Wearable-Derived Physical Activity and Sleep Outcomes Following Sub-Lingual Administration of Cannabidiol for Knee OsteoArthritis (SLACK-OA): A Randomized Placebo-Controlled Crossover Trial

John Stauffer, MS
University of Florida

Co-authors: John W. Stauffer¹, Jenessa L. Bailey¹, Paul A. Borsa^1
1University of Florida

Background: Cannabidiol (CBD) is a heavily marketable product for pain management, sleep-optimization and overall recovery. Despite increased consumer use, evidence supporting objective measurements within sleep and physical activity (PA) remain limited. Wearable technology offers an opportunity to continuously monitor these physiological behaviors in ecologically valid conditions providing insight past patient reported outcomes (PROs).

Objective(s): Adults with diagnosed symptomatic knee osteoarthritis (KOA) aged 40-75 years participated in a randomized, double-blind placebo-controlled crossover trial. Across two 30-day observation periods, participants were provided with both CBD (150mg/d) and placebo (0mg/d) separated by a 14-day washout period to avoid potential carryover effect. By utilizing the Ametris® LEAP, an FDA approved medical-grade device, PA and sleep metrics were able to be continuously monitored. PA outcomes included daily step count, total moderate-to-vigorous physical activity (MVPA) and specific time allocated in each light, moderate, vigorous, and very vigorous activity. Sleep outcomes included total sleep time (TST), minutes in bed, wake after sleep onset (WASO), number of awakenings, average awakening length, movement index, fragmentation index, sleep fragmentation index, and overall sleep efficiency. All participant-level median values for these metrics were evaluated and compared with paired Wilcoxon signed-rank tests.

Results: Across these metrics there were no statistically significant differences between CBD and placebo as all values recorded p-values > 0.05. Despite non-significance, trends favoring CBD across sleep outcomes including TST (286.0 vs. 270.0 minutes; p = 0.109), total minutes in bed (289.5 vs 283.0 minutes; p = 0.068) were observed. MVPA similar to sleep had reported non-significant trends as both vigorous and very vigorous activity demonstrated trends in favor of CBD (% Vigorous: 2.754 vs 2.47; p = 0.093, % Very Vigorous: 0.23 vs 0.16; p= 0.058).

Conclusions: Sublingually administrated CBD for thirty days did not significantly alter wearable-derived physiological behavior when compared against placebo in adults diagnosed with KOA. Despite small trends favoring CBD across several sleep and PA metrics, these differences were marginal. These findings however may suggest that possible physiological effects induced by CBD in ecologically valid sleep and activity conditions are minimal due to the dosing protocol used in this study design. However, integrating wearable technology for objective evaluation in intervention efficacy for chronic pain trials has demonstrated value that can further be explored.