DRonabinol Treatment of OSA

Last updated: September 5, 2025
Sponsor: VA Office of Research and Development
Overall Status: Active - Recruiting

Phase

1/2

Condition

Sleep Apnea Syndromes

Treatment

Dronabinol

Clinical Study ID

NCT06477952
PULM-011-23F
  • Ages < 65
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Adults 18 to 65 years of age.

  2. AHI 15-50 per hour on pre-treatment polysomnography.

Exclusion

Exclusion Criteria:

  1. Positive Airway Pressure (PAP) treatment of OSA: use > 4 hours per day for 30% ofdays within 3 months of enrollment. PAP use will be determined from device downloaddata.

  2. Hypoglossal nerve stimulator (HNS) or oral appliance device treatment with use > 4hours per day for 30% of days within 3 months of enrollment. HNS use will bedetermined 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 pretreatmentpolysomnography.

  6. Body mass index > 45 kg/m2.

  7. If post-bariatric surgery, weight must be stable ±5% (per electronic medicalrecords) 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:

  14. Primary sleep disorders: e.g., narcolepsy, restless legs syndrome.

  15. Uncontrolled mood disorder or a diagnosis of schizophrenia.

  16. Initiation of new antidepressant or antipsychotic medication within 3 months.

  17. Identified as high-risk for suicide in electronic health records.

  18. Uncontrolled medical disorders (coronary heart disease, arrhythmia, congestiveheart failure, chronic obstructive pulmonary disease, chronic hypoxemic orhypercapnic respiratory failure, stroke within 6 months of enrollment, chronicliver or kidney disease, autoimmune disorders).

  19. Use of sedative-hypnotic medications within 30 days of enrollment.

  20. Complete blood count or liver function test values more than 1.5 times the upperlimit of normal.

  21. Pregnancy.

  22. Allergy to cannabinoids or sesame oil.

  23. Average weekly alcohol consumption of more than 10 servings.

  24. Participation in other investigational protocols within 30 days of enrollment.

Study Design

Total Participants: 120
Treatment Group(s): 1
Primary Treatment: Dronabinol
Phase: 1/2
Study Start date:
August 25, 2025
Estimated Completion Date:
December 31, 2026

Study Description

Obstructive sleep apnea (OSA), is a serious respiratory disorder that involves repetitive cessation of breathing during sleep. It is estimated that 15-20 million people in the United States suffer from OSAS, which has been linked to increased risk for hypertension, heart failure, depression, and diabetes. The current standard of care for OSA, positive airway pressure (PAP), involves a mechanical device with low patient tolerance and adherence. Upper airway surgical approaches are also an option but are invasive and often unsuccessful. Effective drug treatments for OSA remain to be identified.

This study will enroll up to 120 Veterans so that 45 Veterans may complete the two-week open-label Dronabinol treatment trials. The results of the study will be used to develop a prediction model for OSA severity reduction after 2-week Dronabinol treatment vs. pretreatment AHI. Participants clinical (age, sex, body mass index, comorbidity) and pretreatment polysomnographic characteristics (sleep architecture, respiratory disturbance, and endotypes; loop-gain, arousal threshold, upper airway collapsibility and compensation) will be used to develop a prediction model for improvement of OSA with Dronabinol treatment. This prediction model will be used for a randomized clinical trial after the completion of this trial.

Connect with a study center

  • Jesse Brown VA Medical Center, Chicago, IL

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Jesse Brown VA Medical Center, Chicago, IL

    Chicago 4887398, Illinois 4896861 60612
    United States

    Active - Recruiting

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