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NCT Number: NCT07570953

A Study Of Synthetic THC And Sleep

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.

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Treatment and study plan

Dronabinol

Drug

10 mg dose of Dronabinol daily for 6 weeks

Placebo

Drug

10 mg dose of Placebo daily for 6 weeks

Primary outcomes

  1. Number of times subjects complete CPAP therapy

    Time frame: Baseline

    CPAP therapy is defined as using the therapeutic device for ≥ 4 hours per night

  2. Apnea-hypopnea index (AHI)

    Time frame: Day 15, Day 29, and Day 42

    Apnea-hypopnea index (AHI) an index used to describe the number of apneas experienced during sleep. It is calculated by (Number of hours of sleep/Number of Apneas or hypopneas). This value will then be graded on a scale from Normal (<5) to Severe (>30).

  3. International Physical Activity Questionnaire

    Time frame: Baseline and Day 42

    International Physical Activity Questionnaire is a 0-10 visual analog scale to assess self-reported sleep quality

Secondary outcomes

  1. 24-hour blood pressure

    Time frame: Baseline and Day 42

    Blood pressure will be monitored for 24 hours and reported as mm/Hg

  2. Blood Pressure

    Time frame: Baseline, Day 22, and Day 42

    Blood Pressure will be reported as mm/Hg

Study contacts

Contact information is provided by the study sponsor or research team.

Chieko Allgauer

CONTACT

[email protected]

507-422-3499

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
May 6, 2026
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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