Should the results of a new research effort turn out to be positive, doctors could soon be on the verge of prescribing medical cannabis as a neuropsychiatric treatment. Stretching over eight weeks, the open-label clinical trial is set to take place by a team at McLean Hospital in Belmont, Massachusetts.

This looming study on cannabis for neuropsychiatric conditions will be followed by an assessment of cannabidiol’s (CBD) efficacy in treating patients with Alzheimer’s disease (AD) and the behavioral symptoms of anxiety.

“There is no current FDA-approved treatment for these neuropsychiatric symptoms of Alzheimer’s disease, so a lot of these older folks are being prescribed off-label antipsychotics or [selective serotonin reuptake inhibitors] to treat their neuropsychiatric symptoms such as anxiety and agitation,” said one of the team’s lead researchers, Kaitlin R. McManus. “As a really vulnerable population, they are prone to side effects from these off-label treatments.”

According to the hospital’s associate professor of psychiatry, Brent P. Foster, MD, the medical facility already possesses a broad spectrum of medicines that have been repurposed from various other psychiatric conditions. However, the vast majority of these medicines are not effective and may carry the risk of death or unwanted side effects.

Cannabis for neuropsychiatric conditions: Researchers will use industrial hemp-derived CBD/THC solution

Modifying certain risk factors can help to reduce the prevalence of dementia. With this in mind, the researchers intend on recruiting 12 participants who’ve been diagnosed with mild to moderate Alzheimer’s dementia. Additionally, the study subjects will suffer from agitated or non-agitated behavioral symptoms of anxiety.

A unique and custom-formulated sublingual solution will be administered to the Alzheimer’s patients. Developed by Staci Gruber, PhD, at McLean Hospital, the industrial hemp-derived solution will contain high levels of CBD and low traces of THC (tetrahydrocannabinol).

At the current time, a clinical trial is being carried out by Dr. Gruber’s team. Although the same CBD solution will be used for that specific trial, the target patient demographic differs in the sense that it will be focused on people who endure moderate to severe anxiety; as opposed to those who experience AD.

The key success outcome evaluations for this study on cannabis for neuropsychiatric conditions are noted as the anxiety domain of the Neuropsychiatric Inventory-Clinician version (NPI-C) and the Generalized Anxiety Disorder-7 Item Scale (GAD-7). 

Included in the list of secondary safety outcome measures are continuous monitoring for serious adverse events and medication side effects, cognitive decline calculations, and the arising of possible delirium.

Cannabis for neuropsychiatric conditions: CBD solution expected to be well-tolerated by study subjects 

Preliminary results from Dr. Gruber’s study have enabled researchers to hypothesize that “twice daily treatment with the CBD solution in older adults with AD for 8 weeks will be associated with a statistically significant reduction in anxiety symptoms compared to baseline, as measured by our efficacy outcome measurements.”

Researchers anticipate that study subjects will tolerate the solution well; according to an assessment of their safety outcome measurements. The team declared that CBD holds promise as an anxiolytic treatment, which could essentially broaden hospital treatment options for anxiety and agitation in AD.

“Treating anxiety and agitation in these patients not only alleviates their symptoms but could also reduce caregiver burden and lengthen the time to institutionalization. CBD is a promising anxiolytic treatment that could advance our available treatment options for anxiety and agitation in AD,” the team concluded.