Safety and Efficacy Study of Dronabinol to Treat Obstructive Sleep Apnea
Condition: Sleep Apnea, Obstructive
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Intervention: Dronabinol; Placebo (for Dronabinol)
Intervention MeSH terms: Dronabinol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 75.0
Sex: All
Minimum age: 21 Years
Maximum age: 64 Years
Healthy volunteers: No

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 < 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.