Pain Research: Innovative Strategies With Marijuana
关键词
抽象
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.
日期
| 最后验证: | 02/29/2020 |
| 首次提交: | 04/16/2018 |
| 提交的预估入学人数: | 05/08/2018 |
| 首次发布: | 05/10/2018 |
| 上次提交的更新: | 03/22/2020 |
| 最近更新发布: | 03/23/2020 |
| 实际学习开始日期: | 05/31/2018 |
| 预计主要完成日期: | 10/30/2021 |
| 预计完成日期: | 03/30/2022 |
状况或疾病
干预/治疗
Drug: Cannabis Edible
相
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 |
| 取样方式 | Non-Probability Sample |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - 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 Exclusion Criteria: - 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) |
结果
主要结果指标
1. Pain Interference: Roland Morris Disability Questionnaire (RMDQ) [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).]
2. Inflammation: Circulating Levels of Cytokines [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).]
3. Flanker Inhibitory Control Attention task (FICA) & International Shopping List Task (ISLT) [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).]
4. Functional Assessment of Cancer Therapy Cognitive Scale (FACT-Cog) [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).]
次要成果指标
1. Pain Intensity: Current, Average and Worst pain using NIH Pain intensity scale. [Change over four time points over 2 weeks: Baseline (before start of edible use), Pre-Administration (after 2 weeks of edible use and post-acute administration), and Post-Administration (1 and 2 hours post-use. acute measure of edible cannabis effects).]
2. Health & Wellbeing [Change over four time points over 2 weeks: Baseline (before start of edible use), Pre-Administration (after 2 weeks of edible use and post-acute administration), and Post-Administration (1 and 2 hours post-use. acute measure of edible cannabis effects).]
3. Pittsburgh Sleep Quality Assessment (PSQI) [Change over four time points over 2 weeks: Baseline (before start of edible use), Pre-Administration (after 2 weeks of edible use and post-acute administration), and Post-Administration (1 and 2 hours post-use. acute measure of edible cannabis effects).]
4. Motor function [Change over four time points over 2 weeks: Baseline (before start of edible use), Pre-Administration (after 2 weeks of edible use and post-acute administration), and Post-Administration (1 and 2 hours post-use. acute measure of edible cannabis effects).]
5. Depression and Mood [Change over four time points over 2 weeks: Baseline (before start of edible use), Pre-Administration (after 2 weeks of edible use and post-acute administration), and Post-Administration (1 and 2 hours post-use. acute measure of edible cannabis effects).]
6. Acute Cognitive impairment: Flanker Inhibitory Control Attention task (FICA) and International Shopping List Task (ISLT). [Acute changes in three time points over 2 hours: Pre-Administration (after 2 weeks of use, before acute administration), Post-Administration 1-hr & 2-hr (after 2 weeks of use, 1 and 2 hours after acute administration).]
7. Inflammation: Circulating Levels of Cytokines [Acute changes in three time points over 2 hours: Pre-Administration (after 2 weeks of use, before acute administration), Post-Administration 1-hr & 2-hr (after 2 weeks of use, 1 and 2 hours after acute administration).]
8. Patient Global Impression of Change: Global Impression of Change Scale (PGIC). [Change over six month study, including after 2 week primary exposure period.]
其他成果措施
1. Exploratory: Daily Follow-up Messages [2 weeks (daily)]
2. Exploratory: Monthly Follow-up Surveys [6 months (monthly)]
3. Objective physical activity/exercise [2 weeks]
4. Physical activity/exercise [2 weeks]
