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AddictionNCT03424616

Deep Brain Stimulation of Nucleus Accumbens for Opioid Relapse Prevention

A study testing Suzhou Sceneray® DBS System in people with Addiction, run by Tang-Du Hospital at 5 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Addiction
What is being tested?
Suzhou Sceneray® DBS System
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
5 sitesChina
Study dates
6 Feb 2018to 30 Jan 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 18 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)

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

5 sites in 1 country.

Guodong Gao, M.D. contact

+86 29 84717556

gguodong@fmmu.edu.cn

Lin Lu, M.D. contact

+86 13801027748

linlu@bjmu.edu.cn

5 sites in 1 country

China5 sites, 5 recruiting

  • National Institute on Drug Dependence, Peking University

    Beijing, Beijing Municipality, 100191

    Lin Lu, M.D., +86 13801027748, linlu@bjmu.edu.cn

    Jie Shi, M.D., +86 13910710407

    Recruiting

  • West China Hospital

    Chengdu, Sichuan, 610041

    Wei Wang, M.D., +86 13808170699

    Wei Wang, M.D.

    Recruiting

  • Nanfang Hospital Southern Medical University

    Guangzhou, Guangdong, 510515

    Kaijun Yang, M.D., +86 13380082493

    Kaijun Yang, M.D.

    Recruiting

  • Ruijin Hospital

    Shanghai, Shanghai Municipality, 200020

    Bomin Sun, M.D., +86 13817777401, bominsun@sh163a.sta.net.cn

    Bomin Sun, M.D.

    Recruiting

  • Department of neurosurgery, Tangdu Hospital

    Xi'an, Shaanxi, 710038

    Guodong Gao, M.D., +86 29 84717556, gguodong@fmmu.edu.cn

    Xuelian Wang, M.D., +86 29 84777284, wxlian@fmmu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: 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.

Conditions
Addiction
Being tested
Suzhou Sceneray® DBS System
Keywords
Opiate dependence, Deep brain stimulation, Nucleus accumbens
Medical subject headings
Behavior, Addictive, Opioid-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT03424616
Study groupRoleWhat they receive
Postoperative immediate Deep brain stimulationExperimentalThe addicts undergone the deep brain stimulation while the stimulation (Suzhou Sceneray® DBS System) was turned on 1-2 weeks postoperatively.
Receives: Device: Suzhou Sceneray® DBS System
Postoperative delayed Deep brain stimulationSham comparatorThe 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.
Receives: Device: Suzhou Sceneray® DBS System

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: At 25 weeks after DBS stimulation on

Secondary outcomes (14)

  1. The total days of abstinence for participants

    The total days of abstinence for participants

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

  2. The longest duration for sustained abstinence for participants

    The longest duration for sustained abstinence for participants

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

  3. Visual analog scale (VAS) craving score for opioid drugs

    Ranging from 0-10,with 0 indicates no craving while 10 indicates extreme craving

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

  4. Body weight for participants

    Body weight for participants

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

  5. Hamilton Depression Scale（HAMD-17)

    17 items,Total scores<7: normal;7<Total scores<17:possible depression;17<Total scores<24:definite depression;Total score>24: severe depression

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

  6. Scaling for Opiate withdrawal symptoms

    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.

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

  7. The evaluation on MATRICS-test

    Software system constructed by MATRICS company, which was used for evaluate the cognitive function of the participants

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

  8. The rate of positive urine test results

    times of positive urine test/ total times of urine test

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

  9. Hamilton Anxiety Scale (HAMA)

    14 items, Total scores<6: normal;7<Total scores<14:possible anxiety;14<Total scores<21:definite anxiety;Total score>21: severe anxiety

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

  10. Pittsburgh sleep quality index(PSQI)

    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

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

  11. Fagerstrom Test Nicotine Dependence assessment (FTND)

    Scaling for Nicotine Dependence: The higher of scores indicating higher lever of Nicotine Dependence

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

  12. Social Disability Screening Schedule (SDSS)

    Scaling for Social Disability with 10 items, the higher total scores indicating the much severe social disability

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

  13. Activity of Daily Living Scale (ADL)

    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

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

  14. 36-Item Short Form Health Survey (SF-36)

    Scaling for Quality of life with 8 subscales, the higher total scores indicating the better quality of life.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2018
  2. Study start6 Feb 2018 (estimated)
  3. Primary completion30 Jan 2020 (estimated)
  4. Study completion30 Jan 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Stagger-on design
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03424616
Sponsor's protocol ID
NAcDBSORP
Status last verified
Jan 2018
First submitted
17 Jan 2018
Last updated
7 Feb 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 30765398

Questions about this trial

What is this clinical trial studying?

A study testing Suzhou Sceneray® DBS System in people with Addiction, run by Tang-Du Hospital at 5 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Guodong Gao, M.D. (+86 29 84717556, gguodong@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The abstinent rate at 25 weeks after DBS stimulation on （Urine Tests） (time frame: At 25 weeks after DBS stimulation on). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03424616, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2018.

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