The Impact of Medical Cannabis on Pain and Inflammation in People Living With HIV
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Change in Pain Severity Score
研究概览
简要总结
This study will examine how medical cannabis use affects neuropathic pain, inflammation and adverse events in people living with HIV (PLWH) with neuropathic pain. The investigators will observe how varying ratios of tetrahydrocannabinol (THC) and cannabidiol (CBD) in medical cannabis impact neuropathic pain, inflammation and adverse events.
详细描述
This study will examine how medical cannabis use affects neuropathic pain in PLWH with neuropathic pain. The investigators will enroll adults with HIV who have a) neuropathic pain, b) are actively certified for medical cannabis, and c) intend to have soft gel capsule products dispensed at Vireo (medical cannabis dispensary). The investigators will observe how pain and inflammation change in participants after they are randomized to receive high THC:low CBD product, an equal THC:CBD product, a low THC:high CBD product, or placebo by our collaborator in a separate study. Over 14 weeks, data sources will include questionnaires, blood samples, urine samples; medical, pharmacy, and Prescription Monitoring Program (PMP) records. The primary independent variable will be type of medical cannabis product dispensed at dispensary, and the primary outcome will be self-reported pain.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>=18 years old
- •Diagnosis of HIV
- •Fluency in English
- •Active certification for medical cannabis
- •ICD-10 diagnosis code for neuropathic pain, OR Neuropathic pain in problem list of electronic medical record, OR Neuropathic pain per medical cannabis certification form, OR Neuropathic Pain Questionnaire-Short Form>0
排除标准
- •Inability to provide informed consent
- •Inability to complete 14 weeks of study visits
- •Medical cannabis use within 14 days of enrollment, and no medical cannabis dispensed within 30 days of enrollment
- •Unique pain symptoms (e.g., multiple sclerosis, rheumatoid arthritis)
- •Terminal illness
- •Current or prior psychotic disorder
- •Unregulated cannabis use in the past 14 days; opioid or cocaine use in the past 30 days
- •Dispensed opioids within 30 days
- •Non-steroidal anti-inflammatory use within 7 days prior to enrollment
- •Steroid use within the past 14 days with duration of therapy >=21 days
- •COVID vaccination or booster within 14 days of screening
- •Active or acute cardiac disease based on clinician chart review.
研究组 & 干预措施
Coupon for a Discounted Placebo Product
We will observe participants who were previously randomized to a coupon for discounted placebo soft-gel capsules by our collaborators, Vireo.
干预措施: Receipt of Coupon for Placebo Soft-Gel Capsule (Other)
Coupon for a Discounted High THC Product
We will observe participants who were previously randomized to a coupon for discounted 4.29 mg THC/0.72 mg CBD soft-gel capsules by our collaborators, Vireo.
干预措施: Receipt of Coupon for High THC Soft-Gel Capsule (Other)
Coupon for a Discounted Equal THC and CBD Product
We will observe participants who were previously randomized to a coupon for discounted 2.5 mg THC/2.5 mg CBD soft-gel capsules by our collaborators, Vireo.
干预措施: Receipt of Coupon for Equal THC and CBD Soft-Gel Capsule (Other)
Coupon for a Discounted High CBD Product
We will observe participants who were previously randomized to a coupon for discounted 0.25 mg THC/4.75 mg CBD soft-gel capsules by our collaborators, Vireo.
干预措施: Receipt of Coupon for High CBD Soft-Gel Capsule (Other)
结局指标
主要结局
Change in Pain Severity Score
时间窗: At weekly intervals from Baseline to 14 weeks
Change in self-reported Pain Severity was measured at weekly intervals from baseline through 14 weeks using the Brief Pain Inventory (BPI) pain severity subscale. The BPI Pain Severity subscale uses a 0-10 numerical rating scale where 0 = "No pain at all" and 10 = "Pain as bad as you can imagine; completely interferes" such that higher scores were associated with increased Pain Severity. Participants were asked to assign a score to their pain, on average, over the prior week. Scores were summarized by study arm. For purposes of this study change in Pain Severity scores from baseline to 14 weeks following intervention were summarized and reported with positive values being indicative of increased pain severity compared to baseline and negative values being indicative of decreased pain severity compared to baseline.
次要结局
- Change in Circulating Levels of Anti-inflammatory Cytokines - Interleukin-10 (IL-10)(From Baseline to 14 weeks)
- Change in Circulating Levels of Anti-inflammatory Cytokines - Interleukin-4 (IL-4)(From Baseline to 14 weeks)
- Change in Circulating Levels of Pro-inflammatory Cytokines - Tumor Necrosis Factor Alpha (TNFa)(From Baseline to 14 weeks)
- Change in Circulating Levels of Pro-inflammatory Cytokines - Interleukin-6 (IL-6)(From Baseline to 14 weeks)
- Change in Antiretroviral Medication Adherence Score(From Baseline to 14 weeks)
- Change in HIV Viral Load Suppression(From Baseline to 14 weeks)
- Change in Depression Score(From Baseline to 14 weeks)
- Change in Anxiety Score(From Baseline to 14 weeks)