Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 14 of 155 for:    (Dementia pugilistica OR chronic traumatic encephalopathy)

Outcomes Mandate National Integration With Cannabis as Medicine (OMNI-Can)

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: NCT03944447
Recruitment Status : Recruiting
First Posted : May 9, 2019
Last Update Posted : June 19, 2019
Sponsor:
Information provided by (Responsible Party):
OMNI Medical Services, LLC

Brief Summary:
This will be a multistate, multicenter clinical study to determine the efficacy and safety of medical cannabis for a wide variety of chronic medical conditions.

Condition or disease Intervention/treatment
Chronic Pain Chronic Pain Syndrome Chronic Pain Due to Injury Chronic Pain Due to Trauma Fibromyalgia Seizures Hepatitis C Cancer Crohn Disease HIV/AIDS Multiple Sclerosis Traumatic Brain Injury Sickle Cell Disease Post Traumatic Stress Disorder Tourette Syndrome Ulcerative Colitis Glaucoma Epilepsy Inflammatory Bowel Diseases Parkinson Disease Amyotrophic Lateral Sclerosis Chronic Traumatic Encephalopathy Anxiety Depression Insomnia Autism Opioid-use Disorder Drug: Cannabis, Medical

Detailed Description:

Medical cannabis has been legal in parts of the USA since 1996, with the stated intention of reducing pain (both acute and chronic) as well as for treatment of multiple other conditions. The original implementation of medical cannabis in the USA was implemented in California as a compassionate measure to treat the HIV/AIDS epidemic. Additional studies have shown promising outcome for patients with multiple sclerosis, seizures, cancer, and other chronic conditions. However, there have been few comprehensive studies that have actually measured whether cannabis is an effective treatment for pain reduction. There is an absence of multistate, multicenter clinical studies with cannabis as medicine, not only in the USA but globally. With the expansion of medical cannabis into more than 38 states in the US, this type of clinical study is now feasible.

This study will utilize an anonymous novel online questionnaire to determine study participants' qualifying condition(s) for medical cannabis use, cannabis ingestion method, frequency of use, prescription drug use, and demographic information. Secondary factors will include evaluation of pain control, quality of life metrics, any adverse side effects from cannabis use, as well as changes in adjunctive treatments. Patients will be given medical cannabis recommendations and certifications commensurate with the state law in which the encounter occurs. The variations in mechanisms between the states for recommending, registering, certifying, and developing mandated treatment plans or doses will be adhered to; however, variations in state law and cannabis programs should not cause variation in the study design because the end-result is still the same with patients being treated with medical cannabis.


Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Outcomes Mandate National Integration With Cannabis as Medicine
Actual Study Start Date : December 1, 2018
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

Group/Cohort Intervention/treatment
Cannabis users
Most patients will have used cannabis before their initial physician visit, and many current patients will be returning for an in-person follow-up. Patients will be given the survey shortly after the physician encounter to assess baseline parameters with current cannabis use. Any patient who is "cannabis-naïve", defined as no use within the past year or longer, will be placed into a separate data analysis arm. The investigators will follow up with patients again at 3, 6, 9, and 12 months with the online survey. Patients returning for their annual physician encounter will continue on the 3-month survey schedule until the end of the study, or if lost to follow-up. There may be slight variations in the interval based on state law, for example in Florida the in-person follow-up with the physician is required every 210 days, and some states allow for 2 year in-person visits. Every attempt will be made to adhere to a 3-month interval survey distribution.
Drug: Cannabis, Medical
Patients will be given medical cannabis recommendations and certifications commensurate with the state law in which the encounter occurs. The variations in mechanisms between the states for recommending, registering, certifying, and developing mandated treatment plans or doses will be adhered to; however, variations in state law and cannabis programs should not cause variation in the study design because the end-result is still the same with patients being treated with medical cannabis.
Other Names:
  • Marijuana Medical
  • Marijuana Treatment




Primary Outcome Measures :
  1. Treatment of Symptoms [ Time Frame: Five years ]
    The primary objective is to assess the efficacy and safety of medical cannabis as medicine for treatment of chronic pain and other chronic debilitating diseases. Pain will be measured by Brief Pain Inventory (BPI) numeric scale. Change from baseline in BPI will be assessed at 3-month intervals. For prospective associations between cannabis use and outcomes, use of a lagged mixed-effects models will examine temporal associations between cannabis use and pain severity, opioid sparing, and patient satisfaction. Data will be analyzed from baseline and the annual follow-up waves.

  2. Monitoring Adverse Events [ Time Frame: Five years ]
    Incidence of Treatment-Related Adverse Events will be measured by Physician Global Assessment (PGA) numeric scale. Number of participants with Treatment-Related Adverse Events will be assessed by CTCAE v4.0.


Secondary Outcome Measures :
  1. Cannabis Impact on Quality of Life [ Time Frame: Five years ]
    Secondary objectives include evaluating increases or decreases in quality of life, and increases or decreases in concomitant opioid use. Satisfaction with treatment will be measured by a Visual Analog Score (VAS). Change From baseline in Satisfaction with treatment measured by (VAS) be assessed at 3-month intervals.

  2. Cannabis Route and Dosing [ Time Frame: Five years ]
    Tertiary objectives will examine preferences for routes of administration, and preferences for THC / CBD ratios. Categorical factors will be summarized using frequencies and percentages, while continuous measure distributions will be described using means, standard deviations, and quartiles of interest.



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:   7 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Surveys will be administered to legal medical cannabis patients of OMNI Medical facilities conducting clinical research in multiple states in clinical research centers, with expansion to other states as medical cannabis laws permit.
Criteria

Inclusion Criteria:

  • Clinical diagnosis of a Qualifying Condition for Medical Marijuana
  • Must be 18 years or older unless they have consent from their parent or legal guardian as defined under state law parameters
  • Must be willing to complete online surveys at baseline and the follow up points in this study

Exclusion Criteria:

  • None

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): NCT03944447


Contacts
Layout table for location contacts
Contact: Ryan O Lakin, MD JD 419-214-3220 ryan.lakin.md@gmail.com

Locations
Layout table for location information
United States, Florida
OMNI Medical Services Recruiting
Boca Raton, Florida, United States, 33433
Contact: Ryan O Lakin, MD JD    888-470-0008      
OMNI Medical Services Recruiting
Bradenton, Florida, United States, 34209
Contact: Ryan O Lakin, MD JD    888-470-0008      
OMNI Medical Services Recruiting
Fort Lauderdale, Florida, United States, 33308
Contact: Ryan O Lakin, MD JD    888-470-0008      
OMNI Medical Services Recruiting
Fort Myers, Florida, United States, 34135
Contact: Ryan O Lakin, MD JD    888-470-0008      
OMNI Medical Services Recruiting
Gainesville, Florida, United States, 36201
Contact: Ryan O Lakin, MD JD    888-470-0008      
OMNI Medical Services Recruiting
Merritt Island, Florida, United States, 32952
Contact: Ryan O Lakin, MD JD    888-470-0008      
OMNI Medical Services Recruiting
Miami, Florida, United States, 33137
Contact: Ryan O Lakin, MD JD    888-470-0008      
OMNI Medical Services Recruiting
Ocoee, Florida, United States, 34761
Contact: Ryan O Lakin, MD JD    888-470-0008      
OMNI Medical Services Recruiting
Pensacola, Florida, United States, 32505
Contact: Ryan O Lakin, MD JD    888-470-0008      
OMNI Medical Services Recruiting
Pompano Beach, Florida, United States, 33060
Contact: Ryan O Lakin, MD JD    888-470-0008      
OMNI Medical Services Recruiting
Tampa, Florida, United States, 33614
Contact: Ryan O Lakin, MD JD    888-470-0008      
OMNI Medical Services Recruiting
Wesley Chapel, Florida, United States, 33544
Contact: Ryan O Lakin, MD JD    888-470-0008      
United States, Ohio
OMNI Medical Services Recruiting
Beechwood, Ohio, United States, 44122
Contact: Ryan O Lakin, MD JD    888-470-0008      
OMNI Medical Services Recruiting
Bowling Green, Ohio, United States, 43402
Contact: Ryan O Lakin, MD JD    888-470-0008      
OMNI Medical Services Recruiting
Sandusky, Ohio, United States, 44870
Contact: Ryan O Lakin, MD JD    888-470-0008      
OMNI Medical Services Recruiting
Toledo, Ohio, United States, 43604
Contact: Ryan O Lakin, MD JD    419-214-3220      
OMNI Medical Services Recruiting
Toledo, Ohio, United States, 43611
Contact: Ryan O Lakin, MD JD    888-470-0008      
Sponsors and Collaborators
OMNI Medical Services, LLC
Investigators
Layout table for investigator information
Principal Investigator: Ryan O Lakin, MD JD OMNI Medical Services

Additional Information:
Layout table for additonal information
Responsible Party: OMNI Medical Services, LLC
ClinicalTrials.gov Identifier: NCT03944447     History of Changes
Other Study ID Numbers: Pro00033337
First Posted: May 9, 2019    Key Record Dates
Last Update Posted: June 19, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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
Chronic Pain
Brain Injuries, Traumatic
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Chronic Traumatic Encephalopathy
Brain Injury, Chronic
Disease
Syndrome
Wounds and Injuries
Sclerosis
Parkinson Disease
Hepatitis C
Multiple Sclerosis
Brain Injuries
Crohn Disease
Colitis, Ulcerative
Seizures
Fibromyalgia
Inflammatory Bowel Diseases
Anemia, Sickle Cell
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Brain Diseases
Tourette Syndrome
Pathologic Processes
Parkinsonian Disorders
Basal Ganglia Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders