We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The JULI Registry--Hemp and Cannabis Observational Registry (JULI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04726254
Recruitment Status : Recruiting
First Posted : January 27, 2021
Last Update Posted : July 19, 2022
Sponsor:
Collaborator:
Targeted Medical Education
Information provided by (Responsible Party):
Juva Life

Brief 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 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.

Condition or disease
Chronic Pain Appetite Disorders Neuropathy Menopausal Syndrome Anxiety Sleep Disturbance Nausea

Show Show detailed description

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Official Title: The JUvaLIfe Registry
Actual Study Start Date : August 1, 2021
Estimated Primary Completion Date : February 15, 2024
Estimated Study Completion Date : February 15, 2025

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Symptom Relief [ Time Frame: 3 months ]
    Percentage of patients who obtain and report symptom relief, by symptom, condition and cannabis formulation

  2. Reduction in reliance on Rx medications [ Time Frame: 3 months ]
    Percentage of patients who report reduction or increase in use of Rx medications


Secondary Outcome Measures :
  1. Reduction in reliance on OTC medications [ Time Frame: 3 months ]
    Percentage of patients who report reduction or increase in use of Rx medications



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Patient pregnant
  • Unwilling or unable to provide informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04726254


Contacts
Layout table for location contacts
Contact: Mary Kay K Hardwick, MBA 5106826256 mkhardwick@tmebcn.com
Contact: Peter Beitsch, MD 214 350 6672 pbeitsch@tmebcn.com

Locations
Layout table for location information
United States, California
Precision Cancer Specialists Recruiting
Los Gatos, California, United States, 95032
Contact: Rakesh Patel, MD    608-347-3405    medrockpatel@gmail.com   
Principal Investigator: Rakesh Patel, MD         
Justin Lo MD Recruiting
San Jose, California, United States, 95128
Contact: Justin Lo, MD    408-295-8628    justin@justinlomd.com   
United States, Tennessee
Nashville Breast Center Recruiting
Nashville, Tennessee, United States, 37203
Contact: Pat Whitworth, MD    615-620-5535    pwhitworth@tmebcn.com   
Contact: Kristie Appleton    615-620-5535      
United States, Texas
Dallas Surgical Group Recruiting
Dallas, Texas, United States, 75231
Contact: Peter Beitsch, MD    214-420-8499    pbeitsch@tmebcn.com   
Principal Investigator: Peter Beitsch, MD         
Sponsors and Collaborators
Juva Life
Targeted Medical Education
Publications of Results:
Other Publications:
Layout table for additonal information
Responsible Party: Juva Life
ClinicalTrials.gov Identifier: NCT04726254    
Other Study ID Numbers: JULI1000
First Posted: January 27, 2021    Key Record Dates
Last Update Posted: July 19, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Dyssomnias
Parasomnias
Chronic Pain
Feeding and Eating Disorders
Pain
Neurologic Manifestations
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders