A formulation of THC and CBD significantly reduced agitation among patients with end-stage dementia in a first-of-its-kind clinical trial, MedicalXpress reports.

The multicenter, randomized, double-blind, placebo-controlled Phase II study (known as the LiBBY trial, for the recent benefits of cannabidiol and tetrahydrocannabinol) included 120 hospice-eligible participants with Alzheimer’s disease or other types of dementia they were experiencing. The findings were presented July 14 at the Alzheimer’s Association International Conference in London by researchers from the Medical University of South Carolina and Georgetown University.

Participants received either a placebo or a fast-acting oil suspension containing isolated THC and CBD. After two weeks, patients in the THC/CBD group showed a significantly greater reduction in mean agitation scores than the placebo group. The researchers said the improvement was maintained at 12 weeks.

A secondary analysis also found that 83.9% of patients in the THC/CBD group were rated as significantly less anxious after two weeks, compared to 30.5% in the placebo group. At 12 weeks, 87.2% of treatment group participants showed improvement, compared to 23.6% of placebo participants.

“Rarely do we see close to 90% of patients in a trial who respond positively to a new drug,” said Jacobo Mintzer, MD, of the Medical University of South Carolina and co-investigator of the study.

While the findings are promising, the researchers also noted that the treatment was a precisely formulated medical product administered under clinical supervision and may differ significantly from commercially available cannabis products.

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According to survey data published in Journal of Cannabis Research.

The anonymous, web-based survey involved 879 health care professionals, most of whom reported that they had already encountered cannabis use among their patients. Eighty-nine percent of respondents said they had patients who use cannabis, while 87% said they believe cannabis has therapeutic promise. Ninety-five percent said they support the legal use of medical cannabis, and 74% said they would be open to recommending medical cannabis to patients.

The survey group included mental health professionals, registered nurses, physicians, and advanced practice providers. Respondents rated their knowledge of cannabis higher for its risks and therapeutic indications, but the researchers found much lower scores when participants were tested on objective knowledge of cannabis-related risks, therapeutic uses, and mechanisms of action.

The most common sources of knowledge about cannabis were personal experience and popular media, cited by 76% and 73% of respondents, respectively. The researchers also found that fewer respondents had received structured clinical training on cannabis, although many expressed openness to using it in practice.

The most cited concerns about the clinical use of cannabis included a lack of trained providers, potential exploitation of patients, recreational misuse, and the risk of psychosis. Greater openness to the clinical use of cannabis was associated with higher knowledge of self-esteem, younger age, professional role, and less worry.

The study authors said the findings indicate a need for structured training on cannabis pharmacology, dosing, contraindications, and legal and ethical considerations, as well as better systems for monitoring the use of cannabis in patient care.

NORML Deputy Director Paul Armentano said the findings reflect the growing acceptance of medical cannabis among healthcare providers.

“The use and efficacy of medical cannabis is now widely accepted by health care professionals,” said Armentano. in a statement. “As more doctors, nurses and others integrate medical cannabis into their clinical practices, it is vital that medical associations, institutions and educational curricula alike include and embrace cannabis as a mainstream and established therapeutic option for patients.”

discovery are consistent with a 2021 study published in Cannabis and cannabinoid researchwhich found that nearly 69% of more than 2,200 US clinicians believed that cannabis has medical benefits. In that survey, 27% of respondents said they had prescribed cannabis to a patient, while 60% incorrectly identified their state’s cannabis legalization policy.

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The US Food and Drug Administration (FDA) last month granted Breakthrough Therapy designation to VER-01, a full-spectrum cannabis-derived drug for chronic low back pain made by the German company Vertanical. The designation follows two randomized, controlled Phase 3 trials, which demonstrated significant pain reduction, a favorable tolerability profile, and no evidence of addiction.

In a Phase 3 head-to-head comparison study, the drug also showed superior pain reduction and better gastrointestinal tolerability than opioids.

In a statement, Dr. Clemens Fischer, CEO of FUTRUE Group and founder of Vertanical, said that FDA designation “is a great recognition of its potential to address the significant unmet need in chronic pain.”

“Patients have waited too long for meaningful progress. We believe VER-01 has the potential to change the way chronic pain is treated and provide physicians with a much-needed non-opioid solution.” — Fischer in a press release

Phase 3 results were published last September in the journal Nature Medicine. The trial showed that the drug “provides meaningful pain reduction compared to placebo, accompanied by significant improvements in physical function and sleep quality” and that extended treatment “was associated with further reductions in pain intensity as well as sustained improvements in physical function, sleep quality, and health-related quality of life.”

The company expects marketing authorization in the first European countries in the coming weeks, but has also initiated an additional Phase 3 trial in the US to support a future FDA submission.

The FDA designation, authorized on May 18, came just weeks after the federal government displaced medical cannabis from Schedule I to Schedule III under the Controlled Substances Act.