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

Ruijin Hospital12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Addiction Opiate

Interventions

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).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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;

Outcomes

Primary Outcomes

Changes in Methadone dose

The volume of daily methadone the patients used.

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

Secondary Outcomes

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

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

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

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

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.

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

Monitoring of Side Effects Scale (MOSES)

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

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).

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

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.

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

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.

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

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

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

Fagerstrom Test for Nicotine Dependence assessment (FTND)

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