NCT03424616

Brief Summary

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.

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
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2018

Typical duration for not_applicable

Geographic Reach
1 country

5 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

January 17, 2018

Completed
20 days until next milestone

Study Start

First participant enrolled

February 6, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 7, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2020

Completed
Last Updated

February 7, 2018

Status Verified

January 1, 2018

Enrollment Period

2 years

First QC Date

January 17, 2018

Last Update Submit

January 31, 2018

Conditions

Addiction

Keywords

Opiate dependenceDeep brain stimulationNucleus accumbens

Outcome Measures

Primary Outcomes (1)

  • The abstinent rate at 25 weeks after DBS stimulation on （Urine Tests）

    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 Outcomes (14)

  • 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

    Baseline (preoperative), 4 weeks, 12 weeks, 25 week after DBS stimulation on

  • Visual analog scale (VAS) craving score for opioid drugs

    Baseline (preoperative), 1week, 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)

    Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on

  • +9 more secondary outcomes

Study Arms (2)

Postoperative immediate Deep brain stimulation

EXPERIMENTAL

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

Postoperative delayed Deep brain stimulation

SHAM COMPARATOR

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

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.

Postoperative delayed Deep brain stimulationPostoperative immediate Deep brain stimulation

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • years old \< Age \< 50 years old
  • Moderate to severe opiates abuse disorders (fulfilled diagnostic-criteria according to DSM-5)
  • History of opiates abuse no less than 3 years
  • Failure of at least three addiction treatments ( in hospital or compulsive rehabilitation）, among which failure of methadone maintenance treatment must be met
  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

National Institute on Drug Dependence, Peking University

Beijing, Beijing Municipality, 100191, China

RECRUITING

Nanfang Hospital Southern Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

Department of neurosurgery, Tangdu Hospital

Xi'an, Shaanxi, 710038, China

RECRUITING

Ruijin Hospital

Shanghai, Shanghai Municipality, 200020, China

RECRUITING

West China Hospital

Chengdu, Sichuan, 610041, China

RECRUITING

Related Publications (1)

  • Qu L, Ge S, Li N, Wang W, Yang K, Wu P, Wang X, Shi J. Clinical evaluation of deep brain stimulation of nucleus accumbens/anterior limb of internal capsule for opioid relapse prevention: protocol of a multicentre, prospective and double-blinded study. BMJ Open. 2019 Feb 13;9(2):e023516. doi: 10.1136/bmjopen-2018-023516.

    PMID: 30765398DERIVED

MeSH Terms

Conditions

Behavior, AddictiveOpioid-Related Disorders

Condition Hierarchy (Ancestors)

Compulsive BehaviorImpulsive BehaviorBehaviorNarcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Guodong Gao, M.D.

    Department of neurosurgery, Tangdu Hospital

    PRINCIPAL INVESTIGATOR

  • Lin Lu, M.D.

    National Institute on Drug Dependence, Peking University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Guodong Gao, M.D.

CONTACT

+86 29 84717556gguodong@fmmu.edu.cn

Lin Lu, M.D.

CONTACT

+86 13801027748linlu@bjmu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Stagger-on design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2018

First Posted

February 7, 2018

Study Start

February 6, 2018

Primary Completion

January 30, 2020

Study Completion

January 30, 2020

Last Updated

February 7, 2018

Record last verified: 2018-01

Locations

CN(5)