A randomized, double-blind, placebo-controlled study published in SLEEP by Oxford Academic found that a combination treatment of dronabinol (IHL-42X), a synthetic form of THC, and acetazolamide, significantly reduced the severity of obstructive sleep apnea (OSA).
Conducted by researchers from The University of Western Australia, Monash University, and several Australian hospitals, the study explored the safety and efficacy of this pharmaceutical approach for patients struggling with traditional OSA treatments.
The study enrolled participants with moderate to severe OSA, defined as having an apnea-hypopnea index (AHI) of 15 or more events per hour. Eleven participants underwent one week of nightly IHL-42X at low, medium, and high doses, as well as a placebo, with a one-week washout period between treatments. The primary outcomes measured were changes in AHI, oxygen desaturation index (ODI), daytime sleepiness (Epworth Sleepiness Scale), and mood, while adverse events (AEs) were monitored throughout.
Results showed that IHL-42X significantly reduced AHI across all doses compared to the placebo. Reductions in AHI from baseline ranged from 16.4 to 19.7 events per hour for the treatment groups, while the placebo only saw a reduction of 2.8 events per hour (p<0.05 for all doses). Additionally, the medium dose of IHL-42X led to significant improvements in ODI compared to placebo, though changes in daytime sleepiness and mood were not observed.
The treatment was well-tolerated, with no serious adverse events reported. However, 35 mild to moderate AEs were associated with IHL-42X, compared to 5 during placebo use.
“One week of nightly IHL-42X at low, medium, and high doses was well tolerated, safe and associated with significant reductions in OSA severity”. concludes the study.
