Evaluation of Dronabinol For Acute Pain Following Traumatic Injury

Study Overview
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Brief Summary
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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.

Detailed Description
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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 trauma patients 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, starting with 5mg BID and adjusting within the range of 2.5mg - 10mg BID. Patients randomized to dronabinol will also receive PRN as needed systemic analgesics for pain. Except for the analgesia protocol, all other interventions are performed in the context of everyday clinical practice, and thus 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. The primary trial objective is to evaluate the efficacy of adjunctive dronabinol versus no adjunctive dronabinol (systemic analgesics only) on reduction in opioids in adult patients with traumatic injury. The secondary trial objectives include: evaluation of the efficacy of dronabinol versus no dronabinol (systemic analgesics only) for pain numeric rating scale (NRS) scores, hospital length of stay, complications, and adverse effects associated with analgesia.

Official Title
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A Single Centre Randomized Controlled Trial To Evaluate Dronabinol For Acute Pain Management In Adults With Traumatic Injury

Conditions
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Traumatic Injury, Pain, Acute

Intervention / Treatment
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* Drug: Adjunctive dronabinol
* Drug: Systemic analgesics


Participation Criteria
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Eligibility Criteria
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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 Patients who have received or are expected to receive neuraxial/locoregional blocks for pain within the next 48 hours Known allergy or previous hypersensitivity reaction to dronabinol or sesame oil Patients prescribed dronabinol between arrival and prior to screening/randomization Pregnancy or breast feeding Incarceration

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Open label, randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adjunctive dronabinol<br>Dronabinol 5mg BID and adjusting within the range of 2.5mg - 10mg BID, as an adjunct to systemic analgesics | Drug: Adjunctive dronabinol<br>* 5mg BID and adjusting within the range of 2.5mg - 10mg BID, minimum of 48 hours, as an adjunct to systemic analgesics<br>* Other names: Marinol;|
| Active Comparator: Systemic analgesics<br>Systemic analgesics only | Drug: Systemic analgesics<br>* multimodal analgesia including opioid and non-opioid analgesics<br>* Other names: standard of care;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morphine equivalent use | Change in morphine milligram equivalent (MME) use | Post-randomization (48 hours after randomization) - pre-randomization (24 hours prior to randomization) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain scores | Change in pain numeric rating scale (NRS) score, which is on a scale of 0-10. A value of 0 indications no pain and a value of 10 indicates highest level of pain | Post-randomization (48 hours after randomization) - pre-randomization (24 hours prior to randomization) | 
| Incidence of complications | Analgesic complications and other hospital complications | Acute hospitalization period | 
| LOS | Hospital LOS | Acute hospitalization period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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marijuana, dronabinol, morphine milligram equivalents