Dronabinol On the Pain Experience (DOPE)

May 22, 2025 updated by: John Andrew Harvin, The University of Texas Health Science Center, Houston

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

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)

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

484

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas Health Science Center at Houston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard of Care
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.
Experimental: Standard of Care + Dronabinol
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Morphine Milligram Equivalents (MME) Per Day
Time Frame: From time of admission to time of discharge (about 11 days after admission)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Morphine Milligram Equivalents (MME) Over Hospital Stay
Time Frame: From time of admission to time of discharge (about 11 days after admission)
This will be calculated by calculated by taking the total of MMEs from all opioids received
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)
Time Frame: From time of admission to time of discharge (about 11 days after admission)
This is a 4 item questionnaire and each is scored from 0(no pain) to 10( as bad as it could be, nothing else matters), enhanced with functional word descriptor anchors at each pain level and "traffic light" color coded bars to delineate levels of pain; mild (1 to 4, green), moderate (5 to 6, yellow), and severe (7 to 10, red) pain a higher number indicating more pain Average pain score during the course of the hospital stay will be reported.
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
Time Frame: Discharge (about 11 days after admission)
Discharge (about 11 days after admission)
Number of Participants Discharged Form Hospital Without a Prescription for an Opioid Medication
Time Frame: Discharge (about 11 days after admission)
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.
Time Frame: From time of admission to time of discharge (about 11 days after admission)
From time of admission to time of discharge (about 11 days after admission)
Hospital Length of Stay
Time Frame: From time of admission to time of discharge (about 11 days after admission)
From time of admission to time of discharge (about 11 days after admission)
Number of Hospital Free Days
Time Frame: 30 days
This will be calculated as (30 days-length of stay (LOS))
30 days
ICU Length of Stay (Participants With >0 ICU Days)
Time Frame: From time of admission to ICU to time of discharge from ICU (about 12 days after admission)
From time of admission to ICU to time of discharge from ICU (about 12 days after admission)
Number of Days on a Ventilator (Participants With > 0 Days on a Ventilator)
Time Frame: From time of intubation to time of extubation (about 14 days after admission)
From time of intubation to time of extubation (about 14 days after admission)
Number of ICU Free Days (Participants With >0 ICU Days)
Time Frame: 30 days
This will be calculated as (30 days-number of days in ICU)
30 days
Number of Ventilator Free Days (Participants With >0 Days on a Ventilator)
Time Frame: 30 days
This will be calculated as (30 days-number of days spent on ventilator)
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Collaborators

The Eastern Association for the Surgery of Trauma

Investigators

  • Principal Investigator: John Harvin, MD, FACS, The University of Texas Health Science Center, Houston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 27, 2023

Primary Completion (Actual)

April 29, 2024

Study Completion (Actual)

April 29, 2024

Study Registration Dates

First Submitted

April 6, 2023

First Submitted That Met QC Criteria

April 6, 2023

First Posted (Actual)

April 20, 2023

Study Record Updates

Last Update Posted (Actual)

June 11, 2025

Last Update Submitted That Met QC Criteria

May 22, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC-MS-22-0499

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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