NCT01149018Unknown不适用
A Randomized, Double-blind, Placebo-controlled Trial of Oral Tetrahydrocannabinol (∆-9-THC) in Patients With Fibromyalgia
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Meaningful change in Total score on Fibromyalgia Impact Questionnaire (FIQ)
研究概览
简要总结
The objective of the study is to evaluate the effectiveness of oral tetrahydrocannabinol in patients suffering from Fibromyalgia
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Adult (>18y.o) Patient with Fibromyalgia, diagnosed by ACR criteria
排除标准
- •Children < 18 years old
- •Patients with following psychiatric disorders:
- •Psychosis or history of acute psychosis
- •Schizophrenia
- •Bipolar disorder Patients smoking marijuana, using hashish or any other form of cannabis. Patients with history of drug abuse or illicit drug use Patients receiving chronic treatment with strong opioids (Morphine, Oxycodone, Fentanyl, Methadone, Hydromorphone, Buprenorphine, Pethidine). Weak opioids as Tramadol or Propoxyphene will be allowed.
- •Pregnant patients
研究组 & 干预措施
Tetrahydrocannabinol
Experimental
干预措施: Tetrahydrocannabinol (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Meaningful change in Total score on Fibromyalgia Impact Questionnaire (FIQ)
时间窗: 8 weeks
次要结局
- Meaningful change in Brief Pain Inventory average pain severity.(8 weeks)
研究者
研究点 (1)
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