Clinical trial NCT05944705: Commercially Available Cannabis Products for Immune Support
Official title: Commercially Available Cannabis (Hemp) Products for Immune Support: A Prospective Observational Study to Evaluate Safety and Effects
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Influenza
COVID-19
Common Cold
Lead sponsor: Center For Interventional Pain and Spine
Sponsor class: OTHER
Collaborators: name: Agronomed LLC
First posted: 2023-07-13
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals who are suffering an acute illness

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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. 18 years of age or older
2. Able to read and write in English
3. Active participants in the Pennsylvania medical marijuana program (for cannabis product users)
4. Currently experiencing one or more of the following symptoms due to an acute illness:

   1. Fever or chills
   2. Cough
   3. Fatigue
   4. Muscle or body aches
   5. Headache
   6. Sore throat
   7. Congestion or runny nose
   8. Nausea or Vomiting
   9. Diarrhea
5. 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
6. Agrees to continue to abstain from using hemp or cannabis (for the non-cannabis/hemp using arm)
7. Must have smart phone or email and access to the internet
8. Be able to comply with study requirements including baseline, completion of electronic questionnaires, and study timeline parameters.

Exclusion Criteria:

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

Primary outcomes:
measure: Adverse Events and Serious Adverse Eventss
timeFrame: To Study Completion, approximately 30 days
Secondary outcomes:
measure: Symptom Improvement
timeFrame: 3 days
measure: Symptom Improvement
timeFrame: 5 days
measure: Symptom Improvement
timeFrame: 10 days
measure: Symptom Improvement
timeFrame: 15 days
measure: Symptom Improvement
timeFrame: 30 days
measure: Profile of Mood States (POMS)
timeFrame: 3 days
measure: Profile of Mood States (POMS)
timeFrame: 5 days
measure: Profile of Mood States (POMS)
timeFrame: 10 days
measure: Profile of Mood States (POMS)
timeFrame: 15 days
measure: Profile of Mood States (POMS)
timeFrame: 30 days
measure: Quality of Life and Sleep via Patient-Reported Outcomes Measurement Information System (PROMIS-29)
timeFrame: 3 days
measure: Quality of Life and Sleep via Patient-Reported Outcomes Measurement Information System (PROMIS-29)
timeFrame: 5 days
measure: Quality of Life and Sleep via Patient-Reported Outcomes Measurement Information System (PROMIS-29)
timeFrame: 10 days
measure: Quality of Life and Sleep via Patient-Reported Outcomes Measurement Information System (PROMIS-29)
timeFrame: 15 days
measure: Quality of Life and Sleep via Patient-Reported Outcomes Measurement Information System (PROMIS-29)
timeFrame: 30 days
measure: Time back to work/normal activities
timeFrame: 3 days
measure: Time back to work/normal activities
timeFrame: 5 days
measure: Time back to work/normal activities
timeFrame: 10 days
measure: Time back to work/normal activities
timeFrame: 15 days
measure: Time back to work/normal activities
timeFrame: 30 days
measure: Concomitant medications and supplements
timeFrame: To Study Completion, approximately 30 days
Other outcomes:
Locations:
city: Bryn Mawr
country: United States
facility: Center for Interventional Pain and Spine
state: Pennsylvania
Study officials:
affiliation: Center For Interventional Pain and Spine
name: Philip Kim, MD
role: PRINCIPAL_INVESTIGATOR
References: