Safety and Efficacy Study of Dronabinol to Treat Obstructive Sleep Apnea

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


Eligibility Criteria:
Inclusion Criteria:

* Adult 21 to 64 years of age;
* 15≤AHI ≤ 50 on screening polysomnogram (PSG)
* ESS score ≥ 7
* Able to understand and complete informed consent and all study assessments and forms, presented in an English-speaking format;
* Women of child-bearing potential (WCBP) must have a negative urine pregnancy test. In addition sexually active WCBP must agree to use adequate contraceptive methods (oral, injectable or implantable hormonal contraceptive; tubal ligation; intra-uterine devices; barrier contraceptive with spermicide; or vasectomized partner).

Exclusion Criteria:

* Arterial oxygen saturation \< 75% for \> 5% of sleep period time on screening PSG;
* Occupation or life situation that may impart risk by study participation (e.g. commercial driver, pilot, police officer, fireman);
* Motor vehicle accident or "near-miss" related to sleepiness (self-report) within 2 years of the first dose of study drug (Day 8);
* Body mass index \> 45 kg/m2
* Severe obstructive sleep apnea syndrome (OSAS) that, based on the clinical judgment of the Investigator, precludes delaying positive airway pressure treatment;
* History of shift work or rotating shifts within the month prior to the first dose of study drug (Day 8);
* Prior upper airway surgery for snoring or OSAS as an adult (≥ 18 years of age);
* Prior non-invasive treatment for OSAS within 6 months prior to the first dose of study drug (Day 8);
* Major surgery within 6 months prior to the first dose of study drug (Day 8);
* Bariatric surgery within 2 years prior to the first dose of study drug (Day 8). If post-bariatric surgery, weight must be stable ±5% (self-report) for at least 6 months prior to first dose of study drug (Day 8).
* Any form of medically managed weight loss program within 6 months prior to the first dose of study drug (Day 8);
* Significant defect in nasal patency due to anatomical abnormalities or uncontrolled or recurrent episodes of rhinitis;
* Any clinically significant unstable or progressive medical condition;
* Any primary sleep disorder other than OSAS as determined by history, physical examination, or Visit 2 PSG (after 7-day screening run-in period);
* Clinically significant or uncontrolled: chronic obstructive pulmonary disease (COPD), cardiovascular disease, gastrointestinal, respiratory, pancreatic, hepatic, renal, hematologic, endocrine \[including insulin-dependent diabetes mellitus (IDDM)\], neurological, urogenital, connective tissue, dermatological, thyroid, or other medical disorder;
* Any clinically significant psychiatric disorder;
* History of seizure disorder;
* Treatment with any prescription antidepressant medication within 1 month prior to the first dose of study drug (Day 8);
* Treatment with sedatives, hypnotics or other psychoactive drugs within 30 days prior to the first dose of study drug (Day 8);
* Any complete blood count (CBC) or liver function test (LFT) laboratory value outside the normal range which, in the clinical judgment of the Investigator renders a subject inappropriate for randomization to treatment;
* Pregnancy \[as demonstrated by positive urine human chorionic gonadotropin (hCG) test\] or lactation;
* Allergic to cannabinoids or sesame oil;
* History of substance abuse (including alcohol abuse or dependence) or laboratory evidence of drug abuse on the Visit 1 drug-screening panel;
* Use of dietary supplements which in the judgment of the Investigator may impact sleep or breathing behaviors;
* Average daily caffeine consumption \> 500 mg/day (\~5 cups of coffee);
* Average weekly alcohol consumption \> 10 units;
* Unwillingness to abstain from caffeine and alcohol on all days when overnight or daytime testing will be performed;
* Participation in any other investigational protocol within the 30 days prior to the first dose of study drug (Day 8);
* Any condition which, in the opinion of the Investigator, places the patient at unacceptable risk if he or she were to participate in the study.