NCT02282072

Brief Summary

The purpose of this study is to verify efficacy and safety of a bilateral deep brain stimulation (DBS) of the Nucleus accumbens (NAc) as a treatment option for severe opioid addiction.

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
20

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Dec 2016

Geographic Reach
1 country

1 active site

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

September 26, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 4, 2014

Completed
2.1 years until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

October 14, 2016

Status Verified

August 1, 2016

Enrollment Period

1.8 years

First QC Date

September 26, 2014

Last Update Submit

October 13, 2016

Conditions

Opioid Addiction

Outcome Measures

Primary Outcomes (1)

  • Schedule for the Assessment of Negative Symptoms (SANS)

    6 month

Secondary Outcomes (3)

  • Chronic Hunger Scale

    6 month

  • Beck Depression Inventory

    6 month

  • Buss & Perry Aggression Questionnaire

    6 month

Study Arms (2)

Deep Brain Stimulation

ACTIVE COMPARATOR

Stimulator is ON

Device: Deep brain stimulation：PINS Stimulation System

Placebo

SHAM COMPARATOR

Stimulator is OFF

Device: Deep brain stimulation：PINS Stimulation System

Interventions

Deep brain stimulation：PINS Stimulation SystemDEVICE
Also known as: Non-rechargeable Implanted device
Deep Brain StimulationPlacebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 18 years old.
  • In accordance with the diagnostic standards of DSM-IV \& ICD-10 for addicted and DSM-IV for abstinence.
  • Qualitative urine detection for opioids showing positive result.
  • Cleared for 8 to 36 hours after their last drug taking.
  • Fully understood and signed on informed consent.

You may not qualify if:

  • Person with consciousness disorder on opioid abstinence, seriously aggressive, heavily dehydrated and intending to commit suicide.
  • Patients with serious liver and kidney dysfunction, pulmonary decompensation, or complicated with serious damage in other systems.
  • Patients with serious infectious disease.
  • Patients with history of serious neurological or psychiatrical diseases.
  • Person with history of HIV infection or serious malnutrition.
  • Dependent upon and addicted to multiple drugs.
  • Attended some other drug trials within one month.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 310000, China

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Li Luming, PhD

    Tsinghua University

    STUDY CHAIR

Central Study Contacts

Jia Fumin, PhD

CONTACT

+86 010-59361265pins_medical@163.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2014

First Posted

November 4, 2014

Study Start

December 1, 2016

Primary Completion

September 1, 2018

Study Completion

December 1, 2018

Last Updated

October 14, 2016

Record last verified: 2016-08

Locations

CN(1)