NCT05820685

Dronabinol On the Pain Experience

Dronabinol On the Pain Experience (DOPE): a Pragmatic Randomized Clinical Trial

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 484 (actual)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 16 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to identify the effect dronabinol has on opioid exposure when used as an adjunct to the current standard multi-modal pain regimen (MMPR)

Conditions

• Trauma Injury

Interventions

Type	Name	Description
DRUG	Standard of Care (acetaminophen +naproxen +gabapentin + as needed oxycodone or Tramadol)	Participants will receive acetaminophen 1000 mg every six hours, naproxen 500 mg every 12 hours, and gabapentin 300 mg every eight hours. Participants will also receive Oxycodone 5 mg or Tramadol 50 mg every six hours as needed for breakthrough pain. Providers will have the ability to adjust this pain regimen based on clinical judgement.
DRUG	Dronabinol	Participants will receive Dronabinol 10 mg every 12 hours scheduled. Providers will have the ability to adjust this pain regimen based on clinical judgement.

Timeline

• Start date: 2023-07-27
• Primary completion: 2024-04-29
• Completion: 2024-04-29
• First posted: 2023-04-20
• Last updated: 2025-06-11
• Results posted: 2025-06-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study