An Observational Study of the Effects of Edible Cannabis and Its Constituent Cannabinoids on Pain, Inflammation, and Cognition
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 268
- 试验地点
- 1
- 主要终点
- Pain Interference: Roland Morris Disability Questionnaire (RMDQ)
研究概览
简要总结
This study tests the effects of cannabinoid levels in blood on pain relief, inflammation, and cognitive dysfunction in chronic pain patients who choose to use edible cannabis. Over a two-week period, participants use an edible product of their choice. Blood levels of 9-delta-tetrahydrocannabinol (THC) and cannabidiol (CBD) will be measured before, during, and after the two-week exposure period to determine whether there are associations with pain, inflammation, sleep, physical activity, anxiety/depression, and cognitive dysfunction. After the two-week self-administration period, participants will be followed for six months to collect self-report data on cannabis use, pain levels, sleep quality, and mental health symptoms.
详细描述
The National Center for Health Statistics reports that approximately 76 million Americans suffer from chronic pain, affecting the lives of more Americans than cancer, diabetes, and heart disease combined. Perhaps because of its ubiquity and the challenge to its treatment, relief from chronic pain is by far the most commonly cited condition by patients for use of marijuana, with 87%-94% of medical marijuana users reporting using for relief of a pain condition.
Although the mechanisms are still unclear, marijuana and its constituent cannabinoids, including 9-delta-tetrahydrocannabinol (THC), are thought to be involved in reducing pain and associated inflammation. However, THC is also associated with harm in the form of cognitive dysfunction. Synergistic interactions of multiple cannabinoids are believed to produce different effects on both pain relief and cognitive function as compared to THC alone. For example, cannabidiol (CBD) is another primary cannabinoid that may work synergistically with THC in a multi-target analgesic approach.
This study examines the effects of cannabinoids in edible form on pain relief, inflammation, and cognitive dysfunction in chronic pain patients who choose to use marijuana in the context of a short-term (2 weeks), patient-oriented, observational design and a mobile pharmacology and phlebotomy lab.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Intent to initiate use of marijuana to treat chronic pain
- •At least one episode of lifetime marijuana use, but infrequent marijuana use for prior six months
- •Self-reported non-specific chronic low back pain for at least three months
- •Health eligibility approved by study physician
- •At least mild to moderate pain intensity OR pain interferes with important life functions
排除标准
- •Other drug use (cocaine, methamphetamine, etc.) in the past 3 days and/or actively seeking or in treatment for any substance use disorder
- •Use of marijuana to treat pain at any time in lives
- •Current use of psychotropic medications (other than SSRIs and ADHD meds), or use of antivirals, steroids, or regular use of maximal doses of NSAIDS
- •A daily tobacco user
- •Are currently pregnant or trying to become pregnant
- •Acute illness (other than chronic pain) or any immune-related disease (e.g., HIV)
结局指标
主要结局
Pain Interference: Roland Morris Disability Questionnaire (RMDQ)
时间窗: Change over two time points over 2 weeks: Baseline (before 2 weeks of edible use), Pre-Administration (after 2 weeks of use and before acute administration) using the total RMDQ score (0-24).
The Roland Morris Disability Questionnaire assesses self-rated physical disability caused by low back pain. Scores range from 0 to 24, with higher scores indicating more pain interference.
Inflammation: Circulating Levels of Cytokines
时间窗: Change over two time points over 2 weeks: Baseline (before 2 weeks of edible use) and Pre-Administration (after 2 weeks of use and before acute administration).
Tests levels of recent inflammation (panel of inflammatory markers) before and after cannabis use. Higher numbers indicate higher levels of circulating pro-inflammatory cytokines. Results are in pg/mL and are separated by the three cytokines: IL-1b, IL-6, and IL-10.
Flanker Inhibitory Control Attention Task (FICA) & International Shopping List Task (ISLT)
时间窗: Change over two time points over 2 weeks: Baseline (before 2 weeks of edible use), Pre-Administration (after 2 weeks of use and before acute administration).
Co-outcomes testing cognitive impairment in the domains of immediate and delayed recall (ISLT) and attention and inhibitory control (FICA). Cognitive outcomes are measured in standard scores (e.g. Range of \>70 to \>140 (Mean of 100 and SD of 15) with higher scores indicating better performance) and can be averaged to reflect a Standard score of overall cognitive function.
Functional Assessment of Cancer Therapy Cognitive Scale (FACT-Cog)
时间窗: Change over two time points over 2 weeks: Baseline (before 2 weeks of edible use), Pre-Administration (after 2 weeks of use and before acute administration).
Subjective report of cognitive function using the Perceived Cognitive Impairments subscale of the Functional Assessment of Cancer Therapy Cognitive Scale (FACT-Cog). Possible scores range from 0-80 where higher scores are associated with higher levels of perceived impairment.
次要结局
- Pain Intensity: Current Pain Using NIH Pain Intensity Scale.(Change over 2 weeks)
- Health & Wellbeing(Change over 2 weeks)
- Pittsburgh Sleep Quality Assessment (PSQI)(Change over 4 weeks)
- Motor Function(Change over 2 weeks)
- Depression and Stress(Change over 2 weeks)
- Acute Cognitive Impairment: Flanker Inhibitory Control Attention Task (FICA) and International Shopping List Task (ISLT).(2 Weeks)
- Patient Global Impression of Change: Global Impression of Change Scale (PGIC).(Change over 2 week primary exposure period.)
研究者
L. Cinnamon Bidwell
Assistant Research Professor
University of Colorado, Boulder