Commercially Available Cannabis Products for Immune Support

Center For Interventional Pain and Spine

Status: Enrolling

Conditions: COVID-19; Influenza; Common Cold

Treatments: Dietary Supplement: Immune Support Supplement

Study type: Observational

Funder types: Other

Identifiers

NCT05944705

CannabisforImmuneSupport

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

200 participants in 2 patient groups

Symptomatic individuals using hemp or cannabis products for immune support

Description:

Individuals with symptomatic illness that utilize a proprietary hemp or cannabis product to aid in their recovery

Treatment:

Dietary Supplement: Immune Support Supplement

Symptomatic individuals not currently using hemp or cannabis products for immune support

Description:

Individuals without symptomatic illness that do not utilize the proprietary hemp or cannabis product to aid in their recovery