Targeted Treatment of Obstructive Sleep Apnea With Dronabinol: Proof of Concept and Phase II Clinical Trial

PULM-011-23F

This is an open-label trial that tests the effectiveness of Dronabinol in treating obstructive sleep apnea (OSA). All participants will take oral Dronabinol for two weeks. Sleep studies will be conducted before and after treatment to measure OSA severity.

2024-10-01

2026-09-30

2026-12-31

Not yet recruiting

Early phase I

120

Inclusion Criteria: 1. Adults 18 to 65 years of age. 2. AHI 15-50 per hour on pre-treatment polysomnography. Exclusion Criteria: 1. 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. 2. 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. 3. History of upper airway surgery for OSA (except adenotonsillectomy). 4. Central or mixed apneas \>25% of respiratory events on diagnostic polysomnography. 5. Arterial oxygen saturation \< 75% for \> 5% sleep time on pretreatment polysomnography. 6. Body mass index \> 45 kg/m2. 7. 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. 8. Active enrollment in a weight loss program. 9. Shiftwork within 3 months of enrollment. 10. High-risk occupation: commercial driver and pilot. 11. Motor vehicle accident or near-miss incident within 1 year of enrollment. 12. Current drug or habitual alcohol use or positive urine drug screen. 13. Comorbid medical and psychiatric disorders: 1. Primary sleep disorders: e.g., narcolepsy, restless legs syndrome. 2. Uncontrolled mood disorder or a diagnosis of schizophrenia. 3. Initiation of new antidepressant or antipsychotic medication within 3 months. 4. Identified as high-risk for suicide in electronic health records. 5. 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). 14. Use of sedative-hypnotic medications within 30 days of enrollment. 15. Complete blood count or liver function test values more than 1.5 times the upper limit of normal. 16. Pregnancy. 17. Allergy to cannabinoids or sesame oil. 18. Average weekly alcohol consumption of more than 10 servings. 19. Participation in other investigational protocols within 30 days of enrollment.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': '120 Veterans will be screened and enrolled to achieve 45 participants completing the study. All participants will receive oral Dronabinol treatment nightly for two weeks.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 120, 'type': 'ESTIMATED'}}

2024-06-27