Evaluation of Dronabinol For Acute Pain Following Traumatic Injury

Pain, Acute Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03928015
• Other study ID #: 1382279
• Status: Withdrawn
• Phase: Phase 2
• Start date: October 1, 2019
• Est. completion date: June 29, 2021

Study information

• Verified date: July 2022
• Source: Centura Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 29, 2021
• Est. primary completion date: June 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Pain, Acute
• Traumatic Injury
• Wounds and Injuries

Intervention

Drug:
• Adjunctive dronabinol
5mg BID and adjusting within the range of 2.5mg - 10mg BID, minimum of 48 hours, as an adjunct to systemic analgesics
• Systemic analgesics
multimodal analgesia including opioid and non-opioid analgesics

Locations

Country	Name	City	State
United States	St. Anthony Hospital	Lakewood	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Centura Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morphine equivalent use	Change in morphine milligram equivalent (MME) use	Post-randomization (48 hours after randomization) - pre-randomization (24 hours prior to randomization)
Secondary	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)
Secondary	Incidence of complications	Analgesic complications and other hospital complications	Acute hospitalization period
Secondary	LOS	Hospital LOS	Acute hospitalization period