Evaluation of Dronabinol For Acute Pain Following Traumatic Injury (NCT03928015) | Clinical Trial Compass
WithdrawnPhase 2
Evaluation of Dronabinol For Acute Pain Following Traumatic Injury
Stopped: This trial did not enroll subjects. After initial approval we procured an appropriate placebo. Before IRB the amendment was approved, the COVID-19 pandemic placed a hold on all non-essential research activity at the enrolling hospital.
United States0Started 2019-10-01
Plain-language summary
Single center, non-blinded, randomized controlled trial. Enrollment is based on ≥50 MME within 24 hours of admission, followed by a 24 hour screening/randomization window and a participation period extending through the acute hospitalization period.
A total of 122 adult patients admitted with a traumatic injury will be randomized 1:1 across 2 study arms: adjunctive dronabinol or systemic analgesics only. Patients randomized to the dronabinol arm should receive their first dose within 12 hours of randomization; patients will also receive PRN as needed systemic analgesics for pain. Except for the analgesia protocol, all other interventions will be equivalent for participants in both arms.
The clinical effects of analgesia treatment arm will be evaluated during the acute hospitalization (hospital admission through discharge or death). The primary efficacy endpoint will be assessed starting at 48 hours after randomization and carried through to discharge.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female, 18 years to 65 years old (inclusive)
. Index admission for traumatic injury
. High initial morphine equivalent use ≥ 50 mg in the first 24 hours from admission
. Willing to divulge habitual marijuana usage (yes or no. Yes, habitual/chronic usage; no, recreational, former, or never usage)
Exclusion criteria
. Patients on a pain management agreement
. Patients who are nil per os (NPO) at the time of randomization or are expected to be NPO within the next 48 hours
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Morphine equivalent use
Timeframe: Post-randomization (48 hours after randomization) - pre-randomization (24 hours prior to randomization)