Dronabinol for Sleep Apnea

(DROSA Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Bharati Prasad, MD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: VA Office of Research and Development

No Placebo Group

Approved in 6 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for individuals with obstructive sleep apnea (OSA). Specific eligibility criteria are not provided, but typically participants would need a confirmed diagnosis of OSA and be in stable health to participate.

Inclusion Criteria

AHI 15-50 per hour on pre-treatment polysomnography

I am between 18 and 65 years old.

Exclusion Criteria

Active enrollment in a weight loss program

I have had surgery for sleep apnea, not including adenotonsillectomy.

My weight has been stable for 6 months after bariatric surgery.

Participant Groups

The trial is testing the effectiveness of Dronabinol, an oral medication, in treating OSA. It's an open-label study where all participants will receive the drug for two weeks with sleep studies before and after treatment to assess changes.

Group I: Single group Experimental Treatment 1 Intervention

Open label Dronabinol treatment for two weeks.

Dronabinol is already approved in United States, United States, Australia, Canada for the following indications:

🇺🇸 Approved in United States as Marinol for:

• HIV/AIDS-induced anorexia
• Chemotherapy-induced nausea and vomiting
• Sleep apnea

🇺🇸 Approved in United States as Syndros for:

• HIV/AIDS-induced anorexia
• Chemotherapy-induced nausea and vomiting

🇦🇺 Approved in Australia as Marinol for:

• HIV/AIDS-induced anorexia
• Chemotherapy-induced nausea and vomiting

🇨🇦 Approved in Canada as REDUVO for:

• HIV/AIDS-induced anorexia
• Chemotherapy-induced nausea and vomiting

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Jesse Brown VA Medical Center, Chicago, IL Chicago, IL

Who Is Running the Clinical Trial?

VA Office of Research and Development Lead Sponsor

University of Illinois at Chicago Collaborator

References