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Addiction OpiateNCT03952455

Deep Brain Stimulation of the Bilateral Nucleus Accumbens for Patients With Methadone Maintenance Treatment

A study testing Bilateral surgical implantation of DBS system to Nucleus Accumbens in people with Addiction Opiate, run by Ruijin Hospital at 1 site 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 The sponsor has not verified this record for over two years, so it may be out of date.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

Methadone maintenance treatment (MMT) is one of the main forms of treatments for opioid dependence. Despite its effectiveness and widespread use, people will experience withdrawal if daily dose is insufficient or missed, promoting reluctance to attempt detoxification. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Addiction Opiate
What is being tested?
Bilateral surgical implantation of DBS system to Nucleus Accumbens
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteChina
Study dates
13 May 2019to 1 Jun 2021
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • MINI diagnosis of substance dependence;
  • Proficiency in Mandarin language;
  • Failure to detox more than three times;
  • Long-term methadone maintenance treatment;
  • Capacity to provide informed consent (understanding of the study purpose and methods);

Who cannot join

  • Schizophrenia(MINI diagnosis);
  • Antisocial personality disorder(MINI diagnosis);
  • Contraindications of a MRI-examination, e.g. implanted cardiac pacemaker/heart defibrillator;
  • Severe cognitive impairments(MoCA ≤ 22);
  • Enrollment in other clinical trials;
  • Stereotactic respectively neurosurgical intervention in the past;
Show all 11Show fewer
  • Contraindications of stereotactic intervention, e.g. increased bleeding disposition, cerebrovascular diseases (e.g. arteriovenous malfunction, aneurysms, systemic vascular diseases);
  • Serious or instable organic diseases (e.g. instable coronal heart disease);
  • Tested positively for HIV;
  • Pregnancy and/or lactation;
  • Epilepsy or other severe brain trauma or neurological impairments;

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting

  • Shanghai Ruijin Hospital Functional Neurosurgery

    Shanghai, Shanghai Municipality, 200025

    Chencheng Zhang, MD, +086-18217122884, i@cczhang.org

    Yingying Zhang, MSc, +086-17602137369, zhyy019@126.com

    Recruiting

Other trials in China

About this study

Methadone maintenance treatment (MMT) is one of the main forms of treatments for opioid dependence. Despite its effectiveness and widespread use, people will experience withdrawal if daily dose is insufficient or missed, promoting reluctance to attempt detoxification. In addition, methadone is a full opioid agonist which can induce respiratory depression or sedation without ceiling level, so overdose usage can be fatal. Hence, an alternative therapy is needed to completely reduce the carving for drugs and to relieve the negative affective sate caused by withdrawal.

Deep brain stimulation (DBS) is a reasonable treatment approach for addiction. Since 2009 the first case report emerged, the nucleus accumbens (NAc) is still the only brain target to be investigated in clinical case series of DBS for alcohol and heroin addiction.

This research will mainly investigate the effectiveness and safety of NAc-DBS for patients with methadone maintenance treatment. The investigators will also explore the influence of NAc-DBS on brain activity and cognition.

Being tested
Bilateral surgical implantation of DBS system to Nucleus Accumbens
Keywords
Nucleus Accumbens, Deep brain stimulation, Methadone
Medical subject headings
Opioid-Related Disorders

What participants receive

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

  • Bilateral surgical implantation of DBS system to Nucleus AccumbensProcedure or surgery

    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. The contact length is 3.0 mm and the spacings between the ventral and dorsal contacts are 2 mm, 4 mm, and 4 mm, respectively, spanning a total length of 22.5 mm (3 + 2 + 3 + 4 + 3 + 4 + 3 mm, with 0.5 mm projecting from the electrode tip).

Study groups in NCT03952455
Study groupRoleWhat they receive
DBSExperimentalAll subjects will undergo bilateral surgical implantation of DBS system in the Nucleus Accumbens. The DBS system will be active at two days after surgery.
Receives: Procedure: Bilateral surgical implantation of DBS system to Nucleus Accumbens

What is being measured

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

  1. Changes in Methadone dose

    The volume of daily methadone the patients used.

    Measured: Baseline (preoperative),1 month, 3 months,6 months,9 months, 12 months

Secondary outcomes (16)

  1. 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),1 month, 3 months, 6 months, 9 months, 12 months

  2. 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),1 month, 3 months, 6 months,9 months, 12 months

  3. Young Manic Rating Scale (YMRS)

    The Young Mania Rating Scale (YMRS) is one of the most frequently utilized rating scales to assess manic symptoms. The scale has 11 items and is based on the patient's subjective report of his or her clinical condition.

    Measured: Baseline(preoperative),1 month, 3 months, 6 months,9 months, 12 months

  4. Monitoring of Side Effects Scale (MOSES)

    To evaluate side effects. The higher score means more severity of side effects.

    Measured: Baseline(preoperative),1 month, 3 months, 6 months,9 months, 12 months

  5. Changes in Subjective Opiate Withdrawal Scale(SOWS)

    Subjective Opiate Withdrawal Scale is a 16-item self-reported scale assessing severity of opiate withdrawal. Each item is rated on a 5-point Likert scale, ranging form 0(not at all) to 4(extremely).

    Measured: Baseline(preoperative),1 month, 3 months, 6 months,9 months, 12 months

  6. Obsessive compulsive drug use scale(OCDUS)

    Obsessive compulsive drug use scale is a 13-item self-rating scale measuring opiate craving. The total score ranges from 0 to 52. The higher score indicates stronger carving.

    Measured: Baseline(preoperative),1 month, 3 months, 6 months,9 months, 12 months

  7. The MOS item short from health survey (SF-36)

    36 items. To evaluate the quality of life and the higher score indicates better quality of life.

    Measured: Baseline(preoperative),1 month, 3 months,6 months,9 months, 12 months

  8. World Health Organization Quality of Life-BREF (WHO-BREF)

    26 items. The higher score means the better quality of life.

    Measured: Baseline(preoperative),1 month, 3 months,6 months,9 months, 12 months

  9. Fagerstrom Test for Nicotine Dependence assessment (FTND)

    To evaluate Nicotine Dependence. The higher of scores indicates higher level of Nicotine Dependence

    Measured: Baseline(preoperative),1 month, 3months,6months,9 months, 12 months

  10. Beck depression inventory(BDI)

    The BDI contains 21 questions, each answer scored on a scale value of 0 to 3. 0-13: minimal depression;14-19:mild depression; 20-28:moderate depression; and 29-63:severe depression. Higher total score indicate more severe depressive symptoms.

    Measured: Baseline(preoperative),1 month, 3months,6months,9 months, 12 months

  11. Beck anxiety inventory(BAI)

    The BAI contains 21 questions, each answer scored on a scale value of 0 to 3. 0-21: mild anxiety;22-35: moderate anxiety;36-63:severe anxiety. Higher total score indicate more severe anxiety symptoms.

    Measured: Baseline(preoperative),1 month, 3months,6months,9 months, 12 months

  12. Perceived stress scale(PSS-10)

    The PSS-10 is a classic stress assessment instrument. Each item is rated on a 5-likert scale ranging form 0(never) to 4(often). Higher score indicate more severity of stress symptom.

    Measured: Baseline(preoperative),1 month, 3months,6months,9 months, 12 months

  13. Twenty Item Positive and Negative Affect Schedule (PANAS)

    The PANAS contains two subscales: positive and negative subscale. Each item is rated on a 5-likert scale ranging from 1(Not at all) to 5(severely, it bothered me a lot).

    Measured: Baseline(preoperative),1 month, 3months,6months,9 months, 12 months

  14. Work and Social Adjustment Scale(WSAS)

    Self-rated scale. The maximum score of the WSAS is 40, lower scores are better.

    Measured: Baseline(preoperative),1 month, 3months,6months,9 months, 12 months

  15. Cognitive performance

    Cognitive performance is measured by a series of tasks which include stop signal task, paired associated memory, spatial working memory, stocking of Cambridge, intra-extra dimensional set shift, Bart, Beads, Delay discounting task, model-based and model-free task, avoid-approach task, dot-probe task, drug rating task.

    Measured: Baseline(preoperative),6 months,12 months

  16. Brain activity

    PET(Positron Emission Tomography) or fMRI(functional Magnetic Resonance Imaging) are used in this study.

    Measured: Baseline(preoperative), 6 months,12 months

Timeline

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

  1. First posted16 May 2019
  2. Study start13 May 2019
  3. Primary completion1 Jun 2021 (estimated)
  4. Study completion1 Jun 2021 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03952455
Sponsor's protocol ID
2019 NAc-DBS MMT
Status last verified
May 2019
First submitted
14 May 2019
Last updated
10 Jan 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Muller UJ, Voges J, Steiner J, Galazky I, Heinze HJ, Moller M, Pisapia J, Halpern C, Caplan A, Bogerts B, Kuhn J. Deep brain stimulation of the nucleus accumbens for the treatment of addiction. Ann N Y Acad Sci. 2013 Apr;1282:119-28. doi: 10.1111/j.1749-6632.2012.06834.x. Epub 2012 Dec 10.

    PubMed 23227826

  • Kuhn J, Moller M, Treppmann JF, Bartsch C, Lenartz D, Gruendler TO, Maarouf M, Brosig A, Barnikol UB, Klosterkotter J, Sturm V. Deep brain stimulation of the nucleus accumbens and its usefulness in severe opioid addiction. Mol Psychiatry. 2014 Feb;19(2):145-6. doi: 10.1038/mp.2012.196. Epub 2013 Jan 22. No abstract available.

    PubMed 23337942

  • Muller UJ, Sturm V, Voges J, Heinze HJ, Galazky I, Buntjen L, Heldmann M, Frodl T, Steiner J, Bogerts B. Nucleus Accumbens Deep Brain Stimulation for Alcohol Addiction - Safety and Clinical Long-term Results of a Pilot Trial. Pharmacopsychiatry. 2016 Jul;49(4):170-3. doi: 10.1055/s-0042-104507. Epub 2016 May 4.

    PubMed 27145161

Questions about this trial

What is this clinical trial studying?

A study testing Bilateral surgical implantation of DBS system to Nucleus Accumbens in people with Addiction Opiate, run by Ruijin Hospital at 1 site 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 5 inclusion and 11 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 10 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. 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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in Methadone dose (time frame: Baseline (preoperative),1 month, 3 months,6 months,9 months, 12 months). 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 NCT03952455, which also lists 3 linked publications.

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 10 Jan 2020.

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