Actively Recruiting

Phase 1
Phase 2
Age: 0 - 65Years
All Genders
NCT06477952

DRonabinol Treatment of OSA

Led by VA Office of Research and Development · Updated on 2025-09-12

120

Participants Needed

1

Research Sites

70 weeks

Total Duration

On this page

Sponsors

V

VA Office of Research and Development

Lead Sponsor

U

University of Illinois at Chicago

Collaborating Sponsor

AI-Summary

What this Trial Is About

This is an open-label trial that tests the effectiveness of Dronabinol in treating obstructive sleep apnea (OSA). All participants will take oral Dronabinol for two weeks. Sleep studies will be conducted before and after treatment to measure OSA severity.

CONDITIONS

Official Title

DRonabinol Treatment of OSA

Who Can Participate

Age: 0 - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults 18 to 65 years of age.
  • Apnea hypopnea index (AHI) between 15 and 50 per hour on pre-treatment sleep study.
Not Eligible

You will not qualify if you...

  • Use of positive airway pressure (PAP) treatment more than 4 hours per day for 30% of days within 3 months before enrollment.
  • Use of hypoglossal nerve stimulator (HNS) or oral appliance device more than 4 hours per day for 30% of days within 3 months before enrollment.
  • History of upper airway surgery for OSA except adenotonsillectomy.
  • Central or mixed apneas greater than 25% of respiratory events on diagnostic sleep study.
  • Arterial oxygen saturation below 75% for more than 5% of sleep time on pre-treatment sleep study.
  • Body mass index over 45 kg/m2.
  • For post-bariatric surgery patients, weight must be stable within ±15% for at least 6 months before first dose.
  • Active enrollment in a weight loss program.
  • Shift work within 3 months before enrollment.
  • High-risk occupation such as commercial driver or pilot.
  • Motor vehicle accident or near-miss incident within 1 year before enrollment.
  • Current drug or habitual alcohol use or positive urine drug screen.
  • Certain medical and psychiatric disorders including primary sleep disorders, uncontrolled mood disorder or schizophrenia, new antidepressant or antipsychotic medication within 3 months, high risk for suicide, uncontrolled medical conditions such as heart disease, arrhythmia, heart failure, COPD, respiratory failure, recent stroke, liver or kidney disease, autoimmune disorders.
  • Use of sedative-hypnotic medications within 30 days before enrollment.
  • Abnormal blood count or liver function tests more than 1.5 times the upper limit of normal.
  • Pregnancy.
  • Allergy to cannabinoids or sesame oil.
  • Average weekly alcohol consumption over 10 servings.
  • Participation in other investigational studies within 30 days before enrollment.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Jesse Brown VA Medical Center, Chicago, IL

Chicago, Illinois, United States, 60612

Actively Recruiting

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Research Team

B

Bharati Prasad, MD

CONTACT

K

Karen M Lenehan

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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