NL-OMON41934招募中2 期
Slow continuous subcutaneous flumazenil infusion for benzodiazepine dependence: a pilot study - Subcutaneous flumazenil infusion for benzodiazepine dependence
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64(—)
入选标准
- •A primary diagnosis of benzodiazepine dependence with an average daily dose of at least 30 mg of diazepam or equivalent according table 2
- •A diagnosis of benzodiazepine dependence with an average daily dose of at least 30 mg of diazepam or an equivalent with a co-morbid diagnosis of alcohol or cannabis dependence. Prior to the baseline measurement and flumazenil infusion patients must be abstinent from alcohol and cannabis for at least two months.
- •Age between 21 and 65 years.
- •Participants should master Dutch language sufficiently to provide informed consent and participate in all measurements (including self report questionnaires).
- •Motivation for and availability of a regular treatment after the detoxification procedure at a regional (addiction) care facility.
排除标准
- •History of epilepsy or IEDs on EEG or other serious neurological disorders;
- •History of a serious medical condition, including heart disease (myocardial infarction or arrhythmias), lung disease (COPD gold stage II or higher), acute liver or kidney disease (indexed by ASAT ALAT max three times the norm or increased Creatinine/Ureum);
- •Diagnosis of a current severe psychiatric disorder (psychosis, mania, severe depression);
- •Diagnosis of a primary organic sleep disorders e.g. hypersomnia, disorders of the sleep wake schedule and sleep apnoea;
- •A positive urine screening for cocaine, heroin, amphetamine, ecstasy, cannabis, opiates, buprenorphine and methadone;
研究者
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