Dronabinol On the Pain Experience

NCT ID: NCT05820685

Last Updated: 2025-06-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 484 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-27
• Study Completion Date: 2024-04-29

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard of Care

Group Type: ACTIVE_COMPARATOR

Standard of Care (acetaminophen +naproxen +gabapentin + as needed oxycodone or Tramadol)

Intervention Type: DRUG

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.

Standard of Care + Dronabinol

Group Type: EXPERIMENTAL

Standard of Care (acetaminophen +naproxen +gabapentin + as needed oxycodone or Tramadol)

Intervention Type: DRUG

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.

Dronabinol

Intervention Type: DRUG

Participants will receive Dronabinol 10 mg every 12 hours scheduled. Providers will have the ability to adjust this pain regimen based on clinical judgement.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• patients admitted to the floor, Surgical Intermediate Medical Unit (SIMU), Shock-Trauma ICU (STICU) at Memorial Herman Hospital-Texas Medical Center(MHH-TMC)

Exclusion Criteria

• Pregnant
• Prisoner
• Patients placed in observation unit
• Non-acute trauma
• Admitted with primary burn injury
• Expired prior to admission
• Moribund
• Discharge from emergency department
• Left against medical advice

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Eastern Association for the Surgery of Trauma

UNKNOWN

Sponsor Role: collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

John Andrew Harvin

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John Harvin, MD, FACS

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HSC-MS-22-0499

Identifier Type: -

Identifier Source: org_study_id