Slow continuous subcutaneous flumazenil infusion for benzodiazepine dependence: a pilot study

Radboud University Medical Centre, department of Psychiatry0 个研究点开始时间: 2015年10月5日最近更新: 2016年4月11日

适应症

试验速览

暂无简介。

•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.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 30
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•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;

发起方

Radboud University Medical Centre, department of Psychiatry