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New treatment option for Obstructive Sleep Apnea
Official title DRonabinol Treatment of OSA
ClinicalTrials.gov ID: NCT06477952
What this study is testing
What is Dronabinol?
Dronabinol is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for obstructive sleep apnea.
Also referred to as Marinol.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 65
You may be able to join if
- Adults 18 to 65 years of age.
- AHI 15-50 per hour on pre-treatment polysomnography.
You likely can't join if
- 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...
- 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...
- History of upper airway surgery for OSA (except adenotonsillectomy).
- Central or mixed apneas \>25% of respiratory events on diagnostic polysomnography.
- Arterial oxygen saturation \ 5% sleep time on pretreatment polysomnography.
- Body mass index \> 45 kg/m2.
See the full eligibility criteria
- Adults 18 to 65 years of age.
- AHI 15-50 per hour on pre-treatment polysomnography.
- 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...
- History of upper airway surgery for OSA (except adenotonsillectomy).
- Central or mixed apneas \>25% of respiratory events on diagnostic polysomnography.
- Arterial oxygen saturation \ 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...
- 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.
- Pregnancy.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, up to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.