Effects of a Hemp-derived Cannabidiol and Cannabidiolic-acid Oral Extract on Resting-state Electroencephalography and Neuropathic Pain Symptoms in People With Spinal Cord Injury
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Change in neuropathic pain intensity or unpleasantness.
研究概览
简要总结
The main purposes of this study are to (1) measure the effect of CBD/CBD-A on pain symptoms, pain intensity, pain unpleasantness, and skin sensitivity to hot and cold temperatures; and (2) measure the effect of CBD on brain electrical activity with electroencephalography (EEG).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or Women;
- •18-64 years of age with an incomplete or complete acquired traumatic SCI;
- •Must have experienced neuropathic pain for a minimum of three months before entering the study (neuropathic pain will be assessed using the International SCI Pain Classification);
- •The pain intensity must be in the moderate to severe category, which will be defined as a score of at least four on an NRS (range of 0 to 10).
- •Must have previous experience with consuming cannabis and or cannabinoids.
排除标准
- •Current drug (DAST-10: >6) or alcohol abuse (AUDIT: >10);
- •Current use of cannabis plant or cannabis products (CBD or CBD+THC) or any other drugs of abuse (unless prescribed) including alcohol;
- •Presence of significant medical illness (e.g., diabetes, obesity, cardiovascular disease, hypertension, hepatitis) or other significant neurological trauma;
- •History of or current severe psychopathology (e.g., major depressive disorder, bipolar disorder, schizophrenia, post-traumatic stress disorder) judged by the investigator to put the subject at greater risk of experiencing an adverse event;
- •Adults who are unable to consent, women who are pregnant, breastfeeding, or not practicing an effective form of birth control (condoms, diaphragm, birth control pill, IUD), and prisoners;
- •Current pregnancy. Pregnancy will be evaluated using a pregnancy test during the first study visit. Female subjects of childbearing potential will be required to use two forms of effective birth control for the 3 months prior to participating in the study and continuing for 1 month after completion of the study;
- •Have a history of renal or hepatic disease: or
- •Have elevated serum creatinine above the laboratory upper limit of normal (ULN): or
- •Have elevated serum transaminases (ALT or AST) above the ULN: or
- •Have elevated total bilirubin above the ULN; or
- •Take valproate, due increased risk of liver enzyme elevation; or
- •Currently using strong CYP2C19 and CYP3A4 inducers; or
- •Have suicidal ideation (subjects should be screened for suicidal ideation); or
- •Cannot abstain from the use of alcohol during the study period, due to increased risk of sedation; or
- •Have a known or suspected hypersensitivity to cannabidiol or tetrahydrocannabinol.
- •Have a known or suspected hypersensitivity to sesame seed oil, lecithin, or bovine gelatin.
研究组 & 干预措施
CBD/CBD-A followed by placebo group
Participants in this group will receive a one time dose of CBD/CBD-A on visit 2, followed by a placebo on visit 3 after a two-week period.
干预措施: CBD/CBD-A (Drug)
CBD/CBD-A followed by placebo group
Participants in this group will receive a one time dose of CBD/CBD-A on visit 2, followed by a placebo on visit 3 after a two-week period.
干预措施: Placebo (Other)
Placebo followed by CBD/CBD-A group
Participants in this group will receive a placebo on visit 2, followed by a one time of CBD/CBD-A on visit 3 after a two-week period.
干预措施: CBD/CBD-A (Drug)
Placebo followed by CBD/CBD-A group
Participants in this group will receive a placebo on visit 2, followed by a one time of CBD/CBD-A on visit 3 after a two-week period.
干预措施: Placebo (Other)
结局指标
主要结局
Change in neuropathic pain intensity or unpleasantness.
时间窗: Baseline, approximately 3 hours post intervention, and approximately 6 hours post intervention
Assess changes in pain intensity and unpleasantness of the worst neuropathic pain using a numerical rating scale from 0-10 (0 no pain and 10 worst imaginable/unpleasant pain).
Change in brain electrocortical activity at rest.
时间窗: Baseline and 3 hours post intervention
Assess brain electrocortical activity at rest using a 64-channel Biosemi EEG system and conducting EEG power spectrum analysis
次要结局
- Change in neuropathic pain symptoms severity using the NPSI.(Baseline, approximately 3 hours post intervention, and approximately 6 hours post intervention)
- Change in sensory function using QST.(Baseline and 3 hours post intervention)
- Change in state anxiety using the STAI.(Baseline, approximately 3 hours post intervention, and approximately 6 hours post intervention)
- Subjective Drug Effects(Baseline, approximately 3 hours post intervention, and approximately 6 hours post intervention)
研究者
Eva Widerstrom-Noga
Research Professor
University of Miami