Dronabinol On the Pain Experience

Trauma Injury Clinical Trial

— DOPE  

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT05820685
• Other study ID #: HSC-MS-22-0499
• Status: Suspended
• Phase: Phase 4
• Start date: July 27, 2023
• Est. completion date: October 30, 2024

Study information

• Verified date: May 2024
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 664
• Est. completion date: October 30, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Trauma Injury

Intervention

Drug:
• Standard of care
Participants in this arm will get acetaminophen 1000 mg every six hours, naproxen 500 mg every 12 hours, gabapentin 300 mg every eight hours, and Tramadol 50 mg every six hours as needed for breakthrough pain
• Dronabinol
Participants in this arm will get Dronabinol 10 mg in addition to standard of care pain medication as needed for breakthrough pain

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	The Eastern Association for the Surgery of Trauma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with reduction in opioid exposure measured by 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 5 days after admission)
Secondary	Total MMEs over hospital stay	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 5 days after admission)
Secondary	Pain as assessed by the defense and veterans pain rating scale (DVPRS)	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 5 days after admission)
Secondary	Number of participants discharged form hospital with a prescription for an opioid medication		Discharge (about 5 days after admission)
Secondary	Number of participants discharged form hospital without a prescription for an opioid medication		Discharge (about 5 days after admission)
Secondary	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 5 days after admission)
Secondary	Hospital length of stay		From time of admission to time of discharge (about 5 days after admission)
Secondary	ICU length of stay		From time of admission to ICU to time of discharge from ICU (about 1-2 days after admission)
Secondary	Number of days on a ventilator		From time of intubation to time of extubation (about 1-2 days after admission)
Secondary	Number of hospital free days	This will be calculated as (30 days-length of stay (LOS))	From time of admission to time of discharge (about 5 days after admission)
Secondary	Number of ICU free days	This will be calculated as (30 days-number of days in ICU)	From time of admission to ICU to time of discharge from ICU (about 1-2 days after admission)
Secondary	Number of Ventilator free days	This will be calculated as (30 days-number of days spent on ventilator)	From time of intubation to time of extubation (about 1-2 days after admission)