Evaluation of Dronabinol For Acute Pain Following Traumatic Injury

Phase 2

Withdrawn

• Conditions: Pain, Acute; Traumatic Injury
• Interventions: Drug: Systemic analgesics; Drug: Adjunctive dronabinol

• Registration Number: NCT03928015
• Lead Sponsor: CommonSpirit Health

Brief 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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2019-04-09
• Study First Submitted QC: 2019-04-24
• Study First Posted: 2019-04-25
• Study Start: 2019-10-01
• Primary Completion: 2021-06-29
• Study Completion: 2021-06-29
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-27
• Last Update Posted: 2022-07-28

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Systemic analgesics	Systemic analgesics	Systemic analgesics only
Adjunctive dronabinol	Adjunctive dronabinol	Dronabinol 5mg BID and adjusting within the range of 2.5mg - 10mg BID, as an adjunct to systemic analgesics

Primary Outcome Measures

Name	Time	Method
Morphine equivalent use	Post-randomization (48 hours after randomization) - pre-randomization (24 hours prior to randomization)	Change in morphine milligram equivalent (MME) use

Secondary Outcome Measures

Name	Time	Method
LOS	Acute hospitalization period	Hospital LOS
Pain scores	Post-randomization (48 hours after randomization) - pre-randomization (24 hours prior to randomization)	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
Incidence of complications	Acute hospitalization period	Analgesic complications and other hospital complications

Trial Locations

Locations (1)

St. Anthony Hospital; 🇺🇸 Lakewood, Colorado, United States