The Behavioral Neuroscience Laboratory (LabNeC) at the University of Southern Santa Catarina (UNISUL) is expanding its lines of investigation into the medicinal use of the plant. Under the coordination of Prof. Dr. Rafael Mariano de Bitencourt, the institution is preparing a series of new randomized double-blind clinical trials with cannabis.

The research aims to evaluate the efficacy of phytocannabinoids in conditions such as Attention Deficit Hyperactivity Disorder (ADHD), depression, and neuropathic wounds. Scheduled to begin between March and April of this year, the studies involve partnerships with patient associations and other academic institutions.

Unlike previous observational studies, the new initiatives aim to isolate variables to ensure more robust data. A highlight is the study focused on adolescents with ADHD, pioneering the controlled use of Cannabigerol (CBG), which will be conducted in the Florianópolis region.

"There is practically no double-blind clinical trial with CBG and ADHD. It will be an interesting study because it is not a shot in the dark. We combine theoretical knowledge with off-label clinical practice," explains Bitencourt.

Methodology of clinical trials with cannabis

Another line of investigation will address the treatment of depression using oil rich in cannabidiol (CBD). Scheduled for April, this branch of the clinical trials with cannabis will follow a randomized methodology, monitoring patients for three months. According to the researcher, the goal is to scientifically validate reports that already suggest benefits in controlling symptoms.

The university will also expand its geographical reach with a study in the interior of Paraíba. The focus will be the topical application of a plant-based cream for wound healing in diabetics. This initiative stems from promising results obtained in a pilot study conducted in Tubarão (SC).

"We have good theoretical indications and we will test them in practice. The question is to verify what happens in more complex wounds, such as those from diabetes, which have difficulty healing," questions the coordinator about the hypothesis of the test.

In addition to studies with humans, the laboratory maintains preclinical research with animal models. Among the new developments is the investigation of tetrahydrocannabivarin (THCV) for obesity, evaluating parameters such as weight gain and neuroinflammatory markers.

The scenario of clinical trials with cannabis in Brazil

To enable high-cost projects without robust funding, the laboratory relies on strategic partnerships to maintain clinical trials with cannabis. Associations such as Santa Cannabis and Cannabis Without Borders provide supplies and ensure treatment, while researchers dedicate hours of volunteer work.

"The ideal would be to have funding and scholarships. Since we do not have this funding available, we have learned to work with what we have. There is a whole mobilization of people donating their time to make the study feasible," concludes the professor.

Regulation and the future of clinical trials with cannabis

With more than two decades dedicated to the study of cannabinoids, Bitencourt assesses the current national scenario with cautious optimism. For him, although scientific and regulatory evolution is visible, the process still occurs slowly.

"It is undeniable that we are making progress. But it is at a snail's pace, without will and, at times, very sluggishly," analyzes the researcher about the pace of advancements impacting clinical trials with cannabis.

A critical point raised is the exclusion of patient associations from formal discussions with health agencies. According to him, these entities perform an assistance work that has already been established as fundamental in the country and cannot be ignored.

Despite the criticisms, the professor acknowledges that the research environment has improved compared to the early 2000s. "Twenty years ago, we imported CBD illegally and no one knew the substance. Now the process has become easier and research is advancing. I see all of this with optimism," he concludes.