Commercially Available Cannabis Products for Immune Support

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05944705
• Other study ID #: CannabisforImmuneSupport
• Status: Recruiting
• Start date: November 1, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: February 2024
• Source: Center For Interventional Pain and Spine
• Contact: Ashley M Scherer, MS
• Phone: 3027503099
• Email: ashleys[@]centerisp.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 1, 2024
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Common Cold
• COVID-19
• Influenza

Intervention

Dietary Supplement:
• Immune Support Supplement
Cannabinoid and co-active emulsion

Locations

Country	Name	City	State
United States	Center for Interventional Pain and Spine	Bryn Mawr	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Center For Interventional Pain and Spine	Agronomed LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events and Serious Adverse Eventss	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	To Study Completion, approximately 30 days
Secondary	Symptom Improvement	Quantify subject-reported changes in symptoms during the course of their illness at baseline, 3-, 5-, 10- 15- and 30-days via electronic survey collection.	3 days
Secondary	Symptom Improvement	Quantify subject-reported changes in symptoms during the course of their illness at baseline, 3-, 5-, 10- 15- and 30-days via electronic survey collection.	5 days
Secondary	Symptom Improvement	Quantify subject-reported changes in symptoms during the course of their illness at baseline, 3-, 5-, 10- 15- and 30-days via electronic survey collection.	10 days
Secondary	Symptom Improvement	Quantify subject-reported changes in symptoms during the course of their illness at baseline, 3-, 5-, 10- 15- and 30-days via electronic survey collection.	15 days
Secondary	Symptom Improvement	Quantify subject-reported changes in symptoms during the course of their illness at baseline, 3-, 5-, 10- 15- and 30-days via electronic survey collection.	30 days
Secondary	Profile of Mood States (POMS)	The Profile of Mood States is a subject-reported questionnaire that measures the six different dimensions of mood swings. These dimensions include tension or anxiety, anger or hostility, vigor or activity, fatigue or inertia, depression or dejection, confusion or bewilderment. This scale contains 65 self-report items using the 5-point Likert Scale. Participants can choose from 0 (not at all) to 4 (extremely). Higher scores on the POMS subscales reflect a greater agreement with the mood state during the past week.	3 days
Secondary	Profile of Mood States (POMS)	The Profile of Mood States is a subject-reported questionnaire that measures the six different dimensions of mood swings. These dimensions include tension or anxiety, anger or hostility, vigor or activity, fatigue or inertia, depression or dejection, confusion or bewilderment. This scale contains 65 self-report items using the 5-point Likert Scale. Participants can choose from 0 (not at all) to 4 (extremely). Higher scores on the POMS subscales reflect a greater agreement with the mood state during the past week.	5 days
Secondary	Profile of Mood States (POMS)	The Profile of Mood States is a subject-reported questionnaire that measures the six different dimensions of mood swings. These dimensions include tension or anxiety, anger or hostility, vigor or activity, fatigue or inertia, depression or dejection, confusion or bewilderment. This scale contains 65 self-report items using the 5-point Likert Scale. Participants can choose from 0 (not at all) to 4 (extremely). Higher scores on the POMS subscales reflect a greater agreement with the mood state during the past week.	10 days
Secondary	Profile of Mood States (POMS)	The Profile of Mood States is a subject-reported questionnaire that measures the six different dimensions of mood swings. These dimensions include tension or anxiety, anger or hostility, vigor or activity, fatigue or inertia, depression or dejection, confusion or bewilderment. This scale contains 65 self-report items using the 5-point Likert Scale. Participants can choose from 0 (not at all) to 4 (extremely). Higher scores on the POMS subscales reflect a greater agreement with the mood state during the past week.	15 days
Secondary	Profile of Mood States (POMS)	The Profile of Mood States is a subject-reported questionnaire that measures the six different dimensions of mood swings. These dimensions include tension or anxiety, anger or hostility, vigor or activity, fatigue or inertia, depression or dejection, confusion or bewilderment. This scale contains 65 self-report items using the 5-point Likert Scale. Participants can choose from 0 (not at all) to 4 (extremely). Higher scores on the POMS subscales reflect a greater agreement with the mood state during the past week.	30 days
Secondary	Quality of Life and Sleep via Patient-Reported Outcomes Measurement Information System (PROMIS-29)	The Subject-Reported Outcomes Measurement Information System is a questionnaire that assesses pain intensity in addition to several correlating domains of health. The domains of health assessed include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. The patients' answers to the PROMIS-29 are scored from 1-5 (with the exception of the NRS). The sum of the PROMIS results in the raw score, which lies between 4 and 20. There is no total score, but each axis forms its own score.	3 days
Secondary	Quality of Life and Sleep via Patient-Reported Outcomes Measurement Information System (PROMIS-29)	The Subject-Reported Outcomes Measurement Information System is a questionnaire that assesses pain intensity in addition to several correlating domains of health. The domains of health assessed include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. The patients' answers to the PROMIS-29 are scored from 1-5 (with the exception of the NRS). The sum of the PROMIS results in the raw score, which lies between 4 and 20. There is no total score, but each axis forms its own score.	5 days
Secondary	Quality of Life and Sleep via Patient-Reported Outcomes Measurement Information System (PROMIS-29)	The Subject-Reported Outcomes Measurement Information System is a questionnaire that assesses pain intensity in addition to several correlating domains of health. The domains of health assessed include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. The patients' answers to the PROMIS-29 are scored from 1-5 (with the exception of the NRS). The sum of the PROMIS results in the raw score, which lies between 4 and 20. There is no total score, but each axis forms its own score.	10 days
Secondary	Quality of Life and Sleep via Patient-Reported Outcomes Measurement Information System (PROMIS-29)	The Subject-Reported Outcomes Measurement Information System is a questionnaire that assesses pain intensity in addition to several correlating domains of health. The domains of health assessed include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. The patients' answers to the PROMIS-29 are scored from 1-5 (with the exception of the NRS). The sum of the PROMIS results in the raw score, which lies between 4 and 20. There is no total score, but each axis forms its own score.	15 days
Secondary	Quality of Life and Sleep via Patient-Reported Outcomes Measurement Information System (PROMIS-29)	The Subject-Reported Outcomes Measurement Information System is a questionnaire that assesses pain intensity in addition to several correlating domains of health. The domains of health assessed include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. The patients' answers to the PROMIS-29 are scored from 1-5 (with the exception of the NRS). The sum of the PROMIS results in the raw score, which lies between 4 and 20. There is no total score, but each axis forms its own score.	30 days
Secondary	Time back to work/normal activities	Average time back to work/normal activities will be measured by collecting the day at which the individual became ill and missed work/normal activities and collecting the day at which work/normal activities will be resumed.	3 days
Secondary	Time back to work/normal activities	Average time back to work/normal activities will be measured by collecting the day at which the individual became ill and missed work/normal activities and collecting the day at which work/normal activities will be resumed.	5 days
Secondary	Time back to work/normal activities	Average time back to work/normal activities will be measured by collecting the day at which the individual became ill and missed work/normal activities and collecting the day at which work/normal activities will be resumed.	10 days
Secondary	Time back to work/normal activities	Average time back to work/normal activities will be measured by collecting the day at which the individual became ill and missed work/normal activities and collecting the day at which work/normal activities will be resumed.	15 days
Secondary	Time back to work/normal activities	Average time back to work/normal activities will be measured by collecting the day at which the individual became ill and missed work/normal activities and collecting the day at which work/normal activities will be resumed.	30 days
Secondary	Concomitant medications and supplements	All medications taken over the course of the study.	To Study Completion, approximately 30 days