NCT00046722已完成1 期
Effects of Marijuana on Neuropathic Pain in HIV-Related Peripheral Neuropathy: A Randomized, Double-Blind, Placebo-Controlled Study.
Center for Medicinal Cannabis Research2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2003年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in level of HIV-related neuropathic pain as recorded on a 100mm Visual Analog Scale.
研究概览
简要总结
To evaluate whether smoked marijuana reduces pain in people with HIV-related peripheral neuropathy.
详细描述
The study will include subjects with peripheral neuropathy caused either by HIV-disease or antiretroviral medication for the treatment of HIV. A neurologist will conduct a neurological and pain evaluation to determine eligibility for the study. Subjects who meet all eligibility criteria will be admitted to the General Clinical Research Center at San Francisco General Hospital for seven days. Subjects will be randomized (like a toss of a coin) to smoke marijuana or a placebo (cigarettes with no THC).
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
- Double
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
- •HIV positive.
- •Be 18 years or older.
- •Diagnosis of HIV-related painful neuropathy.
- •Stable antiretroviral therapy or no antiretroviral therapy for at least 8 weeks.
- •Prior use of marijuana, at least 6 occasions in their lifetime prior to enrollment.
排除标准
- •(Not allowed)
- •Current use of smoked tobacco products.
- •Current methadone treatment.
- •Use of smoked marijuana within 30 days of enrollment.
- •Diagnosis of diabetes mellitus.
- •Currently receiving treatment with corticosteroids.
- •Use of INH, dapsone or metronidazole within 8 weeks prior to enrollment.
- •Severe heart disease, uncontrolled high blood pressure or lung disease.
- •Women who are pregnant or breastfeeding.
结局指标
主要结局
Change in level of HIV-related neuropathic pain as recorded on a 100mm Visual Analog Scale.
次要结局
- Change in level of experimentally-induced pain.
研究者
研究点 (2)
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