Trial · NCT05820685
Dronabinol On the Pain Experience
NCT05820685, Phase 4, Terminated, The University of Texas Health Science Center, Houston; results first posted 2025-06-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Dronabinol On the Pain Experience. Trials, record NCT05820685. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05820685
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dronabinol On the Pain Experience
- NCT number
- NCT05820685
- Status
- Terminated
- Phases
- Phase 4
- Enrollment
- 484 participants, actual
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Conditions
- Trauma Injury
- Interventions
- Standard of Care (acetaminophen +naproxen +gabapentin + as needed oxycodone or Tramadol), Dronabinol
- First posted
- 2023-04-20
- Last updated
- 2025-06-11
- Results first posted
- 2025-06-11
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Total Morphine Milligram Equivalents (MME) Per Day | 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 |
| Secondary | Total Morphine Milligram Equivalents (MME) Over Hospital Stay | 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 |
| Secondary | 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) | 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. |
| Secondary | Number of Participants Discharged Form Hospital With a Prescription for an Opioid Medication | Discharge (about 11 days after admission) | |
| Secondary | Number of Participants Discharged Form Hospital Without a Prescription for an Opioid Medication | Discharge (about 11 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 11 days after admission) | |
| Secondary | Hospital Length of Stay | From time of admission to time of discharge (about 11 days after admission) | |
| Secondary | Number of Hospital Free Days | 30 days | This will be calculated as (30 days-length of stay (LOS)) |
| Secondary | ICU Length of Stay (Participants With >0 ICU Days) | From time of admission to ICU to time of discharge from ICU (about 12 days after admission) | |
| Secondary | Number of Days on a Ventilator (Participants With > 0 Days on a Ventilator) | From time of intubation to time of extubation (about 14 days after admission) |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Total Morphine Milligram Equivalents (MME) Per Day | From time of admission to time of discharge (about 11 days after admission) | MME Per Day | MEDIAN | |
| SECONDARY | Total Morphine Milligram Equivalents (MME) Over Hospital Stay | From time of admission to time of discharge (about 11 days after admission) | Morphine Milligram Equivalents (MME) | MEDIAN | |
| SECONDARY | 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) | Data were not collected for this outcome measure because it was not charted by the bedside nurse. | ||
| SECONDARY | Number of Participants Discharged Form Hospital With a Prescription for an Opioid Medication | Discharge (about 11 days after admission) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants Discharged Form Hospital Without a Prescription for an Opioid Medication | Discharge (about 11 days after admission) | Participants | COUNT_OF_PARTICIPANTS | |
| 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 11 days after admission) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Hospital Length of Stay | From time of admission to time of discharge (about 11 days after admission) | days | MEDIAN | |
| SECONDARY | Number of Hospital Free Days | 30 days | Days | MEDIAN | |
| SECONDARY | ICU Length of Stay (Participants With >0 ICU Days) | From time of admission to ICU to time of discharge from ICU (about 12 days after admission) | Only the participants with \> 0 ICU days were analyzed for this outcome measure. | days | MEDIAN |
| SECONDARY | Number of Days on a Ventilator (Participants With > 0 Days on a Ventilator) | From time of intubation to time of extubation (about 14 days after admission) | Only the participants with \> 0 days on a ventilator were analyzed for this outcome measure. | days | MEDIAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Total Morphine Milligram Equivalents (MME) Per Day | Standard of Care | 15 | Inter-Quartile Range 9 to 25 | MME Per Day | |
| Total Morphine Milligram Equivalents (MME) Per Day | Standard of Care + Dronabinol | 17 | Inter-Quartile Range 10 to 26 | MME Per Day | |
| Total Morphine Milligram Equivalents (MME) Over Hospital Stay | Standard of Care | 99 | Inter-Quartile Range 50 to 197 | Morphine Milligram Equivalents (MME) | |
| Total Morphine Milligram Equivalents (MME) Over Hospital Stay | Standard of Care + Dronabinol | 99 | Inter-Quartile Range 48 to 182 | Morphine Milligram Equivalents (MME) | |
| Number of Participants Discharged Form Hospital With a Prescription for an Opioid Medication | Standard of Care | 133 | Participants | ||
| Number of Participants Discharged Form Hospital With a Prescription for an Opioid Medication | Standard of Care + Dronabinol | 144 | Participants | ||
| Number of Participants Discharged Form Hospital Without a Prescription for an Opioid Medication | Standard of Care | 102 | Participants | ||
| Number of Participants Discharged Form Hospital Without a Prescription for an Opioid Medication | Standard of Care + Dronabinol | 90 | Participants | ||
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. | Standard of Care | 10 | Participants | ||
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. | Standard of Care + Dronabinol | 13 | Participants |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Standard of Care | 241 | |
| Overall Study | STARTED | Standard of Care + Dronabinol | 243 | |
| Overall Study | COMPLETED | Standard of Care | 235 | |
| Overall Study | COMPLETED | Standard of Care + Dronabinol | 234 | |
| Overall Study | NOT COMPLETED | Standard of Care | 6 | |
| Overall Study | NOT COMPLETED | Standard of Care + Dronabinol | 9 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Unplanned intubation | General disorders | Standard of Care | 3 | 235 | |
| serious | Unplanned intubation | General disorders | Standard of Care + Dronabinol | 4 | 234 | |
| serious | Unplanned ICU | Gastrointestinal disorders | Standard of Care | 8 | 235 | |
| serious | Unplanned ICU | Gastrointestinal disorders | Standard of Care + Dronabinol | 13 | 234 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Standard of Care | 5 | 235 |
| Total, all-cause mortality | Standard of Care + Dronabinol | 4 | 234 |
| Total, other adverse events | Standard of Care | 0 | 235 |
| Total, other adverse events | Standard of Care + Dronabinol | 0 | 234 |
| Total, serious adverse events | Standard of Care | 10 | 235 |
| Total, serious adverse events | Standard of Care + Dronabinol | 13 | 234 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Standard of Care + Dronabinol vs Standard of Care: Number of Participants Discharged Form Hospital With a Prescription for an Opioid Medication | Trial comparisons |
Standard of Care + Dronabinol vs Standard of Care: 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. | Trial comparisons |
| Standard of Care + Dronabinol vs Standard of Care: Number of Participants Discharged Form Hospital Without a Prescription for an Opioid Medication | Trial comparisons |
| Standard of Care + Dronabinol vs Standard of Care: deaths from any cause | Trial comparisons |
| Standard of Care + Dronabinol vs Standard of Care: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05820685
GET https://conductscience.org/api/trials/v1/NCT05820685/results?page=2