Researchers at University of Illinois at Chicago and Northwestern Medicine conducted the Pharmacotherapy of Apnea by Cannabimmimetic Enhancement (PACE), a phase II multisite, fully blinded, parallel groups randomized placebo-controlled clinical trial of Dronabinol in participants with moderate to severe obstructive sleep apnea (OSA). Dronabinol is a nonselective CB1 and CB2 receptor agonist and previously has shown promise for OSA pharmacotherapy in a small pilot study.
The PACE study participants included 73 adults between the ages of 21 and 65 years with moderate or severe OSA. Participants were randomized into one of three treatment groups: Placebo, 2.5 mg/Day Dronabinol, and 10 mg/day Dronabinol. Participants would self-administer one capsule by mouth 60 minutes before bedtime for a 6-week (42 days) treatment period. At baseline, overall apnea–hypopnea index (AHI) was 25.9 ± 11.3, Epworth Sleepiness Scale (ESS) score was 11.45 ± 3.8, maintenance of wakefulness test (MWT) mean latency was 19.2 ± 11.8 minutes, body mass index was 33.4 ± 5.4 kg/m2, and age was 53.6 ± 9.0 years.
Results showed that in comparison to placebo, participants taking 2.5 mg/day Dronabinol reduced AHI by 10.7 ± 4.4 (p = .02). Participants taking 10 mg/day Dronabinol reduced AH 12.9 ± 4.3 (p = .003) events/hour compared to placebo. Self-reported daytime sleepiness was assessed by the Epworth Sleepiness Scale (ESS). Compared to baseline, participants receiving Placebo and Dronabinol 2.5 mg/day showed no change in ESS score, however participants receiving 10 mg/day Dronabinol showed a significant decrease (-3.8 ± 0.8 points) in sleepiness compared to baseline (p < 0.0001). 88% of participants experienced one of more adverse event (AE) during participation, but the likelihood of reporting one or more AE did not differ between treatment group. Common AEs reported included sleepiness/drowsiness (n=25), headache (n=24), nausea/vomiting (n=23), and dizziness/lightheadedness (n=12).
Carley DW, Prasad B, Reid KJ, et al. Pharmacotherapy of Apnea by Cannabimimetic Enhancement, the PACE Clinical Trial: Effects of Dronabinol in Obstructive Sleep Apnea. Sleep. 2017; ePub ahead of print. Abstract
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