New industry-backed research into the potential anti-anxiety effects of cannabidiol found that an oral CBD solution effectively treated mild to moderate anxiety, as well as associated depression and poor sleep quality, with no serious adverse events observed.
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“Our findings indicate that administering 300-600 mg of nanodispersible CBD oral solution for 12 weeks is effective in treating mild to moderate anxiety disorders and associated depression and sleep quality disturbances,” authors wrote. “These findings align with the growing body of evidence indicating that CBD may have anxiolytic effects if administered for a longer duration, ranging from 4 to 12 weeks.”
The report, published this month in the Asian Journal of Psychiatry, was penned by a seven-person research team from Asha Hospital and Leiutis Pharmaceuticals LLP, both in India, and New Jersey-based Biophore Pharma Inc. All authors, the paper says, participated “as employees of or consultants to Leiutis Pharmaceuticals,” which funded the study.
Use of the CBD solution “showed therapeutic efficacy, excellent safety, and tolerability in treating not only mild to moderate anxiety disorders (primary end point of the study), but also associated depression and disturbances in sleep quality (Secondary endpoint of the study)” the paper says, “with no incidences of withdrawal anxiety upon dose tapering at the end of the treatment.”
“CBD oral solution was effective treating mild to moderate anxiety.”
“Our research supports the importance of investigating the potential effectiveness of nanodispersible CBD oral solution in treating other forms of psychiatry disorders,” authors wrote, “and exploring its possible applications in clinical practice.”
Participants in the study were split into either a CBD or control group. Those in the CBD group received 300 milligrams of CBD per day at first, which increased over time to 600 mg per day and was later reduced to 150 mg per day toward the end of the study period. Those in the control group received a placebo.
A test of generalized anxiety disorder, GAD-7, found drops in anxiety markers among participants who took CBD compared to the placebo group. Mean scores “gradually decreased in the CBD group from week 2 (visit 4), which continued till week 13,” the study says, noting that the “mean GAD-7 score for CBD arm at baseline was 11.8±1.52 and the score at the end of treatment (visit-9) was 4.8±1.60, at visit-10 (dose taper) was 3.7±1.27, and at end of study (visit-11) was 3.1±1.06.”
Among those who took the placebo, the mean anxiety scores hardly changed. “The mean GAD-7 score (SD) for placebo arm at baseline (visit-3) was 11.2±1.43 and the score at end of treatment (visit-9) was 11.8±1.73, at Visit-10 (dose taper) was 11.8±1.72, and end of study (visit-11) was 11.8±1.75,” according to the report.
Another test, the Hamilton Anxiety Rating Scale (HAM-A), found similar drops in anxiety measures in CBD participants compared to the placebo group.
“CBD was therapeutically safe with no serious adverse events, well tolerated, and effective for the treatment of mild to moderate anxiety disorders, as well as associated depression and sleep quality disturbances.”
“The mean HAM-A score for CBD arm at baseline (visit-3) was 18.9±2.62 and the score at end of treatment (visit-9) was 7.34±1.77, at visit-10 (dose taper) was 5.83±1.67, and at end of study (visit-11) was 4.57±1.39,” the study says, while “the mean HAM-A score (SD) for placebo arm at baseline was 18.2±2.75 and the score at end of treatment was 18.9±2.75, at Visit-10 (dose taper) was 19.0±2.84, and end of study (visit-11) was 18.9±2.95.”
Participants in the CBD group also had their dosages reduced near the end of the study period, and no immediate increase in their anxiety was observed.
“At Visit 10 (Week 12), the drug was tapered to 150 mg/day,” the report describes, “and at the end of the study, at Visit 11 (Week 13), there was no increase in anxiety scores.”
Separate research published earlier this year found that a component of marijuana, the terpene D-limonene, may help ease anxiety and paranoia associated with the psychoactive cannabinoid THC. That study found that subjects who vaporized limonene along with a dose of THC experienced less anxiety and paranoia compared to those who consumed THC alone.
Another substance, similar to the psychedelic LSD, was also recently awarded breakthrough therapy status by the Food and Drug Administration (FDA) for the treatment of generalized anxiety disorder. The drugmaker behind the substance, known as MM120, said at the time that it plans to hold an end-of-Phase 2 meeting with FDA in the first half of 2024 and begin a Phase 3 clinical trial in the second half of the year.
According to a media representative the drugmaker, MindMed, MM120 is “a tartrate salt form of lysergide, a synthetic drug commonly known as LSD.”
The breakthrough designation is the latest in a series of developments around psychedelic-based therapies. Late last year, FDA granted priority status to its review of MDMA-assisted therapy as a potential treatment option for post-traumatic stress disorder (PTSD). The agency has set a target date to make a determination by August 11, according to applicant Lykos Therapeutics (formerly named MAPS Public Benefit Corporation).
If the new drug application is ultimately approved, the Drug Enforcement Administration (DEA) would then need to reschedule MDMA accordingly. It would become the first psychedelic in history to be approved as a pharmaceutical, to be administered in tandem with talk therapy and other supportive services.
As for CBD and anxiety, a separate study earlier this year found that dogs receiving daily doses of CBD saw “significant reductions” in stress and anxiety related to car travel.
All 20 dogs involved in that study, published in the Journal of Animal Science, exhibited signs of stress and anxiety when riding in a car, but canines treated with CBD two hours before taking the trip showed meaningful improvements over a 24-week review period.
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