Dronabinol for Obstructive Sleep Apnea
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether taking dronabinol, a medication, before bed can improve sleep quality and help people consistently use their CPAP machines, which are vital for sleep apnea treatment. Researchers are also examining how this combination might affect blood pressure and how it compares to using only a CPAP machine. The trial targets individuals with moderate sleep apnea, characterized by 15 to 50 breathing interruptions per hour during sleep. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to potentially groundbreaking treatment advancements.
Will I have to stop taking my current medications?
The trial excludes participants using certain antimicrobial, chemotherapeutic, anticoagulant, hypoglycemic, anti-inflammatory, psychotropic, and antihistamine drugs, as well as those prescribed CYP2C9 and/or CYP3A4 inhibitors. If you are taking any of these medications, you may need to stop them to participate.
Is there any evidence suggesting that dronabinol is likely to be safe for humans?
Research has shown that dronabinol is safe and generally well-tolerated by people with obstructive sleep apnea (OSA). Studies used doses ranging from 2.5 to 10 mg per day without major safety issues. Notably, patients with moderate to severe OSA in stable health did not experience serious side effects when taking dronabinol. Although the FDA has not approved dronabinol for treating OSA, its long-standing use for other conditions supports its safety. However, limited information exists on the long-term safety of dronabinol for OSA.12345
Why do researchers think this study treatment might be promising for sleep apnea?
Most treatments for obstructive sleep apnea, like CPAP machines, focus on keeping airways open during sleep. However, Dronabinol is unique because it targets the brain's control of the upper airway muscles, potentially offering a new way to manage the condition. As a synthetic form of THC, the active ingredient in cannabis, Dronabinol may help reduce the number of apneas by enhancing muscle tone, offering a promising alternative for those who struggle with traditional mechanical therapies. Researchers are excited about its potential to provide relief through a different mechanism, which could be a game-changer for patients who find existing treatments uncomfortable or ineffective.
What evidence suggests that dronabinol might be an effective treatment for obstructive sleep apnea?
Research has shown that dronabinol might help people with obstructive sleep apnea (OSA), a condition where breathing repeatedly stops and starts during sleep. Studies have found that dronabinol can reduce the apnea-hypopnea index (AHI), which measures the severity of OSA. In this trial, participants in the dronabinol group will take the study drug one hour before bed each night for 6 weeks. Patients using dronabinol reported feeling less sleepy and more satisfied with their treatment compared to those taking a placebo. These findings suggest that dronabinol could effectively treat OSA by improving breathing during sleep.23678
Who Is on the Research Team?
Virend Somers, M.D., Ph.D.
Principal Investigator
Mayo Clinic
Are You a Good Fit for This Trial?
This trial is for adults aged 21 to 70, both men and women, who have moderate to moderately severe obstructive sleep apnea (AHI between 15-50 events per hour).Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either Dronabinol or placebo one hour prior to bed each night for 6 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Dronabinol
Trial Overview
The study compares taking dronabinol (a synthetic form of THC) before sleep versus a placebo, alongside standard CPAP therapy. It looks at whether this combination improves CPAP use, sleep quality, and blood pressure control.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Patients assigned to the Dronabinol arm will be taking the Study drug (Dronabinol) one hour prior to bed each night for 6 weeks.
Patients assigned to the placebo arm will be taking the placebo pill (sugar pill) one hour prior to bed each night for 6 weeks.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor
Citations
Effects of Dronabinol in Obstructive Sleep Apnea - PMC - NIH
In comparison to placebo, dronabinol was associated with lower AHI, improved self-reported sleepiness, and greater overall treatment satisfaction. Larger scale ...
randomized dose finding study of combination dronabinol and ...
This study provides proof-of-concept data, from a small sample, that a combination of acetazolamide and dronabinol, taken over a week, reduced the AHI and is ...
NCT06477952 | DRonabinol Treatment of OSA
This is an open-label trial that tests the effectiveness of Dronabinol in treating obstructive sleep apnea (OSA).
The Impact of Acetazolamide and Dronabinol on ...
Our findings suggest that medium and high doses of Aceta-Dro primarily reduce OSA severity by lowering loop gain, while the efficacy of the low dose was due to ...
Dronabinol, acetazolamide combination lowers OSA severity
Between baseline and the 28-day mark, the release reported a significant decrease in AHI among patients receiving IHL-42X vs. placebo (P < .05).
NCT01755091 | Safety and Efficacy Study of Dronabinol to ...
This is a proof of concept study to determine the safety and efficacy of dronabinol for the treatment of obstructive sleep apnea syndrome (OSA).
Cannabinoids for obstructive sleep apnea: A systematic review
The American Academy of Sleep Medicine does not recommend using cannabinoids to treat OSA due to a lack of long-term safety and efficacy data.
Proof of concept trial of dronabinol in obstructive sleep apnea
Dronabinol treatment is safe and well-tolerated in OSA patients at doses of 2.5-10 mg daily and significantly reduces AHI in the short-term.
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