Four in 10 patients who regularly consumed benzodiazepines stopped taking the medication within about six months of initiating and being monitored on medical cannabis, Aleafia Health Inc. reports in what it believes is the first study of its kind published in peer-reviewed journal.

Appearing in Cannabis and Cannabinoid Research, the observational study featured a cohort of 146 patients receiving physician-led treatment at Canabo Medical Clinic, which is wholly owned by Aleafia, a federally licensed producer and vendor of cannabis that operates medical clinics, cannabis cultivation and research and development facilities.

With an average age of 47 years, 61 percent of patients were female, 54 percent reported prior use of cannabis and all were referred to the clinics by practising physicians outside the clinic network. “A retrospective analysis was performed on a cohort of patients using medical cannabis. These data are part of an ongoing database gathered by Canabo Medical Clinic on medical cannabis patients,” the study notes.

Benzodiapines, a class of psychoactive drugs, include the most common sedatives and anti-anxiety medications. This class of medication is used to treat anxiety, insomnia and alcohol, seizure and spasticity disorders. “Complications of long-term use include lack of concentration, dependence, tolerance, overdose and addiction,” the research adds.

Findings indicate that after completing an average two-month prescription course of medical cannabis, 30.1 percent of patients had discontinued use of benzodiazepines, 44.5 percent at follow-up after two prescriptions, and 45.2 percent at final follow-up after three medical cannabis prescription courses. This shows “a stable cessation rate over an average of six months,” study authors suggest.

Conditions precipitating cannabis treatment

Reported primary conditions driving cannabinoid treatment were grouped into neurological, 7.5 percent; pain, 47.9 percent; psychiatric conditions, 31.9 percent; and other, 12.7 percent. “After three clinic visits, 45.0 percent of patients using benzodiazepines, and 30.3 percent of patients who discontinued benzodiazepines, reported that their life was impacted by their medical condition ‘all the time’,” the research reports.

“This study found no significant difference in the proportions of CBD and THC in the cannabis used by patients who continued and those who discontinued benzodiazepines,” the study goes on to say.

Beyond a decrease in the use of benzodiazepines, “these patients, following prescription cannabis use, also reported decreased daily distress due to medical conditions,” notes a press release from Aleafia.

Citing information from the Canadian Centre on Substance Abuse and Addiction—which reports that 10 percent of the Canadian population takes prescription sedatives—the Aleafia statement notes that the centre found “benzodiazepines may lead to serious long-term complications, including dependence, overdose and death.”

That is consistent with findings recently published in The British Medical Journal. The study, which looked at all Ontarians who died of an opioid-related cause from Jan. 1, 2013 through Dec. 31, 2016, reported that benzodiazepines consumption significantly increased the risk of opioid overdose.

Growing interest in cannabis

“The study results are encouraging, and this work is concurrent with growing public interest in a rapidly developing Canadian cannabis market,” suggests Chad Purcell, lead author of the Aleafia study, who has a BSc with honours in pharmacology, a BSc in pharmacy and will receive an MD degree from Dalhousie University in 2019.

Other study authors include Andrew Davis, who has PhD and M.A. in economics from the University of Rochester and a BSc from Memorial University of Newfoundland; Dr. Nico Moolman, a clinical assistant professor at the University of Saskatchewan who specializes in head and neck surgery; and Dr. Mark Taylor, currently a professor and interim head of the Division of Otolaryngology-Head and Neck Surgery at Dalhousie University, who has more than 150 peer-reviewed publications to his credit.

Emphasizing the need for caution, however, Purcell notes that study results “do not suggest that cannabis should be used an alternative to conventional therapies.”

Among other factors, patients were not tested for verification of reported benzodiazepine discontinuation, as well as sample size and retrospective observational methodology used “preclude an inference of a causal relationship between cannabis and benzodiazepine use trend,” the study points out. “Without dependable safety data and evidence from randomized trials for this cohort, cannabis cannot be recommended as an alternative to benzodiazepine therapy,” it notes.

“Our purpose is inspiring others to advance current cannabis understanding as we collect stronger efficacy and safety data that will lead to responsible policy and recommended practices for use,” Purcell emphasizes.

“This study’s results will not be surprising to many patients who have transitioned from prescription painkillers and sedatives with the help of physician-led medical cannabis therapy,” suggests Dr. Michael Verbora, chief medical officer at Aleafia.

Still, hurdles need to be cleared—including regulatory challenges and stigma—to satisfy the current shortage of medical cannabis research, Dr. Verbora notes. “At Aleafia, we will continue to leverage our IP and leading cannabis data to further advance patient care through advanced treatment methods and specialized product development.”

The study notes the observations made merit “further investigation into the risks and benefits of the therapeutic use of medical cannabis and its role rating to benzodiazepines use.”

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