INVESTIGATION
CLINICAL RESEARCH ON CANNABIS OIL
DOLOCANN CLINICAL TRIAL
Rationale for the study: Neuropathic pain poses a challenge due to the complexity of its etiology and pathogenesis and because approved therapies are not always effective. The endocannabinoid system is a potential target for the development of analgesics.
Objective: To evaluate the efficacy and safety of an oral cannabis formulation containing THC and CBD for the treatment of chronic neuropathic pain not associated with cancer.
Study population: Adult patients diagnosed with chronic neuropathic pain, under treatment by pain specialists at accredited healthcare centers in the Argentine province of Jujuy.
Ethical Approval: The research has been approved by the Provincial Committee on Health Research Ethics of the Ministry of Health of Jujuy. The research team is certified in good clinical practice (GCP) standards.
Methodology: Clinical data will be entered into a restricted-access digital database. Patients will complete validated questionnaires via the WhatsApp app to assess the efficacy, safety, and quality of life associated with THC and CBD therapy.
Evaluation: Anonymous data from the BPI, HADS, and EQ5D questionnaires, sleep quality assessments, records of adverse reactions, and concomitant medication records will be statistically analyzed in a digital database designed exclusively for this research. Additionally, adherence, dropout rates, and the feasibility of a registry and self-administered questionnaires in an original digital format will be measured.
Coordination: Cannava SE Medical Research Department, Principal Investigator: Dr. Carolina Ituarte, Collaborators: Dr. Francisco Lastiri and Pharmacy Technician Federico Segobia. Endorsed by the Ministry of Health of Jujuy, Argentina.
Status: Open study since July 2024.
CLINICAL RESEARCH ON CANNABIS OIL
PHARMACOVIGILANCE REGISTRY FOR CBD 10® IN REFRACTORY EPILEPSY
Rationale for the study: This is a Phase IV clinical pharmacovigilance study of a pharmaceutical product approved by Argentine health authorities, available exclusively in pharmacies by prescription.
Objectives: To assess the efficacy and safety of the pharmaceutical-grade cannabis derivative CBD10® (10% cannabidiol in oral formulation), approved as a medicinal product by the Ministry of Health of Jujuy and as a plant-based product by ANMAT (National Administration of Medicines, Food, and Technology) of Argentina.
Study population: patients, both adults and children, diagnosed with refractory epilepsy and treated with CBD10® prescribed by neurologists at the Arturo Zabala Hospital in Jujuy.
Methodology: Validated surveys were administered to all patients on a quarterly basis over a 2-year period, using a paper-based format. Anonymous clinical data were entered into a restricted-access digital database.
Evaluation: Data from the EQ-5D, CAVE, and QOLIE questionnaires, as well as records of adverse reactions and concomitant medications, entered into the digital database were analyzed using statistical methods.
Coordination: Medical Research Department of Cannava SE; Principal Investigator: Dr. Carolina Ituarte; Collaborators: Dr. Francisco Lastiri and Pharmacy Technician Federico Segobia. Endorsed by the Ministry of Health of the Province of Jujuy, Argentina.
Status: Study closed in March 2024; follow-up is planned to be completed for publication in scientific journals. From 2021 to 2024, more than 50 patients were enrolled in the registry; preliminary results indicate that CBD10® is a safe and effective medication for the treatment of refractory epilepsy under medical prescription, with a trend toward reduced use of concomitant medications.
CLINICAL RESEARCH ON CANNABIS OIL
A STUDY OF THE EFFECTS OF PHYTO-CANNABINOIDS IN AN EXPERIMENTAL MODEL OF NEUROPATHIC PAIN INDUCED BY CHEMOTHERAPY DRUGS
Rationale for the study: Chemotherapy involves the use of drugs to treat cancer. To date, there are no effective treatments for neuropathy caused by chemotherapy agents. This limits treatment options and prognosis for people with cancer.
Objectives: To evaluate different cannabis formulations, containing THC and CBD, for the treatment of chemotherapy-induced neurotoxicity.
Study population: This is a preclinical study in animals, using experimental models in mice.
Methodology: To evaluate the efficacy and safety of a THC and CBD therapy for the treatment of chemotherapy-induced neurotoxicity.
Coordination: Cancer-Associated Pain Laboratory at the Institute for Translational Medicine Research at Austral University and CONICET (National Scientific and Technical Research Council) of Argentina; Principal Investigator: Dr. Florencia Coronel. With the endorsement and collaboration of Cannava SE through the provision of cannabis derivatives.
Status: Study completed in 2024; results are scheduled for publication in scientific journals.
CLINICAL RESEARCH WITH CANNABIS OIL
STUDY OF EXPERIMENTAL TREATMENTS FOR PERIODONTAL DISEASE BASED ON MODULATION OF THE ENDOCANNABINOID SYSTEM AND THE APPLICATION OF CANNABIDIOL
Justification for the study: Periodontal disease is an oral infection that deteriorates the attachment of teeth. It affects 14% of the world's population and progresses with tooth loss, impairing oral health and the quality of life of those affected.
Objectives: To assess the anti-inflammatory and osteoprotective effect of a CBD gel through pharmacological modulation of the endocannabinoid system to treat periodontal disease and to lay the foundations for its future application in humans.
Study population: This is a preclinical study in animals, mice with experimental periodontitis.
Methodology: to assess the effectiveness of gingival CBD application in rats during the pre and post periodontal disease time periods and compare them with a control group treated with placebo.
Coordination: Cannabis Research and Therapeutic Use Unit, Dentistry Area, Chair of Human Physiology, Faculty of Dentistry, University of Buenos Aires (UBA) and CONICET of Argentina, responsible Drs. José Javier Fernández Solari and Vanesa Macri. With the collaboration of Cannava Sociedad Estatal through the provision of cannabis derivatives.