DRonabinol Treatment of OSA

NCT06477952 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: PULM-011-23F
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Obstructive Sleep Apnea

Keywords

OSA; sleep apnea; pharmacological treatment; Drug treatment

Outcome Measures

Primary Outcomes (1)

• Apnea hypopnea index (AHI)

  The change in AHI after two weeks of Dronabinol treatment will be determined from before and after treatment polysomnograms.

  2 weeks

Secondary Outcomes (1)

• T<90

  2 weeks

Other Outcomes (11)

• Psychomotor Vigilance Test (PVT)

  2 weeks

• 24-hour mean arterial blood pressure (BP)

  2 weeks

• Sleep Efficiency

  2 weeks

Study Arms (1)

Single group

EXPERIMENTAL

Open label Dronabinol treatment for two weeks.

Drug: Dronabinol

Interventions

Dronabinol DRUG

Open label Dronabinol treatment for two weeks.

Also known as: Marinol

Single group

Eligibility Criteria

• Age: Up to 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults 18 to 65 years of age.
• AHI 15-50 per hour on pre-treatment polysomnography.

You may not qualify if:

• Positive Airway Pressure (PAP) treatment of OSA: use \> 4 hours per day for 30% of days within 3 months of enrollment. PAP use will be determined from device download data.
• Hypoglossal nerve stimulator (HNS) or oral appliance device treatment with use \> 4 hours per day for 30% of days within 3 months of enrollment. HNS use will be determined by device download and oral appliance use by self-report.
• History of upper airway surgery for OSA (except adenotonsillectomy).
• Central or mixed apneas \>25% of respiratory events on diagnostic polysomnography.
• Arterial oxygen saturation \< 75% for \> 5% sleep time on pretreatment polysomnography.
• Body mass index \> 45 kg/m2.
• If post-bariatric surgery, weight must be stable ±5% (per electronic medical records) for at least 6 months before the first dose of the study drug.
• Active enrollment in a weight loss program.
• Shiftwork within 3 months of enrollment.
• High-risk occupation: commercial driver and pilot.
• Motor vehicle accident or near-miss incident within 1 year of enrollment.
• Current drug or habitual alcohol use or positive urine drug screen.
• Comorbid medical and psychiatric disorders:
• Primary sleep disorders: e.g., narcolepsy, restless legs syndrome.
• Uncontrolled mood disorder or a diagnosis of schizophrenia.

Sponsors & Collaborators

• VA Office of Research and Development: lead
• University of Illinois at Chicago: collaborator

Study Sites (1)

Jesse Brown VA Medical Center, Chicago, IL

Chicago, Illinois, 60612, United States

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Apnea Syndromes

Interventions

Dronabinol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Bharati Prasad, MD

  Jesse Brown VA Medical Center, Chicago, IL

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bharati Prasad, MD

CONTACT

(312) 996-8433; bharati.prasad@va.gov

Karen M Lenehan

CONTACT

(312) 569-6343; Karen.Lenehan@va.gov

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 120 Veterans will be screened and enrolled to achieve 45 participants completing the study. All participants will receive oral Dronabinol treatment nightly for two weeks.

Study Record Dates

• First Submitted: June 21, 2024
• First Posted: June 27, 2024
• Study Start: August 25, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)