A Study Of Synthetic THC And Sleep

Starting soon · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Obstructive Sleep Apnea

In brief

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.

Key facts

Study ID

NCT07570953

Run by

Mayo Clinic

People needed

72

Starts

2026-09-01

Expected to finish

2028-04-01

Last updated by the study team

2026-07-16

Who can join

Age: 21 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 21 - 70 years of age
• Biological male or female
• AHI between 15 - 50 events/hour

You may not qualify if…

• BMI > 35 kg/m2
• Diagnosed psychiatric disorders
• Hypotension
• 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
• Pregnant or breastfeeding
• Use of certain antimicrobial, chemotherapeutic, anticoagulant, hypoglycemic, anti-inflammatory, psychotropic, and antihistamine drugs
• Prescribed CYP2C9 and/or CYP3A4 inhibitors
• Severe OSA that in the investigator's judgment should only begin CPAP treatment
• Prior upper airway surgery for snoring or OSA as an adult
• Significant defect in nasal patency due to anatomical abnormality or uncontrolled rhinitis
• Bariatric surgery within 2 years
• Medically managed weight-loss program within 6 months
• Noninvasive treatment for OSA within 1 month (self-report)

Where it is running

• Mayo Clinic in Rochester — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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