Commercially Available Cannabis Products for Immune Support

• ClinicalTrials.gov Identifier: NCT05944705
• Recruitment Status: Recruiting
• First Posted: July 13, 2023
• Last Update Posted: February 29, 2024
• Sponsor: Center For Interventional Pain and Spine
• Collaborator: Agronomed LLC
• Information provided by (Responsible Party): Center For Interventional Pain and Spine

Tracking Information

• First Submitted Date: February 20, 2023
• First Posted Date: July 13, 2023
• Last Update Posted Date: February 29, 2024
• Actual Study Start Date: November 1, 2023
• Estimated Primary Completion Date: November 1, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 6, 2023)

Adverse Events and Serious Adverse Eventss [ Time Frame: To Study Completion, approximately 30 days ]

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 6, 2023)

• Symptom Improvement [ Time Frame: 3 days ]
  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.
• Symptom Improvement [ Time Frame: 5 days ]
  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.
• Symptom Improvement [ Time Frame: 10 days ]
  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.
• Symptom Improvement [ Time Frame: 15 days ]
  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.
• Symptom Improvement [ Time Frame: 30 days ]
  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.
• Profile of Mood States (POMS) [ Time Frame: 3 days ]
  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.
• Profile of Mood States (POMS) [ Time Frame: 5 days ]
  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.
• Profile of Mood States (POMS) [ Time Frame: 10 days ]
  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.
• Profile of Mood States (POMS) [ Time Frame: 15 days ]
  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.
• Profile of Mood States (POMS) [ Time Frame: 30 days ]
  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.
• Quality of Life and Sleep via Patient-Reported Outcomes Measurement Information System (PROMIS-29) [ Time Frame: 3 days ]
  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.
• Quality of Life and Sleep via Patient-Reported Outcomes Measurement Information System (PROMIS-29) [ Time Frame: 5 days ]
  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.
• Quality of Life and Sleep via Patient-Reported Outcomes Measurement Information System (PROMIS-29) [ Time Frame: 10 days ]
  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.
• Quality of Life and Sleep via Patient-Reported Outcomes Measurement Information System (PROMIS-29) [ Time Frame: 15 days ]
  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.
• Quality of Life and Sleep via Patient-Reported Outcomes Measurement Information System (PROMIS-29) [ Time Frame: 30 days ]
  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.
• Time back to work/normal activities [ Time Frame: 3 days ]
  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.
• Time back to work/normal activities [ Time Frame: 5 days ]
  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.
• Time back to work/normal activities [ Time Frame: 10 days ]
  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.
• Time back to work/normal activities [ Time Frame: 15 days ]
  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.
• Time back to work/normal activities [ Time Frame: 30 days ]
  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.
• Concomitant medications and supplements [ Time Frame: To Study Completion, approximately 30 days ]
  All medications taken over the course of the study.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.

• Study Type: Observational
• Study Design: Observational Model: Case-Control; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Individuals who are suffering an acute illness

Condition

• Influenza
• COVID-19
• Common Cold

Intervention

Dietary Supplement: Immune Support Supplement

Cannabinoid and co-active emulsion

Study Groups/Cohorts

• 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
  Intervention: Dietary Supplement: Immune Support Supplement
• 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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: July 6, 2023): 200
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 1, 2024
• Estimated Primary Completion Date: November 1, 2024 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Ashley M Scherer, MS; 3027503099; ashleys@centerisp.com

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05944705
• Other Study ID Numbers: CannabisforImmuneSupport
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Center For Interventional Pain and Spine
• Original Responsible Party: Same as current
• Current Study Sponsor: Center For Interventional Pain and Spine
• Original Study Sponsor: Same as current
• Collaborators: Agronomed LLC

Investigators

• Principal Investigator: Philip Kim, MD; Center For Interventional Pain and Spine

• PRS Account: Center For Interventional Pain and Spine
• Verification Date: February 2024