Overview

Evaluation of Dronabinol For Acute Pain Following Traumatic Injury

Status:
Terminated
Trial end date:
2021-06-29
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Centura Health
Treatments:
Analgesics
Dronabinol
Criteria
Inclusion Criteria:

1. Male or female, 18 years to 65 years old (inclusive)

2. Index admission for traumatic injury

3. High initial morphine equivalent use ≥ 50 mg in the first 24 hours from admission

4. Willing to divulge habitual marijuana usage (yes or no. Yes, habitual/chronic usage;
no, recreational, former, or never usage)

Exclusion Criteria:

1. Patients on a pain management agreement

2. Patients who are nil per os (NPO) at the time of randomization or are expected to be
NPO within the next 48 hours

3. Patients who have received or are expected to receive neuraxial/locoregional blocks
for pain within the next 48 hours

4. Known allergy or previous hypersensitivity reaction to dronabinol or sesame oil

5. Patients prescribed dronabinol between arrival and prior to screening/randomization

6. Pregnancy or breast feeding

7. Incarceration