Acute Effects of Cannabis and THC Oils on Cardiovascular Hemodynamics and Muscle Electrical Activity in Healthy Individuals: A Controlled Clinical Crossover Trial Protocol

TL;DR

This study examines how cannabis and THC oils affect heart function and muscle activity in healthy people through a controlled trial.

Contribution

The study introduces a controlled clinical protocol to assess dose-dependent effects of cannabis and THC oils on cardiovascular and muscular responses.

Findings

The study will measure changes in cardiovascular hemodynamics and muscle electrical activity after different doses of cannabis and THC oils.

It will provide insights into the dose–response relationship of cannabis and THC oils in healthy individuals.

The protocol may serve as a model for future research on cannabis effects.

Abstract

Background/Objectives: Cannabis sativa (CS) exerts its effects through the endocannabinoid system. Although studies have shown limited evidence regarding the plant’s therapeutic efficacy, little is known about the standardization of doses and their corresponding effects. This study aims to analyze changes in muscle electrical activity and cardiovascular hemodynamics before, during, and after administering doses of full-spectrum cannabis and tetrahydrocannabinol (THC) oils. Methods: Participants will be assigned to a single group that will undergo five different interventions: CBD + THC at 12.50 mg, CBD + THC at 18.75 mg, THC intervention at 12.50 mg, THC at 18.75 mg, and placebo intervention (PI). The study will enroll healthy, self-reported men and women aged 18 to 50, with no mental health disorders and no exposure to CS in the past six months. Interventions will occur on five randomized days, following three phases: (1) pre-intervention (PRE-IN); (2) intervention (IN)—1 h after oral oil ingestion; and (3) post-intervention (POST-IN)—2 h 30 min after ingestion. At each stage, 2 min of quiet breathing (QB); 2 min with an inspiratory resistance valve (30% of maximal inspiratory pressure—PImax) and expiratory valve (10% of maximal expiratory pressure—PEmax) (VAL); and 4 min of recovery without the valve (REC) were evaluated. Register: RBR-3jsvtbr. Conclusions: This study will enhance the understanding of the dose–response effects of full-spectrum cannabis and THC oils and may serve as a model for future research in this field.

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