Deep Brain Stimulation of the Bilateral Nucleus Accumbens for Patients With Methadone Maintenance Treatment
试验速览
- 阶段
- 不适用
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Changes in Methadone dose
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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);
排除标准
- •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;
结局指标
主要结局
Changes in Methadone dose
时间窗: Baseline (preoperative),1 month, 3 months,6 months,9 months, 12 months
The volume of daily methadone the patients used.
次要结局
- Perceived stress scale(PSS-10)(Baseline(preoperative),1 month, 3months,6months,9 months, 12 months)
- Work and Social Adjustment Scale(WSAS)(Baseline(preoperative),1 month, 3months,6months,9 months, 12 months)
- Obsessive compulsive drug use scale(OCDUS)(Baseline(preoperative),1 month, 3 months, 6 months,9 months, 12 months)
- Fagerstrom Test for Nicotine Dependence assessment (FTND)(Baseline(preoperative),1 month, 3months,6months,9 months, 12 months)
- Twenty Item Positive and Negative Affect Schedule (PANAS)(Baseline(preoperative),1 month, 3months,6months,9 months, 12 months)
- Young Manic Rating Scale (YMRS)(Baseline(preoperative),1 month, 3 months, 6 months,9 months, 12 months)
- Monitoring of Side Effects Scale (MOSES)(Baseline(preoperative),1 month, 3 months, 6 months,9 months, 12 months)
- Changes in Subjective Opiate Withdrawal Scale(SOWS)(Baseline(preoperative),1 month, 3 months, 6 months,9 months, 12 months)
- Beck depression inventory(BDI)(Baseline(preoperative),1 month, 3months,6months,9 months, 12 months)
- Cognitive performance(Baseline(preoperative),6 months,12 months)
- Hamilton Depression Scale(HAMD-17)(Baseline(preoperative),1 month, 3 months, 6 months, 9 months, 12 months)
- Hamilton Anxiety Scale (HAMA)(Baseline(preoperative),1 month, 3 months, 6 months,9 months, 12 months)
- The MOS item short from health survey (SF-36)(Baseline(preoperative),1 month, 3 months,6 months,9 months, 12 months)
- World Health Organization Quality of Life-BREF (WHO-BREF)(Baseline(preoperative),1 month, 3 months,6 months,9 months, 12 months)
- Brain activity(Baseline(preoperative), 6 months,12 months)
- Beck anxiety inventory(BAI)(Baseline(preoperative),1 month, 3months,6months,9 months, 12 months)
研究者
Bomin Sun
Director of the Department of Functional Neurosurgery
Ruijin Hospital