Investigation of Cannabis for Chronic Pain and Palliative Care
关键词
抽象
描述
The goal of this study is to perform a double-blind, placebo-controlled study to investigate the efficacy of cannabis, compared to placebo, in medically ill participants seeking relief symptoms such as pain, nausea, and vomiting. Participants who meet criteria for severe conditions will be referred from their clinicians . Cannabis that has a high concentration of cannabidiol, which is a cannabinoid that does not change perception or produce intoxication, and low in Δ-9-THC will be used. In this way, the hope is to maximize the benefit of cannabis, while lowering the possible side effects of cannabis in medically ill participants.
The overall goal of this study is to compare active high cannabidiol (CBD)/ low (−)-trans-Δ9- tetrahydrocannabinol (THC) cannabis vs placebo cannabis in patients with serious medical disorders. Participants will be referred from clinicians and will come to the laboratory daily (3-5 times weekly) for cannabis (15.76% CBD; 3.11% Δ-9-THC) vs placebo (0.0% CBD/ 0.01% Δ-9-THC). The cannabis will be vaporized or smoked as a cannabis cigarette. The participants can choose which option they prefer. The cross-over design will be used where participants receive 2 weeks of active cannabis vs two weeks of placebo in counterbalanced order, with participants blinded to the condition. The outcome measures primarily include measures of pain, with secondary measures of mood, nausea/appetite, quality of life, and the both the potentially positive and negative subjective effects of cannabis (e.g., high, mellow, anxious, paranoid).
日期
| 最后验证: | 01/31/2019 |
| 首次提交: | 02/10/2016 |
| 提交的预估入学人数: | 02/15/2016 |
| 首次发布: | 02/16/2016 |
| 上次提交的更新: | 02/25/2019 |
| 最近更新发布: | 02/27/2019 |
| 实际学习开始日期: | 11/30/2050 |
| 预计主要完成日期: | 11/30/2050 |
| 预计完成日期: | 11/30/2050 |
状况或疾病
干预/治疗
Drug: Smoked Cannabis High CBD/low THC
Drug: Smoked Placebo Cannabis Low CBD/low THC
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Active Comparator: Smoked Cannabis High CBD/low THC Participants will visit the Marijuana Research Laboratory 3-5 weekdays per week for 4 weeks to be administered 1-2 Smoked Cannabis High CBD/low THC cigarettes (15.76% CBD; 3.11% THC) over the course of a 2-3 hour session. | Drug: Smoked Cannabis High CBD/low THC Participants will visit the Marijuana Research Laboratory 3-5 weekdays per week for 4 weeks to be administered 1-2 cannabis cigarettes (15.76% CBD; 3.11% THC) over the course of a 2-3 hour session. |
| Placebo Comparator: Smoked Placebo Cannabis Low CBD/low THC Participants will visit the Marijuana Research Laboratory 3-5 weekdays per week for 4 weeks to be administered 1-2 cannabis cigarettes (0.01% THC; 0.00% CBD) over the course of a 2-3 hour session. | Drug: Smoked Placebo Cannabis Low CBD/low THC Participants will visit the Marijuana Research Laboratory 3-5 weekdays per week for 4 weeks to be administered 1-2 cannabis cigarettes (0.01% THC; 0.00% CBD) over the course of a 2-3 hour session. |
资格标准
| 有资格学习的年龄 | 21 Years 至 21 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: 1. One of the medical diagnoses (cancer, amyotrophic lateral sclerosis, Parkinson's disease, spinal cord injury, neuropathy, and phantom limb pain, thalamic pain, pain related to injury of nerve plexus/plexi, and neuropathic facial pain), with reports of pain (at least 3 on item 3 on the 9 item Brief Pain Inventory)that remains despite their current medical treatment. 2. Age 21-60 3. Able to give informed consent, and comply with study procedures 4. Experience inhaling substances. Exclusion Criteria: 1. Meet DSM-V criteria for current major psychiatric illness, such as bipolar disorder, major depression, active suicidality, or psychosis, that could be exacerbated by the administration of cannabis 2. Meet criteria for major neurological disorder, such as mild cognitive impairment or neurodegenerative disorders (such as movement disorders, dementia), that could be exacerbated by the administration of cannabis. 3. Women who are not practicing an effective form of birth control (condoms, diaphragm, birth control pill, IUD) or currently pregnant 4. Current (weekly) use of cannabis 5. Participants on supplemental oxygen 6. Participants with a substance use disorder involving marijuana or opioids. |
结果
主要结果指标
1. Change in pain ratings using the McGill Pain Questionnaire [4 weeks]
2. Change in sickness-related impairment using the Sickness Impact Profile [4 weeks]
3. changes in physical and emotional well being using the RAND-36 item medical outcomes survey, a health-related quality of life survey instrument [4 weeks]
4. Changes in symptoms of pain using the 9 item Brief Pain Inventory [4 weeks]
次要成果指标
1. Change in cognitive status using the Short Portable Mental Status Questionnaire (SPMSQ) [4 weeks]
2. Change in symptom prevalence, characteristics and degree of stress using the Memorial Symptom Assessment Scale (MSAS) [4 weeks]
3. Change in the psychological state and psychological well being using the Mental Health Inventory-5 (MHI-5) [4 weeks]
4. Changes in quality of life using the Multidimensional Index of Life Quality (MILQ) Questionnaire [4 weeks]
5. Changes in quality of life using the McGill Quality of Life Questionnaire [4 weeks]
6. Change in symptoms of pain, mood and appetite using the Edmonton Symptom Assessment System (ESAS) [4 weeks]
7. Memorial Symptom Assessment Scale (MSAS) [4 weeks]
8. Change in mood using the Hamilton Depression Rating Scale [4 weeks]
9. Change in mood Hamilton Anxiety Rating Scale [4 weeks]
10. Change in mood using the Montgomery-Asberg Depression Rating Scale [4 weeks]
11. Change in mood and quality of life using the Columbia Suicide Severity Rating Scale [4 weeks]
