Study Summary: Full-spectrum CBD-rich Treatment for Anxiety

A peer-reviewed study published in November 2022 entitled "Clinical and Cognitive Improvement Following Full-spectrum, High-cannabidiol Treatment for Anxiety: Open-label Data from a Two-stage, Phase 2 Clinical Trial" that was published in the journal Communications Medicine investigated the potential ability of the hemp-derived cannabinoid cannabidiol (CBD) to effectively treat anxiety.

"Approximately 34 percent of adults in the U.S. are diagnosed with an anxiety disorder at some point in their lifetime," reported the study. It explained that a number of "conventional pharmacotherapeutic agents" are available to treat anxiety disorders, with positive outcomes experienced by many patients.


However, the study noted some negative outcomes resulting from many conventional anxiety treatments, including delayed symptom relief (of up to 12 weeks) and "bothersome side effects" that include cognitive and sexual dysfunction. Most significant, many mainstream treatment options "do not guarantee adequate symptom alleviation" and many patients do not go into remission, noted the scientists.


"Negative outcomes resulting from conventional anxiety treatments include delayed symptom relief (of up to 12 weeks) and side effects that include cognitive and sexual dysfunction."

The research reported that previous studies of animals has demonstrated "the anxiolytic [anti-anxiety] effects of CBD, a primary non-intoxicating constituent of cannabis," but that "relatively few human studies have investigated the anxiolytic effects of CBD."


The Study

The design of this research study was that of a clinical trial involving 14 subjects (11 females and three males) featuring an average age of 41, all of whom suffered from moderate to severe anxiety. Participants were recruited from "the New England area through online advertisements and social media postings."

Image courtesy Leafwize Naturals


Enrollment for the four-week trial was performed at McLean Hospital in Belmont, Massachusetts from June 2018 to February 2020. The study included a baseline visit with weekly check-ins, for a total of five visits. Participants were given about 35 mg/day of CBD and 0.80 mg/day of tetrahydrocannabinol (THC).


Patients were given a "full-spectrum, CBD-rich base extract from cannabis provided by the National Institute on Drug Abuse" that contained "9.97 mg/mL CBD (1.04 percent) and 0.23 mg/mL THC (0.02 percent)," data that was confirmed by an independent and certified testing laboratory based in Massachusetts.


"The study drug was well-tolerated, with no reported intoxication or serious adverse events," reported the scientists.

"To minimize effects of previous cannabinoid exposure, patients were required to be either cannabis naïve (<15 lifetime uses) or abstinent from regular use (defined as >1x/month) for ≥1 year prior to their baseline visit," noted the study's authors.


"The study drug was well-tolerated, with no reported intoxication, serious adverse events, or major protocol deviations," reported the scientists. Minor side effects noted included "sleepiness/fatigue, increased energy, and dry mouth," as well as acid reflux. No side effects were rated as severe, with almost all rated as mild or moderate.


Results

At the end of the four-week trial, "significant decreases were noted on all primary outcome assessments of anxiety relative to baseline on self-report measures," reported the study. It determined that the data it collected represent "evidence that four weeks of treatment with a full-spectrum, CBD-rich sublingual product is efficacious in patients with moderate-to-severe anxiety."


Assessments of mood, sleep, and quality of life "demonstrated significant improvement following four weeks of [cannabis] treatment."

At the beginning of the study, participants reported average anxiety ratings that were moderate to severe. At the end of the study, average anxiety scores fell to the "minimal or mild-to-none range of severity." Most participants achieved this level of improvement after only one week, while some required three weeks. "This rapid response...is a marked improvement over the typical time course (up to 12 weeks) often required for full treatment response using conventional pharmacotherapy," observed the researchers.


"Definite Improvement" from CBD

Participants reported that they perceived "a definite improvement that has made a real and worthwhile difference." Assessments of mood, sleep, and quality of life "demonstrated significant improvement following four weeks of [cannabis] treatment." This included a reduction of certain negative symptoms, including depression, negative mood, and sleep disturbance, with participants reporting a general "increased quality of life."


Anxiety patients also demonstrated "significantly improved performance on secondary outcome assessments of cognition," indicating that benefits were experienced outside of mood.

Most CBD is derived from hemp plants


Conclusions

The study's authors concluded their results demonstrate "significant improvement of primary outcome assessments of anxiety, providing preliminary evidence that a full-spectrum, CBD-rich product may be efficacious for treating anxiety with few side effects." They reiterated that most study participants achieved improvement after only one week, versus the typical 10-12 week improvement timeline associated with conventional pharmaceutical drugs.


"The scientists concluded that their investigation provided evidence that a full-spectrum, CBD-rich product may be efficacious for treating anxiety with few side effects."

The scientists also stressed that their study found such improvement "at a much lower dosage than a previous clinical trial using a single extracted CBD isolate product," providing additional insight into the different outcomes associated with both isolate and full-spectrum products.


Their data demonstrated "improvements on measures of mood, sleep disturbance, quality of life, and executive functioning following treatment" with full-spectrum, CBD-rich product for four weeks. This study is a precursor to a forthcoming double-blind, placebo-controlled study designed to gather additional data.


View the original study.


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