Investigation of Cannabis for Pain and Inflammation in Lung Cancer
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Change in pain ratings using The McGill Pain Questionnaire
研究概览
简要总结
Radiation therapy to the chest is used in late stage lung cancer, and it often leads to inflammation of the esophagus. The inflammation is expected to occur in about 75% of patient, and usually begin within a week of starting radiation therapy. The esophagitis causes pain and difficulty eating. It can also result in stopping or delaying treatment.Radiation therapy to the chest is used in late stage lung cancer, and it often leads to inflammation of the esophagus. The inflammation is expected to occur in about 75% of patient, and usually begin within a week of starting radiation therapy. The esophagitis causes pain and difficulty eating. The endocannabinoid system is prominent in the gastrointestinal system, and cannabis has been shown to greatly inhibit inflammation. The compound (-)-trans-Δ9-tetrahydrocannabinol (Δ-9-THC) has effects that reduce inflammation and pain. Cannabidiol is a component of cannabis that does not produce subjective or intoxicating effects, but also has prominent anti-inflammatory properties.
The goal of this study is to perform a double-blind, placebo-controlled study to investigate the efficacy of cannabis, compared to placebo, in participants undergoing RT (Radiation Therapy) for lung cancer. Cannabis that has a high concentration of cannabidiol will be used , which is a cannabinoid that does not change perception or produce intoxication, and low in Δ-9-THC. In this way, the hope is to maximize the benefit of cannabis, while lowering the possible side effects of cannabis in medically ill participants.
详细描述
Study Outline
Patients will be referred to the study from their physician, who will have the patients medically cleared for participation.
The patients will then undergo additional screening for the study. A study physician will review all study procedures with potential participants, including the potential side effects. Patients will be shown the facilities and informed of being monitored at all times.
Patients will be randomized using a randomization and assigned to one of two groups: cannabis (15.76% CBD; 3.11% Δ-9 -THC) vs "placebo" cannabis (0.0% CBD/ 0.01% Δ-9-THC).
Participants will visit the Marijuana Research Laboratory, 3-5 days a week over 6 weeks to be administered 1-2 cannabis cigarettes over the course of a 2-3 hour session. Two cannabis conditions will be tested: Placebo (0.01% THC; 0.00% CBD) and CBD:THC (15.76% CBD; 3.11% THC) provided by the National Institute on Drug Abuse.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Lung Cancer receiving RT.
- •Able to give informed consent, and comply with study procedures.
- •History of previous experience with smoking or marijuana. On PFTs (Pulmonary Function Tests), participants must have an FEV1 (Forced Expiratory Volume in 1 second) of ≥ 1.2 liters/second or ≥ 50% predicted using the CDC reference value calculator.
排除标准
- •Meet DSM-V criteria for current major psychiatric illness, such as bipolar disorder, major depression, active suicidal intent, or psychosis, that could be exacerbated by the administration of cannabis.
- •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.
- •Women who are not practicing an effective form of birth control (condoms, diaphragm, birth control pill, IUD) or currently pregnant
- •Current (weekly) use of cannabis.
- •Participants on supplemental oxygen
- •Participants with a history of substance use disorder other than nicotine, such as opiate disorder
研究组 & 干预措施
Smoked Cannabis High CBD/low THC
Participants will visit the research laboratory 3-5 days a week over 6 weeks to be administered 1-2 Cannabis cigarettes (15.76% CBD; 3.11% -9-THC) over the course of 2-3 hours.
干预措施: Smoked Cannabis High CBD/low THC (Drug)
Smoked Placebo Cannabis Low CBD/low THC
Participants will visit the research laboratory 3-5 days a week over 6 weeks to be administered 1-2 Cannabis cigarettes Cannabis (0.0% CBD/ 0.01% -9-THC) over the course of 2-3 hours.
干预措施: Smoked Placebo Cannabis Low CBD/low THC (Drug)
结局指标
主要结局
Change in pain ratings using The McGill Pain Questionnaire
时间窗: 6 weeks
Participants will be asked to rate their pain over the 6 weeks of receiving active cannabis vs placebo.
changes in physical and emotional well being using RAND 36 item medical outcomes survey
时间窗: 6 weeks
Change in sickness-related impairment using the Sickness Impact Profile Questionnaire
时间窗: 6 weeks
Participants will be asked to rate physical symptoms for the 6 weeks of the study.
Changes in symptoms of pain using 9 item Brief Pain Inventory
时间窗: 6 weeks
Change in symptoms of pain, mood and appetite using the System (ESAS) Questionnaire
时间窗: 6 weeks
Changes in quality of life using the Multidimensional Index of Life Quality (MILQ) Questionnaire
时间窗: 6 weeks
changes in symptoms of pain, tiredness and well-being using the Edmonton Symptom
时间窗: 6 weeks
次要结局
- Assessment of subjective effects using VAS(6 weeks)
- change in eating measured using food diary(weekly for 6 weeks)
- Change in mood Hamilton Anxiety Rating Scale(6 weeks)
- Change in physiological state using the Mental Health Inventory-5 (MHI-5) Questionnaire(6 weeks)
- Change in mood using the Hamilton Depression Rating Scale(6 weeks)
- Change in mood using the Montgomery-Asberg Depression Rating Scale(6 weeks)
- Change in mood and quality of life using the Columbia Suicide Severity Rating Scale(6 weeks)
- change in cognitive status using the Short Portable Mental Status Questionnaire (SPMSQ)(6 weeks)
- Change in symptom prevalence using the Memorial Symptom Assessment Scale (MSAS)(6 weeks)
- Change in opioid use using the Opioid use Questionnaire(Daily for 6 weeks)
研究者
Diana Martinez
Associate Professor of Psychiatry at CUMC
New York State Psychiatric Institute