NCT01245075Unknown早期 1 期
Deep Brain Stimulation of the Nucleus Accumbens as a Novel Treatment in Severe Opioid Addiction
Jens Kuhn2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2011年1月最近更新:
适应症
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Reduction of Levomethadone
研究概览
简要总结
The main objective of this study is to assess the efficacy of bilateral deep brain stimulation (DBS) of the Nucleus accumbens (NAc) as a novel treatment in severe opioid addiction. The included patients have been treated so far with a substitute in form of methadone.
Our hypothesis is that bilateral DBS of the NAc will significantly reduce the craving for heroin and thus enable the patients to decrease their Levomethadone-dosage substantially.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
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
- •Proficiency in the German language
- •Long lasting heroin addiction (fulfilled diagnostic-criteria according to DSM-IV,ICD-10)
- •At least one detoxication-treatment without a long-term period of abstinence has already taken place
- •Long-term inpatient treatment to support abstinence have occurred
- •Free patient's decision / Informed Consent (existing comprehensive ability in meaning, methodology and execution of the study and ability of acceptance)
- •If prior medication, stable dosage of psychopharmacological drugs over the last three months, which shall, after checking be retained during the study
- •Substitution treatment with constant dose within the last three months before study inclusion
排除标准
- •Hospitalization by PsychKG
- •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
- •Verbal IQ < 85 (evaluated with the German Mehrfachauswahl-Intelligenz-Test (MWT-A/B))
- •Stereotactic respectively neurosurgical intervention in the past
- •Neoplastical neurological diseases
- •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
Reduction of Levomethadone
时间窗: seven month
Reduction of the dosage of the substitute (in detail Levomethadone) comparing baseline and the particular ward rounds during and at the end of the crossover-design.
次要结局
- Drug seeking, goal directed behavior, Craving, Psychological components Laboratory parameters in the urine (parallel consumption of other drugs)(seven month)
研究者
Jens Kuhn
Prof. Dr.
University of Cologne
研究点 (2)
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