DRonabinol Treatment of OSA

Exclusion Criteria24

• Positive Airway Pressure (PAP) treatment of OSA: use > 4 hours per day for 30% of days within 3 months of enrollment. PAP use will be determined from device download data.
• Hypoglossal nerve stimulator (HNS) or oral appliance device treatment with use > 4 hours per day for 30% of days within 3 months of enrollment. HNS use will be determined by device download and oral appliance use by self-report.
• History of upper airway surgery for OSA (except adenotonsillectomy).
• Central or mixed apneas >25% of respiratory events on diagnostic polysomnography.
• Arterial oxygen saturation < 75% for > 5% sleep time on pretreatment polysomnography.
• Body mass index > 45 kg/m2.
• If post-bariatric surgery, weight must be stable ±5% (per electronic medical records) for at least 6 months before the first dose of the study drug.
• Active enrollment in a weight loss program.
• Shiftwork within 3 months of enrollment.
• High-risk occupation: commercial driver and pilot.
• Motor vehicle accident or near-miss incident within 1 year of enrollment.
• Current drug or habitual alcohol use or positive urine drug screen.
• Comorbid medical and psychiatric disorders:
• Primary sleep disorders: e.g., narcolepsy, restless legs syndrome.
• Uncontrolled mood disorder or a diagnosis of schizophrenia.
• Initiation of new antidepressant or antipsychotic medication within 3 months.
• Identified as high-risk for suicide in electronic health records.
• Uncontrolled medical disorders (coronary heart disease, arrhythmia, congestive heart failure, chronic obstructive pulmonary disease, chronic hypoxemic or hypercapnic respiratory failure, stroke within 6 months of enrollment, chronic liver or kidney disease, autoimmune disorders).
• Use of sedative-hypnotic medications within 30 days of enrollment.
• Complete blood count or liver function test values more than 1.5 times the upper limit of normal.
• Pregnancy.
• Allergy to cannabinoids or sesame oil.
• Average weekly alcohol consumption of more than 10 servings.
• Participation in other investigational protocols within 30 days of enrollment.