DRKS00000315已完成1 期
Placebo controlled fMRT assessment of the effects of the cannabinoid receptor agonist dronabinol (THC) on pain associated brain activation
Klinikum der J.W.Goethe-Universität Frankfurt0 个研究点目标入组 30 人开始时间: 2010年6月22日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 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
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 50 Years（—）
- 性别
- All
入选标准
- •Healthy men and women aged 18-50 years
- •Body mass index (BMI) in the range of 18 kg/m2 and 30 kg/m2
- •unremarkable medical history, especially no heart and circulatory diseases, mental medical history
- •Healthy as determined by medical history, physical examination including vital signs and clinical laboratory test results
- •Women of childbearing age must be sterile or postmenopausal or must apply two appropriate measures of contraception (e.g. oral hormonal contraceptive plus intrauterine device) in accordance with Note 3 of the Note for guidance on non-clinical studies saftey for the Conduct of human clinical trials for pharmaceuticals (CPMP / ICH / 286 / 95 modification) (double contraception).
- •Signed informed consent after information about the benefits and risks of the trial and insurance
排除标准
- •Participation in another clinical study within the last 30 days before study
- •Simultaneous participation in another clinical trial
- •History or current evidence of abuse of any drug substance, licit or illicit, including alcohol (urine drug screen)
- •currently using of any prescription medication
- •Hypersensitivity to the active substance or any of the other ingredients
- •Epilepsy, a tendency to seizures
- •Cardiovascular diseases
- •Depression, bipolar disorder, schizophrenia and other psychiatric disorders in the medical history
- •impaired liver function
- •renal impairment
- •Pregnancy (positive pregnancy test in urine at screening” or at the beginning of the study) and breast-feeding
- •Diseases or other criteria that make an MRI measurement impossible:
- •Pacemakers
- •neurostimulator or drug pump
- •Metal parts in the body (e.g. chips, clips or staples after surgery, including: metal fragments in the body)
- •claustrophobia
研究者
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