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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

Tracking Information
First Submitted Date January 24, 2021
First Posted Date January 27, 2021
Last Update Posted Date July 19, 2022
Actual Study Start Date August 1, 2021
Estimated Primary Completion Date February 15, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 15, 2022)
  • 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
Original Primary Outcome Measures
 (submitted: January 24, 2021)
  • Symptom Relief [ Time Frame: 12 months ]
    • Percentage of patients who obtain and report symptom relief, by symptom, condition and cannabis formulation
  • Reduction in reliance on Rx medications [ Time Frame: 12 months ]
    Reduction in reliance on Rx medications
Change History
Current Secondary Outcome Measures
 (submitted: July 15, 2022)
Reduction in reliance on OTC medications [ Time Frame: 3 months ]
Percentage of patients who report reduction or increase in use of Rx medications
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The JULI Registry--Hemp and Cannabis Observational Registry
Official Title The JUvaLIfe Registry
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.
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:

  1. At the time patients first request cannabis or hemp based products
  2. At various recommended and voluntary time points, collected via PRO surveys
  3. Daily or whenever they are using their products via the use of a study app
  4. 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 Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 3 Months
Biospecimen Not Provided
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
Condition
  • Chronic Pain
  • Appetite Disorders
  • Neuropathy
  • Menopausal Syndrome
  • Anxiety
  • Sleep Disturbance
  • Nausea
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 24, 2021)
2000
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 15, 2025
Estimated Primary Completion Date February 15, 2024   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Mary Kay K Hardwick, MBA 5106826256 mkhardwick@tmebcn.com
Contact: Peter Beitsch, MD 214 350 6672 pbeitsch@tmebcn.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04726254
Other Study ID Numbers JULI1000
Has Data Monitoring Committee No
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: Undecided
Current Responsible Party Juva Life
Original Responsible Party Targeted Medical Education
Current Study Sponsor Juva Life
Original Study Sponsor Targeted Medical Education
Collaborators Targeted Medical Education
Investigators Not Provided
PRS Account Juva Life
Verification Date July 2022