Conditions: Sleep Apnea, Obstructive
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 75
Healthy volunteers: no

Brief summary:
This is a proof of concept study to determine the safety and efficacy of dronabinol for the treatment of obstructive sleep apnea syndrome (OSA).

Detailed description:

Arms:
arm 1: Placebo, once per day (QD) by mouth, 60 minutes before bedtime for 6 weeks after 1-week run-in arm 2: Dronabinol, 2.5 mg QD by mouth, 60 minutes before bedtime for 6 weeks after 1-week placebo run-in arm 3: Dronabinol, 10 mg QD by mouth, 60 minutes before bedtime for 4 weeks after 1-week placebo run-in and 2-week dose escalation

Interventions: intervention 1: Dronabinol intervention 2: Placebo (for Dronabinol)
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: