Obstructive Sleep Apnea study: Dronabinol
Official title DRonabinol Treatment of OSA
ClinicalTrials.gov ID: NCT06477952
What this study is testing
What is Dronabinol?
An investigational oral medication being studied for the treatment of 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
- The study wants to see if Dronabinol can reduce the severity of OSA. Sleep studies will be done before and after treatment to measure changes.
- Who it's for
- Adults who have been diagnosed with obstructive sleep apnea.
- What's involved
- Participants will take oral Dronabinol for two weeks and have sleep studies before and after the treatment period.
- Time commitment
- The study lasts two weeks, with sleep studies at the start and end of that period.
- 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
- 1\. AHI 15-50 per hour on pre-treatment polysomnography
You likely can't join if
- Positive Airway Pressure (PAP) treatment of obstructive sleep apnea (OSA): use \> 4 hours per day for 30% of days within 3 months of enrollment.
- Hypoglossal nerve stimulator (HNS) or oral appliance device treatment with use \> 4 hours per day for 30% of days within 3 months of enrollment.
- 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 kilograms per square meter (kg/m2)
See the full eligibility criteria
- 1\. AHI 15-50 per hour on pre-treatment polysomnography
- Positive Airway Pressure (PAP) treatment of obstructive sleep apnea (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.
- 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 kilograms per square meter (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
- 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 is enrolling
- Chicago, Illinois, United States
Compensation & support
This study's listing mentions compensation or reimbursement.
No amount is published here because ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
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, so 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, but 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?
This study is enrolling now at Chicago, Illinois, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.