Humacology has reported encouraging results from two observational trials into medicinal cannabis therapies, with the company saying the early signals justified progression to clinical trials.
The first study explored the use of broad-spectrum CBD formulations in women experiencing perimenopause and menopause, particularly those reporting anxiety and insomnia.
Co-founder James Dale said the project was driven by a lack of options beyond hormone replacement therapy (HRT).
“Women’s health is massively underserved, and other than hormone replacement therapy, there’s no real way of managing it,” Dale said.
Dale noted that in markets such as Japan, menopause is the leading reason patients turn to CBD, highlighting the global scale of unmet demand.
The study – which tracked 20 participants over six months – avoided THC due to driving concerns. Instead, patients received broad-spectrum oils containing high levels of CBD alongside CBG, CBN and CBC, typically taken two to three times a day.
CBD intake ranged from around 500mg to just over 1,000mg daily, titrated to patient response.
All participants reported improvements in their menopausal symptoms, with almost two-thirds improving to a point where their symptoms were no longer considered intrusive enough to require hormone therapy.
Those with moderate-to-severe anxiety showed clinically significant reductions, while more than 80% of participants with moderate-to-severe insomnia improved to levels no longer considered clinically significant.
A quarter of the cohort went from severe insomnia to no clinically significant insomnia, and participants reported minimal to no side effects.
General manager Joe Corcoran, who helped oversee the work, said the outcomes were comparable to those expected from HRT at the 12 to 16-week mark.
“We wouldn’t have made this amount of noise if we didn’t get these outcomes,” he said.
“I genuinely didn’t think that a broad-spectrum medicine with absolutely no THC was going to give us the same outcomes as what the national menopause society is telling us you get from HRT at 12–16 weeks.”
Corcoran said outcomes were strongest when the daily CBD amount was split into three doses taken roughly every eight hours.
“There’s a traditional mindset that 12-hourly dosing of CBD is enough,” he said.
“My experience, and what this study confirmed, is that spreading the same total amount over three doses gives unquestionable improvements.
“After eight hours you’re just chasing your tail. Patients on 12-hour dosing weren’t getting the improvements we saw with three-times-daily schedules.
“That second dose in the middle of the day blunted the stress-hormone rise and, counter-intuitively, it had the biggest impact on sleep that night.”
Humacology also conducted an observational study on patients with post-traumatic stress disorder (PTSD), with 12 participants completing the six-month program.
The cohort was treated with CBD-dominant oils at similar strengths to the menopause study, combined with micro-dosed THC of around 1–2mg per day.
“Low-dose THC has a very important role on the amygdala, creating that sense of calm and helping reduce the auditory and visual stimulus that causes stress within PTSD,” Corcoran said.
More than half of those who completed the trial demonstrated clinically meaningful improvement, with a majority falling below the threshold for significant PTSD symptoms.
“These patients are looking for alternatives to SSRIs. They’ve had enough of the fogginess and the haze. With high-quality CBD plus terpenes, and micro-dosed THC, we’re seeing outcomes that are game-changing,” Corcoran said.
Corcoran said the studies reinforced the importance of terpenes and minor cannabinoids in CBD formulations, arguing their contribution could reduce reliance on THC in some cases.
“By pairing high-strength CBD with cannabinoids such as CBN and CBG and complex terpene blends, we saw outcomes approaching what many clinicians would normally expect only from traditional full-spectrum medicines containing THC,” he said.
Dale said the women’s health results in particular had positioned Humacology to take the next step, with plans to move into a clinical trial.
“We are in discussions with several universities and expect to confirm a partner soon,” he said.