ACTRN12619001013156已完成1 期
An open label study to evaluate the safety, tolerability, and pharmacokinetics of a medicinal cannabinoid oil formulation in chronic non-cancer pain patients
Zelda Therapeutics0 个研究点目标入组 9 人开始时间: 2019年7月15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
- 9
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
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 25 Years 至 65 Years（—）
- 性别
- All
入选标准
- •Chronic non-cancer pain on long term treatment (>12months) with high dose (OMEDD >60mg) opioid analgesia.
- •Willing to cease driving a motor vehicle for the duration of the study.
- •No cannabis use in the last month.
排除标准
- •Dependence on cannabis.
- •Cardiovascular disorder, epilepsy, psychosis, bipolar disorder, 1st degree relative with psychosis.
- •Dependence on alcohol, benzodiazepines, or amphetamine type stimulants.
- •Evidence of severe hepatic/renal impairment.
- •Active malignancy.
- •Females who are pregnant, lactating or not using adequate contraception.
- •Males who are not using adequate contraception.
研究者
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