An observational study in Influenza, COVID-19 and Common Cold, sponsored by Center For Interventional Pain and Spine. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-29.
Sponsored by Center For Interventional Pain and Spine · Observational
This study will be a prospective observation of the use of commercially available hemp and cannabis products marketed for immune support.
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.
2,356 studies on the registry are indexed under Influenza, Human; 184 are open to participants now.
This study's planned enrollment of 200 is below the median of 388 across 332 observational studies indexed under Influenza, Human.
Browse Influenza, Human studies →Center For Interventional Pain and Spine is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Individuals who are suffering an acute illness
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Currently experiencing one or more of the following symptoms due to an acute illness:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Individuals with symptomatic illness that utilize a proprietary hemp or cannabis product to aid in their recovery
Dietary Supplement: Immune Support Supplement
Individuals without symptomatic illness that do not utilize the proprietary hemp or cannabis product to aid in their recovery
Cannabinoid and co-active emulsion
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
Time frame: To Study Completion, approximately 30 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 30 days
Concomitant medications and supplements
All medications taken over the course of the study.
Time frame: To Study Completion, approximately 30 days
Plan to share: No
No publications or documents are linked to this record.
Started Nov 2023 (actual). Primary completion is estimated for Nov 2024, 12 months after the start.
Of 96 non-industry observational studies under Influenza, Human, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 92. This study's planned 12 months is below that.
Counting every sponsor, half of 133 studies reached it within 21 months; a quarter within 7 and three quarters within 59.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Center For Interventional Pain and Spine