The endocannabinoid system is involved in gynecological functions, with cannabidiol (CBD) demonstrating promise for alleviating menstrual-related symptoms. This survey-based, quasi-experimental study assessedpro re nata(PRN) use of a commercially-available, hemp-derived, broad-spectrum, high-CBD (100 mg) vaginal suppository (Foria®) for menstrual-related pain and discomfort compared to a treatment-as-usual (TAU) group (CBDn = 77, TAUn = 230), with survey assessments collected at baseline and two monthly follow-ups (~2 menstrual cycles). The CBD group demonstrated significantly reduced frequency and severity of menstrual-related symptoms, impact of symptoms on daily functioning, need for analgesics, and number of analgesics used relative to the TAU group (ps ≤ 0.032). Correlation analyses indicated a potential dose-dependent response, with increased suppository use associated with greater reduction of symptoms (ps ≤ 0.025). Most CBD participants reported at least moderate improvement of symptoms (follow-up 1 = 72.9%, follow-up 2 = 81.1%). Future studies (including replication in randomized clinical trials) assessing pharmacokinetics/pharmacodynamics, mechanism(s) of action, efficacy for other gynecological indications, and potential adverse events (e.g., drug-drug interactions) are indicated.

Background/Objectives: Cannabidiol (CBD) is a non-intoxicating cannabinoid touted for a variety of medical benefits, including alleviation of anxiety. While legalization of hemp-derived products in the United States (containing ≤0.3% delta-9-tetrahydrocannabinol [d9-THC] by weight) has led to a rapid increase in the commercialization of hemp-derived CBD products, most therapeutic claims have not been substantiated using clinical trials. This trial aimed to assess the impact of 6 weeks of treatment with a proprietary hemp-derived, full-spectrum, high-CBD sublingual solution similar to those available in the marketplace in patients with anxiety. Methods: An open-label pilot clinical trial (NCT04286594) was conducted in 12 patients with at least moderate levels of anxiety. Patients self-administered a hemp-derived, high-CBD sublingual solution twice daily during the 6-week trial (target daily dose: 30 mg/day CBD). Clinical change over time relative to baseline was assessed for anxiety, mood, sleep, and quality of life, as well as changes in cognitive performance on measures of executive function and memory. Safety and tolerability of the study product were also evaluated. Results: Patients reported significant reductions in anxiety symptoms over time. Concurrent improvements in mood, sleep, and relevant quality of life domains were also observed, along with stable or improved performance on all neurocognitive measures. Few side effects were reported, and no serious adverse events occurred. Conclusions: These pilot findings provide initial support for the efficacy and tolerability of the hemp-derived, high-CBD product in patients with moderate-to-severe levels of anxiety. Double-blind, placebo-controlled studies are indicated to obtain robust data regarding efficacy and tolerability of these types of products for anxiety.