InfluenzaNCT05944705
Commercially Available Cannabis Products for Immune Support
An observational study of Influenza and COVID-19, run by Center For Interventional Pain and Spine at 1 site in United States.
Trial summary
This study will be a prospective observation of the use of commercially available hemp and cannabis products marketed for immune support. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza, COVID-19, Common Cold
- What is being tested?
- Immune Support Supplement
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2023to 1 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals who are suffering an acute illness
Who may be able to join
- 18 years of age or older
- Able to read and write in English
- Active participants in the Pennsylvania medical marijuana program (for cannabis product users)
- Currently experiencing one or more of the following symptoms due to an acute illness:
- Fever or chills
- Cough
Show all 17Show fewer
- Fatigue
- Muscle or body aches
- Headache
- Sore throat
- Congestion or runny nose
- Nausea or Vomiting
- Diarrhea
- 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
- Agrees to continue to abstain from using hemp or cannabis (for the non-cannabis/hemp using arm)
- Must have smart phone or email and access to the internet
- Be able to comply with study requirements including baseline, completion of electronic questionnaires, and study timeline parameters.
Who cannot join
- Women who are pregnant, breastfeeding, or planning to become pregnant.
- Known allergy to any compounds in hemp or cannabis.
- Endorses suicidal intent
- Immunocompromised individuals
- Unwilling or unable to comply with study procedures
- Terminal Illness with life expectancy less than 1 year
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Center for Interventional Pain and Spine
Bryn Mawr, Pennsylvania, 19010
Ashley Scherer
About this study
Official title: Commercially Available Cannabis (Hemp) Products for Immune Support: A Prospective Observational Study to Evaluate Safety and Effects
This study will be a prospective observation of the use of commercially available hemp and cannabis products marketed for immune support.
Read the 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
- Being tested
- Immune Support Supplement
- Medical subject headings
- Influenza, Human, COVID-19, Common Cold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immune Support SupplementDietary supplement
Cannabinoid and co-active emulsion
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: To Study Completion, approximately 30 days
Secondary outcomes (21)
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.
Measured: 3 days
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.
Measured: 5 days
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.
Measured: 10 days
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.
Measured: 15 days
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.
Measured: 30 days
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.
Measured: 3 days
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.
Measured: 5 days
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.
Measured: 10 days
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.
Measured: 15 days
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.
Measured: 30 days
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.
Measured: 3 days
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.
Measured: 5 days
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.
Measured: 10 days
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.
Measured: 15 days
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.
Measured: 30 days
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.
Measured: 3 days
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.
Measured: 5 days
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.
Measured: 10 days
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.
Measured: 15 days
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.
Measured: 30 days
Concomitant medications and supplements
All medications taken over the course of the study.
Measured: To Study Completion, approximately 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study start1 Nov 2023
- Primary completion1 Nov 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Center For Interventional Pain and Spine
- Sponsor type
- University, hospital or other
- Collaborators
- Agronomed LLC
- Responsible party
- Sponsor
- Investigators
- Philip Kim, MD, Principal investigator, Center For Interventional Pain and Spine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05944705
- Sponsor's protocol ID
- CannabisforImmuneSupport
- Status last verified
- Feb 2024
- First submitted
- 20 Feb 2023
- Last updated
- 29 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Commercially Available Cannabis (Hemp) Products for Immune Support: A Prospective Observational Study to Evaluate Safety and Effects
- ClinicalTrials.gov ID
- NCT05944705
- Acronym / sponsor ID
- CannabisforImmuneSupport
- Conditions
- Influenza, COVID-19, Common Cold
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Center For Interventional Pain and SpineUniversity, hospital or other
- Collaborators
- Agronomed LLC
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 13 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Symptomatic individuals using hemp or cannabis products for immune support | – | Dietary Supplement: Immune Support SupplementIndividuals with symptomatic illness that utilize a proprietary hemp or cannabis product to aid in their recovery |
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals who are suffering an acute illness
Key inclusion criteria (17 listed)
- 18 years of age or older
- Able to read and write in English
- Active participants in the Pennsylvania medical marijuana program (for cannabis product users)
- Currently experiencing one or more of the following symptoms due to an acute illness:
- 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
Key exclusion criteria (6 listed)
- Women who are pregnant, breastfeeding, or planning to become pregnant.
- Known allergy to any compounds in hemp or cannabis.
- Endorses suicidal intent
- Immunocompromised individuals
- Unwilling or unable to comply with study procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immune Support SupplementCannabinoid and co-active emulsion | Dietary supplement | Symptomatic individuals using hemp or cannabis products for immune support |
Primary outcome
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
21 secondary outcomes
Symptom Improvement
Time frame: 3 days
Symptom Improvement
Time frame: 5 days
Symptom Improvement
Time frame: 10 days
Symptom Improvement
Time frame: 15 days
Symptom Improvement
Time frame: 30 days
Profile of Mood States (POMS)
Time frame: 3 days
Profile of Mood States (POMS)
Time frame: 5 days
Profile of Mood States (POMS)
Time frame: 10 days
Profile of Mood States (POMS)
Time frame: 15 days
Profile of Mood States (POMS)
Time frame: 30 days
Quality of Life and Sleep via Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Time frame: 3 days
Quality of Life and Sleep via Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Time frame: 5 days
Quality of Life and Sleep via Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Time frame: 10 days
Quality of Life and Sleep via Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Time frame: 15 days
Quality of Life and Sleep via Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Time frame: 30 days
Time back to work/normal activities
Time frame: 3 days
Time back to work/normal activities
Time frame: 5 days
Time back to work/normal activities
Time frame: 10 days
Time back to work/normal activities
Time frame: 15 days
Time back to work/normal activities
Time frame: 30 days
Concomitant medications and supplements
Time frame: To Study Completion, approximately 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip Kim, MD principal investigator
Center For Interventional Pain and Spine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Influenza and COVID-19, run by Center For Interventional Pain and Spine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ashley M Scherer, MS (3027503099, ashleys@centerisp.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events and Serious Adverse Eventss (time frame: To Study Completion, approximately 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2024.