NCT06477952 DRonabinol Treatment of OSA
| NCT ID | NCT06477952 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | VA Office of Research and Development |
| Condition | Obstructive Sleep Apnea |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-08-25 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 120 participants in total. It began in 2025-08-25 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Bharati Prasad, MD
PRINCIPAL INVESTIGATOR
Jesse Brown VA Medical Center, Chicago, IL
Frequently Asked Questions
Who can join the NCT06477952 clinical trial?
This trial is open to participants of all sexes, up to 65 Years, studying Obstructive Sleep Apnea. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06477952 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06477952 currently recruiting?
Yes, NCT06477952 is actively recruiting participants. Contact the research team at bharati.prasad@va.gov for enrollment information.
Where is the NCT06477952 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT06477952 clinical trial?
NCT06477952 is sponsored by VA Office of Research and Development. The principal investigator is Bharati Prasad, MD at Jesse Brown VA Medical Center, Chicago, IL. The trial plans to enroll 120 participants.