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临床试验/NCT05944705
NCT05944705招募中不适用

Commercially Available Cannabis (Hemp) Products for Immune Support: A Prospective Observational Study to Evaluate Safety and Effects

Center For Interventional Pain and Spine1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
1
主要终点
Adverse Events and Serious Adverse Eventss

研究概览

简要总结

This study will be a prospective observation of the use of commercially available hemp and cannabis products marketed for immune support.

详细描述

In the era of COVID-19, there has been much speculation about the risks and benefits of cannabis use for immune support. It is well known that the endocannabinoid system plays a role in the regulation of the immune response and its role in inflammation reduction may be useful in terms of a potential adjunctive therapy for acute infection. Cannabis products vary widely in their composition and may have a varying effect based on the strain and the associated terpenes. Here, we aim to track cannabis and hemp usage during an acute infection to understand it's safety and effects in a symptomatic population.

Given the fast and widespread acceptance and use of cannabis products in the US market, commercial use has outpaced randomized controlled trials (RCTs). Thus, carefully designed observational studies are important to understand how these products are affecting consumers. Prospective observational designs allow for real-world examinations of commercialized products with similar effect sizes to RCTs. Although observational designs have some drawbacks, a review covering 1,583 meta-analyses across 228 medical conditions compared the effect sizes from RCTs with those from observational studies for the same medical conditions and found no differences between the two. (1) These data provide evidence that a carefully designed observational study can help us better understand the effects of commonly used products such as cannabis edibles. The aim of this observational study is to evaluate the safety and associated effects of commercially available cannabis products in the US in symptomatic individuals seeking them for immune support.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years of age or older
  • Able to read and write in English
  • Active participants in the Pennsylvania medical marijuana program (for cannabis product users)
  • Currently experiencing one or more of the following symptoms due to an acute illness:
  • Fever or chills
  • Muscle or body aches
  • Sore throat
  • Congestion or runny nose
  • Nausea or Vomiting
  • Agrees to consume their chosen hemp or cannabis product (for the cannabis arm) and to not use a different hemp or cannabis product through the duration of the study
  • Agrees to continue to abstain from using hemp or cannabis (for the non-cannabis/hemp using arm)
  • Must have smart phone or email and access to the internet
  • Be able to comply with study requirements including baseline, completion of electronic questionnaires, and study timeline parameters.

排除标准

  • Women who are pregnant, breastfeeding, or planning to become pregnant.
  • Known allergy to any compounds in hemp or cannabis.
  • Endorses suicidal intent
  • Immunocompromised individuals
  • Unwilling or unable to comply with study procedures
  • Terminal Illness with life expectancy less than 1 year

结局指标

主要结局

Adverse Events and Serious Adverse Eventss

时间窗: To Study Completion, approximately 30 days

Evaluate the safety of commercially available hemp and cannabis products marketed for immune support through assessment of AEs and SAEs. AEs and SAEs will also be collected for the non-user group

次要结局

  • Profile of Mood States (POMS)(30 days)
  • Quality of Life and Sleep via Patient-Reported Outcomes Measurement Information System (PROMIS-29)(30 days)
  • Time back to work/normal activities(30 days)
  • Symptom Improvement(30 days)
  • Concomitant medications and supplements(To Study Completion, approximately 30 days)

研究者

发起方
Center For Interventional Pain and Spine
申办方类型
Other
责任方
Sponsor

研究点 (1)

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