanghai
      • Shanghai, Shanghai, China, 200020
        • Recruiting
        • Ruijin Hospital
        • Contact:
        • Principal Investigator:
          • Bomin Sun, M.D.
    • Si Chuan
      • Chengdu, Si Chuan, China, 610041
        • Recruiting
        • West China Hospital
        • Contact:
          • Wei Wang, M.D.
          • Phone Number: +86 13808170699

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years old < Age < 50 years old

  • Moderate to severe opiates abuse disorders (fulfilled diagnostic-criteria according to DSM-5)

    1. History of opiates abuse no less than 3 years
    2. Failure of at least three addiction treatments ( in hospital or compulsive rehabilitation）, among which failure of methadone maintenance treatment must be met
    3. completion of detoxification ( Negative urine test for morphine, methamphetamine, ketamine and buprenorphine)
  • Free patient's decision/informed Consent (existing comprehensive ability in meaning, methodology and execution of the study and ability of acceptance, known the benefit and risk of the treatment)

Exclusion Criteria:

  • Clinical relevant psychiatric comorbidity (schizophrenic psychoses, bipolar affective diseases, severe personality disorder)
  • Contraindications of a MRI-examination, e.g. implanted cardiac pacemaker/heart defibrillator
  • Abuse of other type of drugs
  • severe cognitive impairments
  • Enrollment in other clinical trials
  • Stereotactic respectively neurosurgical intervention in the past
  • Contraindications of a stereotactic operation, e.g. increased bleeding-disposition, cerebrovascular diseases (e.g. arteriovenous malfunction, aneurysms, systemic vascular diseases)
  • Serious and instable organic diseases (e.g. instable coronal heart disease)
  • tested positively for HIV
  • pregnancy and/or lactation
  • Severe disorders for coagulation and liver function
  • Epilepsy or other severe brain trauma or neurological impairments

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Postoperative immediate Deep brain stimulation
The addicts undergone the deep brain stimulation while the stimulation (Suzhou Sceneray® DBS System) was turned on 1-2 weeks postoperatively.
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.
Sham Comparator: Postoperative delayed Deep brain stimulation
The addicts undergone the deep brain stimulation while the stimulation (Suzhou Sceneray® DBS System) was off until 25 months postoperatively, during which the following up was kept, then the the stimulation was turned on 25 months postoperatively.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The abstinent rate at 25 weeks after DBS stimulation on （Urine Tests）
Time Frame: At 25 weeks after DBS stimulation on
If the participants or their families report no less than 2 times of the drug use in each of two consecutive weeks, or the consecutive 2 times of urine tests showed positive, or lost of follow-up, the case was defined as relapse
At 25 weeks after DBS stimulation on

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The total days of abstinence for participants
Time Frame: Baseline (preoperative), 4 weeks, 12 weeks, 25 week after DBS stimulation on
The total days of abstinence for participants
Baseline (preoperative), 4 weeks, 12 weeks, 25 week after DBS stimulation on
The longest duration for sustained abstinence for participants
Time Frame: Baseline (preoperative), 4 weeks, 12 weeks, 25 week after DBS stimulation on
The longest duration for sustained abstinence for participants
Baseline (preoperative), 4 weeks, 12 weeks, 25 week after DBS stimulation on
Visual analog scale (VAS) craving score for opioid drugs
Time Frame: Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on
Ranging from 0-10,with 0 indicates no craving while 10 indicates extreme craving
Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on
Body weight for participants
Time Frame: Baseline (preoperative), 4 weeks, 12 weeks, 25 week after DBS stimulation on
Body weight for participants
Baseline (preoperative), 4 weeks, 12 weeks, 25 week after DBS stimulation on
Hamilton Depression Scale（HAMD-17)
Time Frame: Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on
17 items,Total scores<7: normal;7<Total scores<17:possible depression;17<Total scores<24:definite depression;Total score>24: severe depression
Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on
Scaling for Opiate withdrawal symptoms
Time Frame: Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on
There were 19 items for rating 19 withdrawl symptoms, with 0 indicating none and 4 indicating most severe, the total scores are obtained by summary for scores of each items, ranging from 0-76, the higher the total scores indicating the worsen opiate withdrawl symptoms.
Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on
The evaluation on MATRICS-test
Time Frame: Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on
Software system constructed by MATRICS company, which was used for evaluate the cognitive function of the participants
Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on
The rate of positive urine test results
Time Frame: Baseline (preoperative), 4 weeks, 12 weeks, 25 week after DBS stimulation on
times of positive urine test/ total times of urine test
Baseline (preoperative), 4 weeks, 12 weeks, 25 week after DBS stimulation on
Hamilton Anxiety Scale (HAMA)
Time Frame: Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on
14 items, Total scores<6: normal;7<Total scores<14:possible anxiety;14<Total scores<21:definite anxiety;Total score>21: severe anxiety
Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on
Pittsburgh sleep quality index(PSQI)
Time Frame: Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on
Scaling for evaluating the sleep quality, the higher total scores indicating the more difficulties on sleep, thus the higher total scores indicating the worsen sleep quality
Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on
Fagerstrom Test Nicotine Dependence assessment (FTND)
Time Frame: Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on
Scaling for Nicotine Dependence: The higher of scores indicating higher lever of Nicotine Dependence
Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on
Social Disability Screening Schedule (SDSS)
Time Frame: Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on
Scaling for Social Disability with 10 items, the higher total scores indicating the much severe social disability
Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on
Activity of Daily Living Scale (ADL)
Time Frame: Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on
Consists of Physical Self-maintenance Scale and Instrumental Activities of Daily Living Scale, ranging from 0-56, total scores <14, normal; total score >14, ADL dysfunction
Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on
36-Item Short Form Health Survey (SF-36)
Time Frame: Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on
Scaling for Quality of life with 8 subscales, the higher total scores indicating the better quality of life.
Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tang-Du Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Peking University First Hospital
West China Hospital
Nanfang Hospital of Southern Medical University
Ruijin Hospital
National Institute on Drug Dependence, Peking University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Guodong Gao, M.D., Department of Neurosurgery, Tangdu Hospital
  • Principal Investigator: Lin Lu, M.D., National Institute on Drug Dependence, Peking University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 6, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 30, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 17, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 31, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 7, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 7, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 31, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NAcDBSORP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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