A Novel Non-Opioid Topical Therapy for Chronic Musculoskeletal Pain
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 77
- 主要终点
- Levels of plasma cannabinoid and cannabinoid metabolites
研究概览
简要总结
Our proposal objective is to evaluate if state-regulated topical CBD-based products relieve chronic musculoskeletal pain and/or absorb into the bloodstream.
详细描述
The goal of this study is to learn more about the analgesic efficacy of state-regulated topical cannabinoid products (creams, lotions, salves, etc) and to determine if these topical products are absorbed systemically and can be detected in blood samples. Given that state-regulated dispensary products cannot be brought onto the university campus, this observational study design utilizes a Mobile Pharmacology Laboratory that will go to study participants' homes. Blood samples and other assessments will taken in the mobile lab prior to use of a topical cannabinoid product and at several time points afterwards (4 hours, 24 hours, and 2 weeks). Participants will also collect microsamples of blood using a small device at home at three time points during the first 2-72 hours after application of the product.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic peripheral joint pain
- •Desire and intent to use a topical cannabinoid product containing cannabidiol (CBD) or a combination of CBD and tetrahydrocannabinol (THC) to alleviate this pain
排除标准
- •Current or prior use of topical cannabis
- •Unwilling or unable to discontinue other (non-topical) cannabis use for four weeks prior to and during study participation through week two
- •Intent to use a THC-predominant topical product (ratio greater than 1:1 of THC to CBD)
- •Current or history of substance use disorder
- •History or diagnosis of schizophrenia, bipolar or a psychotic disorder
- •Surgery on the affected musculoskeletal location within the 3 months prior to enrollment
- •Planned surgery or procedure on the affected musculoskeletal location during participation in the study
- •Allergy or prior severe adverse reaction to cannabis (cardiovascular event, psychosis, etc)
- •Current or prior cannabis abuse/dependence
- •Cognitive disability that interferes with ability to provide consent or understand study procedures
- •History of seizure disorder
- •Pending legal action or workers compensation
- •Pregnant females or females intending to become pregnant during the study period
- •Lactating females
- •Chronic/severe medical illness (renal disease, liver disease, cancer, significant cardiovascular disease, or history of myocardial infarction)
- •Active component military
结局指标
主要结局
Levels of plasma cannabinoid and cannabinoid metabolites
时间窗: Baseline to 2 weeks
Four venous blood samples will be obtained at baseline, 4 hours, 24 hours, and 2 weeks after first use of the selected topical cannabinoid.
Change in in PROMIS Pain Interference Score from Baseline to 2 months
时间窗: Assessed at baseline, 4 hours, 24 hours, 2 weeks and 2 months
The PROMIS Pain Interference (Short Form 6a) includes 6 items that assess the self-reported consequences of pain on various aspects of life including social, cognitive, emotional, physical and recreational activities. Participants rate these consequences on a Likert Scale that ranges from 1 (Not at all) to 5 (Very much). The scores are then converted to T-scores, with higher values indicating greater pain interference.
次要结局
- Reported drug effects(Baseline, 4 hours, 24 hours, 2 weeks, 2 months)
- Change in in PROMIS Pain Intensity Score from Baseline to 2 months(Assessed at baseline, 4 hours, 24 hours, 2 weeks and 2 months)
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Profile from Baseline to 2 months(Assessed at baseline, 4 hours, 24 hours, 2 weeks and 2 months)
- Change in Patients' Global Impression of Change (PGIC) from Baseline to 2 Months(Assessed at baseline, 4 hours, 24 hours, 2 weeks and 2 months)
- Opioid and non-opioid pain medications use(Daily through 2 weeks)
- Change in NIH Toolbox® List Sorting Working Memory Test from Baseline to 2 Weeks(Assessed at baseline, 4 hours, 24 hours, 2 weeks)
- Change in NIH Toolbox® Oral Symbol Digit Test from Baseline to 2 Weeks(Assessed at baseline, 4 hours, 24 hours, 2 weeks)
- Change in Fine Motor Function from Baseline to 2 Weeks(Assessed at baseline, 4 hours, 24 hours, 2 weeks)
- Change in Gross Motor Function from Baseline to 2 Weeks(Assessed at baseline, 4 hours, 24 hours, 2 weeks)
- Change Patient Specific Functional Scale from Baseline to 2 Months(Assessed at baseline, 4 hours, 24 hours, 2 weeks and 2 months)
- Change in NIH Toolbox® Picture Vocabulary Test from Baseline to 2 Weeks(Assessed at baseline, 4 hours, 24 hours, 2 weeks)
- Abuse liability(Assessed at baseline, 4 hours, 24 hours, 2 weeks and 2 months)
- Participant Treatment Expectations and Impressions(Assessed at baseline, 4 hours, 24 hours, 2 weeks and 2 months)
- Participant Perceived Efficacy(Assessed at baseline, 4 hours, 24 hours, 2 weeks and 2 months)
- Participant Preference vs Other Analgesics(Assessed at baseline, 4 hours, 24 hours, 2 weeks and 2 months)
- Participant Reported Adverse Effects(Assessed at baseline, 4 hours, 24 hours, 2 weeks and 2 months)
- Change in NIH Toolbox® Flanker Inhibitory Control and Attention Test from Baseline to 2 Weeks(Assessed at baseline, 4 hours, 24 hours, 2 weeks)
- Change in NIH Toolbox® Pattern Comparison Processing Speed Test from Baseline to 2 Weeks(Assessed at baseline, 4 hours, 24 hours, 2 weeks)
- Half life analysis of cannabinoid and cannabinoid metabolites(baseline through 2 weeks)
- Clearance analysis of cannabinoid and cannabinoid metabolites(baseline through 2 weeks)
- Volume of distribution analysis of cannabinoid and cannabinoid metabolites(baseline through 2 weeks)