NCT06477952 · VA Office of Research and Development
DRonabinol Treatment of OSA
(DROSA)
What this study is about
This is an where both patients and doctors know the treatment given trial that tests the effectiveness of Dronabinol in treating obstructive sleep apnea (OSA). All participants will take taken by mouth Dronabinol for two weeks. Sleep studies will be conducted before and after treatment to measure OSA severity.
View original scientific description
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.
Interventions
DRUG
Dronabinol
Open label Dronabinol treatment for two weeks.
Primary outcome measures
Apnea hypopnea index (AHI)
Time frame: 2 weeks
The change in AHI after two weeks of Dronabinol treatment will be determined from before and after treatment polysomnograms.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Adults 18 to 65 years of age.
- AHI 15-50 per hour on pre-treatment polysomnography.
Exclusion criteria
- 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.
- 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.
- History of upper airway surgery for OSA (except adenotonsillectomy).
- Central or mixed apneas \>25% of respiratory events on diagnostic polysomnography.
- Arterial oxygen saturation \< 75% for \> 5% sleep time on pretreatment polysomnography.
- Body mass index \> 45 kg/m2.
- 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.
- Active enrollment in a weight loss program.
- Shiftwork within 3 months of enrollment.
- High-risk occupation: commercial driver and pilot.
- Motor vehicle accident or near-miss incident within 1 year of enrollment.
- Current drug or habitual alcohol use or positive urine drug screen.
- Comorbid medical and psychiatric disorders:
- Primary sleep disorders: e.g., narcolepsy, restless legs syndrome.
- Uncontrolled mood disorder or a diagnosis of schizophrenia.
- Initiation of new antidepressant or antipsychotic medication within 3 months.
- Identified as high-risk for suicide in electronic health records.
- 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).
- Use of sedative-hypnotic medications within 30 days of enrollment.
- Complete blood count or liver function test values more than 1.5 times the upper limit of normal.
- Allergy to cannabinoids or sesame oil.
- Average weekly alcohol consumption of more than 10 servings.
- Participation in other investigational protocols within 30 days of enrollment.
Where
- Chicago, Illinois
Collaborators
University of Illinois at Chicago
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 12, 2025 · Source of record for eligibility and locations