safety and efficacy study of dronabinol to treat obstructive sleep apnea

Conditions: Sleep Apnea, Obstructive

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).


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 \ 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.