Chronic PainJULINCT04726254
The JULI Registry--Hemp and Cannabis Observational Registry
An observational study of Chronic Pain and Appetite Disorders, run by Juva Life at 4 sites in United States.
Trial summary
The JuLi Registry seeks to fill some of the gaps associated with the clinical use of CBD (cannabidiol) and other cannabinoid formulations including THC and others. The overarching goal of this Registry is to rapidly advance research and understanding of the use of cannabis and hemp-based formulations, in the clinical… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Chronic Pain, Appetite Disorders, Neuropathy
- How many people
- 2,000 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Aug 2021to 15 Feb 2025
- How long will I take part?
- 3 Months
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients greater than or equal to 21 years of age who are seeking to use hemp-based or cannabis-based formulations to relieve symptoms associated with medical interventions or conditions
Who may be able to join
- 21 years of age or older
- Have requested from and/or decided with their providers to try CBD (hemp-based) or other cannabis products to relieve one or more symptoms related to a medical diagnosis
- Consent to have their health data included in a Registry and participate in PRO (patient reported outcomes) surveys and data collection via a study app.
Who cannot join
- Patient pregnant
- Unwilling or unable to provide informed consent
Trial locations and contacts
4 sites in 1 country.
United States4 sites, 4 recruiting
- Recruiting
Dallas Surgical Group
Dallas, Texas, 75231
Peter Beitsch, MD, 214-420-8499, pbeitsch@tmebcn.com
Peter Beitsch, MD
- Recruiting
Precision Cancer Specialists
Los Gatos, California, 95032
Rakesh Patel, MD, 608-347-3405, medrockpatel@gmail.com
Rakesh Patel, MD
- Recruiting
Nashville Breast Center
Nashville, Tennessee, 37203
Pat Whitworth, MD, 615-620-5535, pwhitworth@tmebcn.com
Kristie Appleton, 615-620-5535
- Recruiting
Justin Lo MD
San Jose, California, 95128
Justin Lo, MD, 408-295-8628, justin@justinlomd.com
About this study
Official title: The JUvaLIfe Registry
The JuLi Registry seeks to fill some of the gaps associated with the clinical use of CBD (cannabidiol) and other cannabinoid formulations including THC and others. The overarching goal of this Registry is to rapidly advance research and understanding of the use of cannabis and hemp-based formulations, in the clinical community setting, when it is utilized to manage the symptoms of cancer treatment and other underlying health issues. These symptoms include nausea, neuropathy, and sleeplessness and chronic pain.
Read the detailed description
The JuLi Registry seeks to fill some of the gaps associated with the clinical application of CBD (cannabidiol) and other cannabinoid formulations including THC and others. It will also serve as a platform for discovery, whereby observations of patient symptoms, specific cannabis formulations, delivery methods and clinical outcomes, become the source of more in-depth research projects.
The JuLi Registry is a prospective observational Registry documenting utility and patient experience for patients seeking to use therapeutic cannabis and hemp-based products as a means of symptom relief and management related to various diseases.
Targeted symptoms and conditions include:
- Chronic Pain
- Neuropathy
- Sleeplessness
- Poor Appetite
- Nausea
- Anxiety
- Menopausal symptoms
Data to be recorded includes:
- Basic demographics of patients using cannabis-based or hemp-based products
- Disease diagnoses and symptoms for which patients are seeking management
- Cannabinoid formulation, chemical composition, amount (in milligrams), dose and utilization
- Patient Reported Outcomes (PRO) using, where possible, validated measures of sleep, pain, appetite, etc.
- Physician and patient utilization of these data to manage prescription medication recommendations and usage, including discontinuation of opiates or reduction in use of opiates after initiation of cannabis- or hemp-based products
- Overall impact on clinical or patient treatment plan
The purpose of this Registry is to provide a platform for physicians and patients to collaborate on hemp and cannabis research and advance the understanding of the application of cannabinoids for symptom relief associated with various medical conditions.
Patients greater than or equal to 21 years of age seeking to use CBD or other cannabis-based formulations, where legal, will be invited to participate.
Data collected in the normal course of a patient's visit and follow up are entered. This is an observational study; no specific patient interventions are required. Patients must have requested a cannabis-based medicament from their provider. Or be otherwise deemed eligible per the research protocol and choose to participate in a self-directed manner.
Data will be collected at various time points, including:
- At the time patients first request cannabis or hemp based products
- At various recommended and voluntary time points, collected via PRO surveys
- Daily or whenever they are using their products via the use of a study app
- When patients return to their providers during the course of normal clinical care
All patients must sign an electronic informed consent form prior to their prospective data being entered into the Registry.
All demographic, diagnostic, hemp/cannabis formulation and follow up data will be entered by patients. Consented patients will record compliance with recommendations, usage and symptom relief. They will be asked to take symptom specific surveys.
- Conditions
- Chronic Pain, Appetite Disorders, Neuropathy, Menopausal Syndrome, Anxiety, Sleep Disturbance
- Medical subject headings
- Chronic Pain, Feeding and Eating Disorders, Anxiety Disorders, Parasomnias, Nausea
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom Relief
Percentage of patients who obtain and report symptom relief, by symptom, condition and cannabis formulation
Measured: 3 months
Reduction in reliance on Rx medications
Percentage of patients who report reduction or increase in use of Rx medications
Measured: 3 months
Secondary outcomes (1)
Reduction in reliance on OTC medications
Percentage of patients who report reduction or increase in use of Rx medications
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start1 Aug 2021
- Primary completion15 Feb 2024 (estimated)
- Study completion15 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Juva Life
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Targeted Medical Education
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04726254
- Sponsor's protocol ID
- JULI1000
- Acronym
- JULI
- Status last verified
- Jul 2022
- First submitted
- 24 Jan 2021
- Last updated
- 19 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zou S, Kumar U. Cannabinoid Receptors and the Endocannabinoid System: Signaling and Function in the Central Nervous System. Int J Mol Sci. 2018 Mar 13;19(3):833. doi: 10.3390/ijms19030833.
PubMed 29533978Freitas HR, Isaac AR, Malcher-Lopes R, Diaz BL, Trevenzoli IH, De Melo Reis RA. Polyunsaturated fatty acids and endocannabinoids in health and disease. Nutr Neurosci. 2018 Dec;21(10):695-714. doi: 10.1080/1028415X.2017.1347373. Epub 2017 Jul 7.
PubMed 28686542
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The JUvaLIfe Registry
- ClinicalTrials.gov ID
- NCT04726254
- Acronym / sponsor ID
- JULI / JULI1000
- Conditions
- Chronic Pain, Appetite Disorders, Neuropathy, Menopausal Syndrome, Anxiety, Sleep Disturbance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Juva LifeIndustry (pharma, biotech, devices)
- Collaborators
- Targeted Medical Education
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 15 Feb 2024 (estimated)
- Study completion
- 15 Feb 2025 (estimated)
- First posted
- 27 Jan 2021 (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.
The JuLi Registry seeks to fill some of the gaps associated with the clinical use of CBD (cannabidiol) and other cannabinoid formulations including THC and others. The overarching goal of this Registry is to rapidly advance research and understanding of the use of cannabis and hemp-based formulations, in the clinical community setting, when it is utilized to manage the symptoms of cancer treatment and other underlying health issues. These symptoms include nausea, neuropathy, and sleeplessness and chronic pain.
Detailed description
The JuLi Registry seeks to fill some of the gaps associated with the clinical application of CBD (cannabidiol) and other cannabinoid formulations including THC and others. It will also serve as a platform for discovery, whereby observations of patient symptoms, specific cannabis formulations, delivery methods and clinical outcomes, become the source of more in-depth research projects.
The JuLi Registry is a prospective observational Registry documenting utility and patient experience for patients seeking to use therapeutic cannabis and hemp-based products as a means of symptom relief and management related to various diseases.
Targeted symptoms and conditions include:
- Chronic Pain
- Neuropathy
- Sleeplessness
- Poor Appetite
- Nausea
- Anxiety
- Menopausal symptoms
Data to be recorded includes:
- Basic demographics of patients using cannabis-based or hemp-based products
- Disease diagnoses and symptoms for which patients are seeking management
- Cannabinoid formulation, chemical composition, amount (in milligrams), dose and utilization
- Patient Reported Outcomes (PRO) using, where possible, validated measures of sleep, pain, appetite, etc.
- Physician and patient utilization of these data to manage prescription medication recommendations and usage, including discontinuation of opiates or reduction in use of opiates after initiation of cannabis- or hemp-based products
- Overall impact on clinical or patient treatment plan
The purpose of this Registry is to provide a platform for physicians and patients to collaborate on hemp and cannabis research and advance the understanding of the application of cannabinoids for symptom relief associated with various medical conditions.
Patients greater than or equal to 21 years of age seeking to use CBD or other cannabis-based formulations, where legal, will be invited to participate.
Data collected in the normal course of a patient's visit and follow up are entered. This is an observational study; no specific patient interventions are required. Patients must have requested a cannabis-based medicament from their provider. Or be otherwise deemed eligible per the research protocol and choose to participate in a self-directed manner.
Data will be collected at various time points, including:
- At the time patients first request cannabis or hemp based products
- At various recommended and voluntary time points, collected via PRO surveys
- Daily or whenever they are using their products via the use of a study app
- When patients return to their providers during the course of normal clinical care
All patients must sign an electronic informed consent form prior to their prospective data being entered into the Registry.
All demographic, diagnostic, hemp/cannabis formulation and follow up data will be entered by patients. Consented patients will record compliance with recommendations, usage and symptom relief. They will be asked to take symptom specific surveys.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients greater than or equal to 21 years of age who are seeking to use hemp-based or cannabis-based formulations to relieve symptoms associated with medical interventions or conditions
Key inclusion criteria (3 listed)
- 21 years of age or older
- Have requested from and/or decided with their providers to try CBD (hemp-based) or other cannabis products to relieve one or more symptoms related to a medical diagnosis
- Consent to have their health data included in a Registry and participate in PRO (patient reported outcomes) surveys and data collection via a study app.
Key exclusion criteria (2 listed)
- Patient pregnant
- Unwilling or unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Symptom Relief
Time frame: 3 months
Percentage of patients who obtain and report symptom relief, by symptom, condition and cannabis formulation
Reduction in reliance on Rx medications
Time frame: 3 months
Percentage of patients who report reduction or increase in use of Rx medications
1 secondary outcome
Reduction in reliance on OTC medications
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2022.
- Background: PubMed 29533978Zou S, Kumar U. Cannabinoid Receptors and the Endocannabinoid System: Signaling and Function in the Central Nervous System. Int J Mol Sci. 2018 Mar 13;19(3):833. doi: 10.3390/ijms19030833.
- Results publication: PubMed 28686542Freitas HR, Isaac AR, Malcher-Lopes R, Diaz BL, Trevenzoli IH, De Melo Reis RA. Polyunsaturated fatty acids and endocannabinoids in health and disease. Nutr Neurosci. 2018 Dec;21(10):695-714. doi: 10.1080/1028415X.2017.1347373. Epub 2017 Jul 7.
- Individual participant dataSharing planned: Undecided
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain and Appetite Disorders, run by Juva Life at 4 sites 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 3 inclusion and 2 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 19 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 Mary Kay K Hardwick, MBA (5106826256, mkhardwick@tmebcn.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom Relief (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04726254, which also lists 2 linked publications.
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 19 Jul 2022.