ACUTE EFFECTS OF DIFFERENT DOSES OF FULL SPECTRUM CANNABIS OILS AND ISOLATED THC ON CARDIOVASCULAR HEMODYNAMICS AND MUSCLE ELECTRICAL ACTIVITY IN HEALTHY INDIVIDUALS: A CONTROLLED CROSSOVER CLINICAL TRIAL
Cannabis Sativa; endocannabinoid; cardiorespiratory hemodynamics; Randomized controlled tria
Introduction: Cannabis Sativa (CS) exerts its effects through the endocannabinoid system. Although some studies have demonstrated the therapeutic efficacy of the plant, there is still little understanding of dose systematization and its effects. Therefore, this study aims to analyze modifications in muscle electrical activity and cardiovascular hemodynamics before, during, and after administration of doses of full spectrum cannabis oil and THC. Methods: Individuals will be allocated to a single group participating in five distinct interventions: Full Spectrum intervention at 12.50 mg (I-fs/12.50mg), Full Spectrum intervention at 18.65 mg (I-fs/18.65mg), THC intervention at 12.50 mg (I-THC/12.50mg), THC intervention at 18.65 mg (I-THC/18.65mg), and placebo intervention (IP). Men and women aged 18 to 50 years, self-declared healthy, without psychological disorders, and who have not been exposed to CS in the last 6 months will be included in the study. Interventions will occur on five days in a randomized manner and wil follow three stages: 1-Pre-Intervention (PRE-in); 2-Intervention (IN) - 1h after oral oil ingestion; and 3-Post-Intervention (POST-in) - 2h30 after ingestion. At each stage, 2 minutes of spontaneous breathing (QB), 2 minutes with inspiratory (30% of PImax) and expiratory (10% of PEmax) resistance valve (VAL), and concluding with 4 minutes of recovery without the valve (REC) will be evaluated. Conclusion: This study will contribute to understanding the dose-response effects of both Full Spectrum oil and THC, as well as serve as a model for other studies in the field.