The IMPACT Registry
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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 |
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Recruitment Status :
Recruiting
First Posted : January 27, 2021
Last Update Posted : June 28, 2021
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| Condition or disease |
|---|
| Chronic Pain Appetite Disorders Neuropathy Menopausal Syndrome Anxiety Sleep Disturbance |
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:
- At the time patients first request and are recommended cannabis medicaments
- At various recommended and voluntary time points, collected via PRO surveys
- 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.
| 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 |
- 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
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.
| 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 |
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
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
| Contact: Mary Kay K Hardwick, MBA | 5106826256 | mkhardwick@tmebcn.com | |
| Contact: Peter Beitsch, MD | 214 350 6672 | pbeitsch@tmebcn.com |
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Other Publications:
| 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 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Dyssomnias Parasomnias Chronic Pain Feeding and Eating Disorders Pain |
Neurologic Manifestations Sleep Wake Disorders Nervous System Diseases Mental Disorders |