Trauma InjuryPhase 4DOPENCT05820685
Dronabinol On the Pain Experience
A Phase 4 study testing Dronabinol in people with Trauma Injury, run by The University of Texas Health Science Center, Houston at 1 site in United States.
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) Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Trauma Injury
- What is being tested?
- Dronabinol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 484 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jul 2023to 29 Apr 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients admitted to the floor, Surgical Intermediate Medical Unit (SIMU), Shock-Trauma ICU (STICU) at Memorial Herman Hospital-Texas Medical Center(MHH-TMC)
Who cannot join
- Pregnant
- Prisoner
- Patients placed in observation unit
- Non-acute trauma
- Admitted with primary burn injury
- Expired prior to admission
Show all 9Show fewer
- Moribund
- Discharge from emergency department
- Left against medical advice
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
Official title: 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)
- Conditions
- Trauma Injury
- Being tested
- Standard of Care (acetaminophen +naproxen +gabapentin + as needed oxycodone or Tramadol), Dronabinol
- Medical subject headings
- Accidental Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
DronabinolDrug
Participants will receive Dronabinol 10 mg every 12 hours scheduled. Providers will have the ability to adjust this pain regimen based on clinical judgement.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | Not described Receives: Drug: Standard of Care (acetaminophen +naproxen +gabapentin + as needed oxycodone or Tramadol) |
| Standard of Care + Dronabinol | Experimental | Not described Receives: Drug: Standard of Care (acetaminophen +naproxen +gabapentin + as needed oxycodone or Tramadol); Drug: Dronabinol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From time of admission to time of discharge (about 11 days after admission)
Secondary outcomes (11)
Total Morphine Milligram Equivalents (MME) Over Hospital Stay
This will be calculated by calculated by taking the total of MMEs from all opioids received
Measured: 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)
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.
Measured: 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
Measured: Discharge (about 11 days after admission)
Number of Participants Discharged Form Hospital Without a Prescription for an Opioid Medication
Measured: 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.
Measured: From time of admission to time of discharge (about 11 days after admission)
Hospital Length of Stay
Measured: From time of admission to time of discharge (about 11 days after admission)
Number of Hospital Free Days
This will be calculated as (30 days-length of stay (LOS))
Measured: 30 days
ICU Length of Stay (Participants With >0 ICU Days)
Measured: 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)
Measured: From time of intubation to time of extubation (about 14 days after admission)
Number of ICU Free Days (Participants With >0 ICU Days)
This will be calculated as (30 days-number of days in ICU)
Measured: 30 days
Number of Ventilator Free Days (Participants With >0 Days on a Ventilator)
This will be calculated as (30 days-number of days spent on ventilator)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study start27 Jul 2023
- Primary completion29 Apr 2024
- Study completion29 Apr 2024
Why it stopped: Study concluded because of drug shortage
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Trauma InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 484 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Collaborators
- The Eastern Association for the Surgery of Trauma
- Responsible party
- Principal investigator, John Andrew Harvin, The University of Texas Health Science Center, Houston
- Investigators
- John Harvin, MD, FACS, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05820685
- Sponsor's protocol ID
- HSC-MS-22-0499
- Acronym
- DOPE
- Status last verified
- May 2025
- First submitted
- 6 Apr 2023
- Last updated
- 11 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dronabinol On the Pain Experience (DOPE): a Pragmatic Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05820685
- Acronym / sponsor ID
- DOPE / HSC-MS-22-0499
- Conditions
- Trauma Injury
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study concluded because of drug shortage
- Enrolment
- 484 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- The Eastern Association for the Surgery of Trauma
- Study start
- 27 Jul 2023 (actual)
- Primary completion
- 29 Apr 2024 (actual)
- Study completion
- 29 Apr 2024 (actual)
- First posted
- 20 Apr 2023 (actual)
- Results
- Posted 11 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients admitted to the floor, Surgical Intermediate Medical Unit (SIMU), Shock-Trauma ICU (STICU) at Memorial Herman Hospital-Texas Medical Center(MHH-TMC)
Key exclusion criteria (9 listed)
- Pregnant
- Prisoner
- Patients placed in observation unit
- Non-acute trauma
- Admitted with primary burn injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Standard of Care, Standard of Care + Dronabinol |
| DronabinolParticipants will receive Dronabinol 10 mg every 12 hours scheduled. Providers will have the ability to adjust this pain regimen based on clinical judgement. | Drug | Standard of Care + Dronabinol |
Primary outcome
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
11 secondary outcomes
Total Morphine Milligram Equivalents (MME) Over Hospital Stay
Time frame: 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)
Number of Participants Discharged Form Hospital With a Prescription for an Opioid Medication
Time frame: 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)
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)
Hospital Length of Stay
Time frame: From time of admission to time of discharge (about 11 days after admission)
Number of Hospital Free Days
Time frame: 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)
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)
Number of ICU Free Days (Participants With >0 ICU Days)
Time frame: 30 days
Number of Ventilator Free Days (Participants With >0 Days on a Ventilator)
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Harvin, MD, FACS principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dronabinol in people with Trauma Injury, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Morphine Milligram Equivalents (MME) Per Day (time frame: From time of admission to time of discharge (about 11 days after admission)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2025; AzTrials last refreshed its copy on 31 Oct 2026.