DRonabinol Treatment of OSA

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

DRonabinol Treatment of OSA (NCT06477952) is a Phase 1 / Phase 2 interventional studying Obstructive Sleep Apnea, sponsored by VA Office of Research and Development. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Obstructive Sleep Apnea, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 120 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Obstructive Sleep Apnea subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Adults 18 to 65 years of age. 2. AHI 15-50 per hour on pre-treatment polysomnography. Who Should NOT Join This Trial: 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

DRUG

Dronabinol

Open label Dronabinol treatment for two weeks.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Jesse Brown VA Medical Center, Chicago, IL

Chicago, Illinois, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06477952), the sponsor (VA Office of Research and Development), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06477952 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06477952?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06477952?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06477952. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06477952. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.