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

Primary Purpose

Addiction Opiate

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Bilateral surgical implantation of DBS system to Nucleus Accumbens

About this trial

This is an interventional treatment trial for Addiction Opiate focused on measuring Nucleus Accumbens, Deep brain stimulation, Methadone

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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);

Exclusion Criteria:

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;
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;

Sites / Locations

Shanghai Ruijin Hospital Functional NeurosurgeryRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DBS

Arm Description

All subjects will undergo bilateral surgical implantation of DBS system in the Nucleus Accumbens. The DBS system will be active at two days after surgery.

Outcomes

Primary Outcome Measures

Changes in Methadone dose

The volume of daily methadone the patients used.

Secondary Outcome Measures

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

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

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.

Monitoring of Side Effects Scale (MOSES)

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

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).

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.

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.

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

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

Fagerstrom Test for Nicotine Dependence assessment (FTND)

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

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.

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.

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.

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).

Work and Social Adjustment Scale(WSAS)

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

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.

Brain activity

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

Full Information

NCT ID

NCT03952455

First Posted

May 14, 2019

Last Updated

January 7, 2020

Sponsor

Ruijin Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03952455

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2019

Overall Recruitment Status

Unknown status

Study Start Date

May 13, 2019 (Actual)

Primary Completion Date

June 1, 2021 (Anticipated)

Study Completion Date

June 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ruijin Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Addiction Opiate

Keywords

Nucleus Accumbens, Deep brain stimulation, Methadone

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

DBS

Arm Type

Experimental

Arm Description

All subjects will undergo bilateral surgical implantation of DBS system in the Nucleus Accumbens. The DBS system will be active at two days after surgery.

Intervention Type

Procedure

Intervention Name(s)

Bilateral surgical implantation of DBS system to Nucleus Accumbens

Intervention Description

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).

Primary Outcome Measure Information:

Title

Changes in Methadone dose

Description

The volume of daily methadone the patients used.

Time Frame

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

Secondary Outcome Measure Information:

Title

Hamilton Depression Scale(HAMD-17)

Description

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

Time Frame

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

Title

Hamilton Anxiety Scale (HAMA)

Description

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

Time Frame

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

Title

Young Manic Rating Scale (YMRS)

Description

Time Frame

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

Title

Monitoring of Side Effects Scale (MOSES)

Description

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

Time Frame

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

Title

Changes in Subjective Opiate Withdrawal Scale(SOWS)

Description

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).

Time Frame

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

Title

Obsessive compulsive drug use scale(OCDUS)

Description

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.

Time Frame

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

Title

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

Description

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

Time Frame

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

Title

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

Description

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

Time Frame

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

Title

Fagerstrom Test for Nicotine Dependence assessment (FTND)

Description

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

Time Frame