Dronabinol On the Pain Experience

NCT05820685 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: HSC-MS-22-0499
• Study Type: interventional
• Target: 484
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Total Morphine Milligram Equivalents (MME) Per Day

  This will be calculated by calculated by taking the total of MMEs from all opioids received and dividing by length of stay

  From time of admission to time of discharge (about 11 days after admission)

Secondary Outcomes (11)

• Total Morphine Milligram Equivalents (MME) Over Hospital Stay

  From time of admission to time of discharge (about 11 days after admission)

• Pain as Assessed by the Defense and Veterans Pain Rating Scale (DVPRS)

  From time of admission to time of discharge (about 11 days after admission)

• Number of Participants Discharged Form Hospital With a Prescription for an Opioid Medication

  Discharge (about 11 days after admission)

• Number of Participants Discharged Form Hospital Without a Prescription for an Opioid Medication

  Discharge (about 11 days after admission)

• Number of Participants That Have Incidences of Opioid-related Complications, Such as Ileus, Aspiration, Unplanned Intubation, Unplanned Admission to an Intensive Care Unit, and Use of an Opioid-reversal Agent.

  From time of admission to time of discharge (about 11 days after admission)

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

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

Standard of Care + Dronabinol

EXPERIMENTAL

Drug: Standard of Care (acetaminophen +naproxen +gabapentin + as needed oxycodone or Tramadol); Drug: Dronabinol

Interventions

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

Dronabinol 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.

Standard of Care + Dronabinol

Eligibility Criteria

• Age: 16 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• The Eastern Association for the Surgery of Trauma: collaborator

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Accidental Injuries

Interventions

Standard of Care; Tramadol; Dronabinol

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids; Cannabinoids; Terpenes; Hydrocarbons

Results Point of Contact

• Title: John Harvin, MD, FACS
• Organization: The University of Texas Health Science Center at Houston

John.Harvin@uth.tmc.edu

713-500-7244

Study Officials

• John Harvin, MD, FACS

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 6, 2023
• First Posted: April 20, 2023
• Study Start: July 27, 2023
• Primary Completion: April 29, 2024
• Study Completion: April 29, 2024
• Last Updated: June 11, 2025
• Results First Posted: June 11, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)