Commercially Available Cannabis Products for Immune Support

NCT ID: NCT05944705

Last Updated: 2024-02-29

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2024-12-01

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.

Conditions

Influenza; COVID-19; Common Cold

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Symptomatic individuals using hemp or cannabis products for immune support

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

Immune Support Supplement

Intervention Type: DIETARY_SUPPLEMENT

Cannabinoid and co-active emulsion

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

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

No interventions assigned to this group

Interventions

Immune Support Supplement

Cannabinoid and co-active emulsion

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Agronomed LLC

UNKNOWN

Sponsor Role: collaborator

Center For Interventional Pain and Spine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philip Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Center For Interventional Pain and Spine

Locations

Center for Interventional Pain and Spine

Bryn Mawr, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Ashley M Scherer, MS

Role: CONTACT

ashleys@centerisp.com

3027503099

Facility Contacts

Ashley Scherer

Role: primary

Other Identifiers

CannabisforImmuneSupport

Identifier Type: -

Identifier Source: org_study_id