A Study Of Synthetic THC And Sleep
Key facts
- Who runs it
- Mayo Clinic
- Where
- Rochester, United StatesSee the site
- Trial code
- Status
- Not yet recruiting
- Phase
- Phase 2/3
- People taking part
- 72 people, planned
- Started
- Nov 2026
- Expected to end
- Apr 2028
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Dronabinol
- Placebo
- Record updated
- 18 September 2026
Who can take part
- Age
- 21 years to 70 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 21 criteriaShow less
Who can take part
- 21 - 70 years of age
- Biological male or female
- AHI between 15 - 50 events/hour
- Current or new OSA diagnosis
- Established or new (within 1 month) CPAP therapy
Who cannot take part
- Use of certain antimicrobial, chemotherapeutic, anticoagulant, hypoglycemic, anti-inflammatory, psychotropic, and antihistamine drugs
- Prescribed CYP2C9 and/or CYP3A4 inhibitors
- Prior upper airway surgery for snoring or OSA as an adult
- Bariatric surgery within 2 years
- Diagnosed psychiatric disorders
- History of seizures
- History of substance abuse or recreational drug use or positive urine drug screen
- History of uncontrolled disease including:; Cardiovascular; Pulmonary; Gastrointestinal; Pancreatic; Hepatic; Renal; Hematological; Endocrine (including Type I Diabetes); Neurological; Urological
- History of shift work or rotating shifts within 1 month
- BMI > 35 kg/m2
- Hypotension
- Pregnant or breastfeeding
- Severe OSA that in the investigator's judgment should only begin CPAP treatment
- Significant defect in nasal patency due to anatomical abnormality or uncontrolled rhinitis
- Medically managed weight-loss program within 6 months
- Noninvasive treatment for OSA within 1 month (self-report)
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 21 and 70 years old?
Where in United States
- Mayo Clinic in RochesterRochester, United StatesContact: Nick WozniakNo longer taking part
About the trial
What the trial wants to find out
The purpose of this study is to determine if oral dronabinol prior to sleep can improve CPAP adherence and sleep quality in humans. We also seek to determine if combination therapy of CPAP and pre-sleep dronabinol is associated with improved BP regulation. We will also explore BP regulatory mechanisms and whether these are impacted differently between traditional CPAP therapy and combination CPAP/dronabinol.
The 2 groups in the trial
- DronabinolTreatment being tested
Patients assigned to the Dronabinol arm will be taking the Study drug (Dronabinol) one hour prior to bed each night for 6 weeks.
- PlaceboPlacebo, for comparison
Patients assigned to the placebo arm will be taking the placebo pill (sugar pill) one hour prior to bed each night for 6 weeks.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Effects Of Nocturnal Dronabinol Use On Obstructive Sleep Apnea Treatment And Physiological Outcomes
- Fit questions
- Built from NCT07570953, who can take part
- Record updated
- 18 September 2026