ISRCTN68314063已完成不适用
Smoked cannabis for chronic neuropathic pain: a randomised controlled trial
Montreal General Hospital (Canada)0 个研究点目标入组 32 人开始时间: 2006年6月21日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 18/01/2008:
- •1. Ambulatory, otherwise healthy, men and women with neuropathic pain of at least three months duration which is due to trauma or surgery, with clinical evidence of allodynia or hyperalgesia
- •2. Average weekly pain intensity score less than or equal to 4 on a 10 cm visual analogue scale (anchors: 0 is no pain, 10 is worst pain ever)
- •3. Stable analgesic regimen (no anticipated change in therapy over the next two months)
- •4. No cannabis use in the past month
- •5. Ability to comply with smoking procedure
- •6. 18 years and older
- •7. Ability to attend research centre twice weekly for four weeks over a two month period, and to be able to be contacted by telephone during the study period
- •8. Normal liver (aspartate aminotransferase [AST] less than 3 x normal) and renal function (serum creatinine less than 133 µmol/l)
- •9. Haematocrit greater than 35%
- •10. Negative serum beta human chorionic gonadotrophin [ßhCG] pregnancy test
- •11. Women of childbearing potential should use adequate contraception during study and for three months after study
- •12. Proficient in English or French
- •13. Willing and able to give written informed consent
- •Previous inclusion criteria:
- •1. Ambulatory, otherwise healthy, men and women with neuropathic pain of at least three months duration which is due to trauma or surgery, with clinical evidence of allodynia or hyperalgesia
- •2. Average weekly pain intensity score 5= on a 10 cm visual analogue scale (anchors: 0 is no pain, 10 is worst pain ever)
- •3. Stable analgesic regimen (no anticipated change in therapy over the next two months)
- •4. No cannabis use in the past month
- •5. Ability to comply with smoking procedure
- •6. 18 years and older
- •7. Ability to attend research centre twice weekly for four weeks over a two month period, and to be able to be contacted by telephone during the study period
- •8. Normal liver (aspartate aminotransferase [AST] <3 x normal) and renal function (serum creatinine <133 µmol/l)
- •9. Haematocrit >38%
- •10. Negative serum beta human chorionic gonadotrophin [ßhCG] pregnancy test
- •11. Women of childbearing potential should use adequate contraception during study and for three months after study
- •12. Proficient in English or French
- •13. Willing and able to give written informed consent
排除标准
- •Current exclusion criteria as of 18/01/2008:
- •1. Positive results of cannabinoid screening
- •2. Pain due to cancer or nociceptive causes (e.g. acute trauma, herpes zoster)
- •3. Unstable heart disease such as arrhythmias, cardiac failure, ischaemic heart disease, hypertension
- •4. Current substance abuse/dependence (including cannabis) as defined by the Diagnostic and Statistical Manual of mental disorders fourth edition (DSM IV) criteria
- •5. Unstable or untreated lung disease (tuberculosis [TB], asthma, carcinoma, chronic obstructive pulmonary disease [COPD])
- •6. History of uncontrolled psychotic disorder in the past year (for example, schizophrenia or bipolar disorder)
- •7. Current suicidal ideation, as assessed by clinical psychologist
- •8. Pregnancy and/or breast-feeding
- •9. Participation in other clinical trial in the 30 days prior to enrolment
- •10. Ongoing medical insurance or compensation claims (may confound subjective pain intensity ratings if pain has possible secondary gain)
- •Previous exclusion criteria:
- •1. Positive results of cannabinoid screening
- •2. Pain due to cancer or nociceptive causes (e.g. acute trauma, herpes zoster)
- •3. Cardiac arrhythmias, cardiac failure, ischaemic heart disease
- •4. Current substance abuse/dependence (including cannabis) as defined by the Diagnostic and Statistical Manual of mental disorders fourth edition (DSM IV) criteria
- •5. Pulmonary complications (tuberculosis [TB], asthma, carcinoma, chronic obstructive pulmonary disease [COPD])
- •6. History of psychotic disorder (for example, schizophrenia or bipolar disorder)
- •7. Current suicidal ideation, as assessed by clinical psychologist
- •8. Pregnancy and/or breast-feeding
- •9. Participation in other clinical trial in the 30 days prior to enrolment
- •10. Ongoing medical insurance or compensation claims (may confound subjective pain intensity ratings if pain has possible secondary gain)
研究者
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