NCT01274988Unknown不适用
Deep Brain Stimulation of Nucleus Accumbens as a New Treatment to Prevent Relapse for Opiate Addicts
Tang-Du Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2011年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Treatment retention
研究概览
简要总结
Nucleus accumbens plays important roles in the process of opiate addiction and initial of relapse after detoxification, deep brain stimulation of nucleus accumbens will inhibit its activity and thus to effectively prevent the relapse of the opiate dependence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years old
- •Long lasting heroin addiction (fulfilled diagnostic-criteria according to ICD-10)
- •At least three detoxication-treatments without a long-term period of abstinence has already taken place
- •Long-term inpatient treatment to support abstinence have occurred
- •completion of detoxification treatment preoperatively with no somatic symptoms of withdrawal
- •negative morphine urinalysis and naloxone tests
- •Free patient's decision/informed Consent (existing comprehensive ability in meaning, methodology and execution of the study and ability of acceptance)
排除标准
- •Clinical relevant psychiatric comorbidity (schizophrenic psychoses, bipolar affective diseases, severe personality disorder)
- •Contraindications of a MRI-examination, e.g. implanted cardiac pacemaker/heart defibrillator
- •Current and in the last six months existent paranoid-hallucinated symptomatology
- •Foreign aggressiveness in the last six months
- •Stereotactic respectively neurosurgical intervention in the past
- •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
结局指标
主要结局
Treatment retention
时间窗: 12 months
Opiate abstinent time by self-reports and monthly urinalysis for the patients undergo the deep brain stimulation of nucleus accumbens,treatment retention time for the methadone maintenance treatment patients
次要结局
- Evaluation of quality of life(Baseline, 3 month, 6 month and 12 month follow-up assessments)
- Change in two static positron emission tomography(PET) images study(Baseline and 6month follow-up)
- Change of participants' craving for opioid drugs(Baseline, 3 month, 6 month and 12month follow-up assessments)
- Change in Addiction Severity Index (ASI lite) composite scores(Baseline, 3 month, 6 month and 12month follow-up assessments)
- Psychological evaluation(Baseline, 3 month, 6 month and 12month follow-up assessments)
- Personality evaluation(Baseline, 3 month, 6 month and 12month follow-up assessments)
- Cognitive evaluation(Baseline, 3 month, 6 month and 12month follow-up assessments)
研究者
Guodong Gao
Department of Neurosurgery
Tang-Du Hospital
研究点 (1)
Loading locations...
相似试验
Unknown
不适用
Deep Brain Stimulation of Nucleus Accumbens for Opioid Relapse PreventionAddictionNCT03424616Tang-Du Hospital60
Unknown
2 期
The Effectiveness of Deep Brain Stimulation for Opioid Relapse PreventionOpiate AddictionNCT02440152Ruijin Hospital6
Unknown
不适用
Deep Brain Stimulation of NAc/ALIC to Prevent Treatment-Refractory Obsessive Compulsive DisorderObsessive Compulsive DisorderNCT02601677Tang-Du Hospital10
招募中
不适用
fMRI and Opioid AbstinenceNCT06651333Yale University240
进行中（未招募）
1 期
Deep Brain Stimulation (DBS) for Methamphetamine Use DisorderMethamphetamine Use DisorderNCT05558358University of Colorado, Denver2