Observing the effects of cannabis products on immune support

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

This study is looking at how using hemp and cannabis products for immune support affects people with infections like the flu and COVID-19.

Quick facts

• Study type: Observational
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Center For Interventional Pain and Spine (other)
• Locations: 1 site (Bryn Mawr, Pennsylvania)
• Trial ID: NCT05944705 on ClinicalTrials.gov

What this trial studies

This observational study aims to track the use of commercially available hemp and cannabis products marketed for immune support among individuals experiencing acute infections like influenza and COVID-19. Participants will be monitored for their consumption of these products and the associated effects on their symptoms. The study seeks to understand the safety and efficacy of cannabis in real-world settings, particularly given the rapid acceptance of these products in the market. By utilizing a prospective observational design, the research aims to provide insights comparable to randomized controlled trials, despite the inherent limitations of observational studies.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who are active participants in the Pennsylvania medical marijuana program and currently experiencing symptoms of an acute illness.

Not a fit: Patients who are pregnant, breastfeeding, or planning to become pregnant will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the safety and efficacy of cannabis products for immune support during acute infections.

How similar studies have performed: While observational studies on cannabis use are becoming more common, this specific approach to studying commercially available products for immune support is relatively novel.

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

Where this trial is running

Bryn Mawr, Pennsylvania

• Center for Interventional Pain and Spine — Bryn Mawr, Pennsylvania, United States (RECRUITING)

Study contacts

• Principal investigator: Philip Kim, MD — Center For Interventional Pain and Spine
• Study coordinator: Ashley M Scherer, MS

Conditions: Influenza, COVID-19, Common Cold