Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT04726254
Previous Study | Return to List | Next Study

The IMPACT Registry

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 : June 28, 2021
Sponsor:
Collaborator:
Targeted Medical Education
Information provided by (Responsible Party):
Juva Life

Brief Summary:
The IMPACT 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, in the clinical community setting, when it is utlized 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

Detailed Description:

The IMPACT 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 IMPACT Registry is a prospective observational Registry documenting utility and patient experience for patients seeking to use therapeutic cannabis medicaments 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 medicaments
  • 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-based medicaments
  • 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 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 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 and recommendation from their provider.

Data will be collected at various time points, including:

  1. At the time patients first request and are recommended cannabis medicaments
  2. At various recommended and voluntary time points, collected via PRO surveys
  3. When patients return to their providers during the course of normal clinical care

All patients must sign a paper or electronic informed consent form prior to their prospective data being entered into the Registry.

All demographic, diagnostic, cannabis formulation and follow up data will be entered by participating providers. Consented patients will record compliance with recommendations, usage and symptom relief. They will be asked to take symptom specific surveys, if applicable.

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Informed Patient Cannabis Therapy Registry
Estimated 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: 12 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: 12 months ]
    Reduction in reliance on 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 cannabis formulations to relieve symptoms associated with medical interventions
Criteria

Inclusion Criteria:

  • 21 years of age or older
  • Have requested from and/or decided with their providers to try CBD or other cannabis medicaments 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 surveys

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         
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: IMPACT1000
First Posted: January 27, 2021    Key Record Dates
Last Update Posted: June 28, 2021
Last Verified: June 2021
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