Given decreased stigma and growing popularity of cannabis, a trend for increased use among women is beginning to emerge, narrowing the gender gap. In particular, women frequently report cannabis use for medical purposes and often aim to address women’s health-related issues specifically. The Marijuana Investigations for Neuroscientific Discovery (MIND) program at McLean Hospital is not only dedicated to examining the impact of medical cannabis use overall but, through the Women’s Health Initiative at MIND (WHIM), is also specifically exploring cannabis use for women’s health and disorders that exclusively or disproportionately affect women.

In this presentation, Dr. Gruber will share data from several of WHIM’s novel, first-of-their-kind studies, highlighting interim results from women enrolled in a proof-of-concept clinical trial of a novel, high-cannabidiol product for anxiety and mood in patients with bipolar disorder. As part of this four-week, open-label clinical trial, eligible patients complete baseline assessments of anxiety (Beck Anxiety Inventory [BAI], Hamilton Anxiety Rating Scale [HAM-A]) and mood (Beck Depression Inventory [BDI], Montgomery-Asberg Rating Scale [MADRS]). After baseline, patients self-administer the sublingual solution BID (target daily dose: 125mg CBD) and return for weekly follow-up assessments where clinical scales are completed and adverse events are documented. One-tailed paired t-tests examined changes between baseline and final study visits in completers to date (n=8). Interim analyses demonstrate notable improvements; self-report ratings indicate significant decreases on the BAI (-70.13%, p=.003) and BDI (-60.00%, p=.011), while clinician ratings reflect significant decreases on the HAM-A (-65.61%, p<.001) and MADRS (-71.88%, p<.001). Further, the study product appears to be safe and well-tolerated, as no serious adverse events have been reported.

Dr. Gruber will also discuss additional studies within WHIM, including a recently launched clinical trial for endometriosis as well as studies focused on other conditions that impact women. These innovative data represent an important step forward, as the development and implementation of alternative cannabinoid-based treatments have the potential to positively impact countless women, ultimately advancing women’s health equity.

Learning Objectives:

• Understand the scope and describe current projects underway at the Women's Health Initiative at MIND

• Identify clinical changes in patients with bipolar disorder from the very first clinical trial of a custom-formulated, broad-spectrum, high-CBD product