Deep Brain Stimulation of Nucleus Accumbens for Methamphetamine Addiction

October 24, 2018 updated by: Bomin Sun, Ruijin Hospital
The main objective of this study is to assess the efficacy of bilateral deep brain stimulation (DBS) of the Nucleus Accumbens(NAc) as a novel treatment in severe methamphetamine addiction. Our hypothesis is that bilateral DBS of the NAc will significantly reduce the craving for methamphetamine.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • 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 Locations

    • Shanghai
      • Shanghai, Shanghai, China, 200025
        • Recruiting
        • Shanghai Ruijin Hospital Functional Neurosurgery

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

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • DSM-IV-TR diagnosis of Drug addiction disorder;
  • Age 18-65 years old;
  • Proficiency in Mandarin language;
  • Failure to detox more than three times;
  • Capacity to provide informed consent (understanding of the study purpose and methods);

Exclusion Criteria:

  • Multidrug abuse and formation of addiction;
  • Serious and unstable organic diseases (e.g. unstable coronal heart disease);
  • Any history of seizure disorder or hemorrhagic stroke;
  • 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);
  • HIV positive;
  • Pregnancy and/or lactation;

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Bilateral surgical implantation of DBS system to NAc
The Medtronic, PINS and SceneRay DBS device will be utilized in the present study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in 10-point visual analog scale of carving
Time Frame: Baseline (preoperative),3 months,6 months, 12 months
The score of scale is from 0 to 10. 0 represents no carving for drug, 10 means the greatest degree of carving for drug.
Baseline (preoperative),3 months,6 months, 12 months
change in Obsessive Compulsive Drug Use Scale
Time Frame: Baseline (preoperative),3 months,6 months, 12 months
Baseline (preoperative),3 months,6 months, 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Side Effect
Time Frame: Baseline(preoperative),3 months, 6 months, 12months
Baseline(preoperative),3 months, 6 months, 12months
Change in the Hamilton Anxiety Scale
Time Frame: Baseline(preoperative),3 months, 6 months, 12months
Baseline(preoperative),3 months, 6 months, 12months
Change in the Hamilton Depression Scale
Time Frame: Baseline(preoperative),3 months, 6 months, 12 months
Baseline(preoperative),3 months, 6 months, 12 months
Change in the Quality of Life Assessment (SF-36)
Time Frame: Baseline(preoperative),3 months, 6 months, 12 months
Baseline(preoperative),3 months, 6 months, 12 months
Change in World Health Organization Quality of Life-BREF(WHO-BREF)
Time Frame: Baseline(preoperative),3 months,6 months, 12 months
Baseline(preoperative),3 months,6 months, 12 months
Chang in Pittsburgh Sleep Quality Index
Time Frame: Baseline(preoperative),3 months,6 months, 12 months
Baseline(preoperative),3 months,6 months, 12 months
Neuropsychological measures(Scores of cognitive battery)
Time Frame: Baseline(preoperative),6 months,12 months
Baseline(preoperative),6 months,12 months
Change in Fagerstrom Test of Nicotine Dependence(FTND)
Time Frame: Baseline(preoperative),3 months,6 months, 12 months
Baseline(preoperative),3 months,6 months, 12 months

Collaborators and Investigators

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

Sponsor

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.

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 (ACTUAL)

September 20, 2017

Primary Completion (ANTICIPATED)

September 20, 2020

Study Completion (ANTICIPATED)

December 30, 2020

Study Registration Dates

First Submitted

September 3, 2017

First Submitted That Met QC Criteria

November 15, 2017

First Posted (ACTUAL)

November 20, 2017

Study Record Updates

Last Update Posted (ACTUAL)

October 26, 2018

Last Update Submitted That Met QC Criteria

October 24, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 2018-10-25 DBS-NAc Meth

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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