The Effect of Vaporized Cannabis on Neuropathic Pain in Spinal Cord Injury
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Number of Participants Achieving a Reduction in Pain Intensity of 30% or More
研究概览
简要总结
This study will demonstrate that vaporized marijuana results in antinociception when compared to placebo in subjects with spinal cord injury. To further evaluate potential benefits and side effects, the effect of different strengths of cannabis on mood, cognition, and psychomotor performance will also be measured.
详细描述
This study will demonstrate that vaporized cannabis can produce antinociceptive effects compared to placebo in human subjects with spinal cord injury (SCI). A within-subject crossover study of the effects of cannabis versus placebo on spontaneous and evoked pain will be performed. A synopsis of antinociception with mood, cognitive impairment, psychomotor performance, and side effects will be obtained to help evaluate the utility of vaporized marijuana in SCI neuropathic pain.
This study will compare the analgesic and side effect profile of low (3.5%) to high dose (7.0%) delta 9-tetrahydrocannabinol in subjects with spinal cord injury pain. It is hypothesized that a low dose will produce a lesser degree of neuropsychological impairment while maintaining a similar degree of pain relief to the higher dose. The use of two different strengths will help determine tolerable dosing for the treatment of SCI neuropathic pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than 18 and less than 70
- •Pain intensity ≥ 4/10
- •Neuropathic pain defined as chronic pain in an area of sensory abnormality corresponding to the spinal cord or nerve root lesion, and the pain should have no primary relation to movement, inflammation or other local tissue damage
- •Leeds Assessment of Neuropathic Symptoms and Signs score greater than or equal to 12
- •Spinal cord injury of 3 or more months duration (to avoid spontaneous recovery obfuscating generalizability)
排除标准
- •Known concomitant cerebral damage/cognitive impairment (TBI, Alzheimer's Disease Vascular dementia, Parkinson's disease, dementia with Lewy Bodies and Front temporal dementia
- •Clinically significant or unstable medical condition (i.e., cardiac, respiratory, hepatic or renal disease) that, in the opinion of the investigator, would compromise participation in the study
- •Neurologic disorders unrelated to spinal cord injury that may confound the assessment of the central neuropathic pain due to spinal cord injury (hereditary neuropathies; diabetic peripheral neuropathy; traumatic neuropathy; and immune-mediated neuropathies)
- •Active substance abuse within past year using "The Substance Abuse Module of Diagnostic Interview Schedule for DSM-IV
- •Pregnancy as ascertained by a self-report and a mandatory commercial pregnancy test
- •Currently on probation or parole.
- •Hx of Schizophrenia, Bipolar Depression with Mania, current suicidal ideation or past history of suicide attempt
- •Severe depression (Patient Health Questionnaire-9 ≥ 15)
- •Current suicidal ideation
研究组 & 干预措施
Vaporization of Cannabis 6.7% THC
Inhaling of standardized measured puffs of Vaporized High Dose 6.7% THC. Monitored for 8 hours measuring psychoactive and analgesic effects.
干预措施: Vaporization of Cannabis (Drug)
Vaporization of Cannabis 2.9% THC
Inhaling standardized measured puffs of Vaporized Low Dose 2.9% THC. Monitored for 8 hours measuring psychoactive and analgesic effects.
干预措施: Vaporization of Cannabis (Drug)
Vaporization of Cannabis Placebo THC
Inhaling standardized measured puffs of Placebo THC. Monitored for 8 hours measuring psychoactive and analgesic effects.
干预措施: Vaporization of Cannabis (Drug)
结局指标
主要结局
Number of Participants Achieving a Reduction in Pain Intensity of 30% or More
时间窗: hourly pain assessments for 8 hours
Number of participants achieving a reduction of pain intensity of 30% or more, a level believed to be clinically important, was estimated for each treatment dose.
次要结局
未报告次要终点
研究者
Barth Wilsey
Research Professor
University of California, Davis