Friday, May 10, 2019

Just Released: Multistate, Multicenter Clinical Study For The Efficacy and Safety of Medical Cannabis Needs 10,000 Participants

ClinicalTrials.gov

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.

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.

Conditions or diseases to be studied with medical cannabis use:
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

Eligibility Criteria:
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

ClinicalTrials.gov

To Learn More About This Study or To Enroll In ClinicalTrials.gov Identifier: NCT03944447 Click Link Here: 
Outcomes Mandate National Integration With Cannabis as Medicine (OMNI-Can)


No comments:

Post a Comment