A Study Of Synthetic THC And Sleep

Effects Of Nocturnal Dronabinol Use On Obstructive Sleep Apnea Treatment And Physiological Outcomes

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.

Inclusion Criteria

• 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

Exclusion Criteria

• 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)

• History of shift work or rotating shifts within 1 month