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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.

Evaluation of Dronabinol For Acute Pain Following Traumatic Injury

Clinicaltrials.gov identifier NCT03928015

Recruitment Status Enrolling by invitation

First Posted April 25, 2019

Last update posted January 27, 2020

Study Description

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.

  • Condition or Disease:Traumatic Injury
    Pain, Acute
  • Intervention/Treatment: Drug: Adjunctive dronabinol
    Drug: Systemic analgesics
  • Phase: Phase 2
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 Design
  • Study Type: Interventional
  • Estimated Enrollment: 122 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Intervention Model Description: Open label, randomized controlled trial
  • Masking: None (Open Label) ()
  • Primary Purpose: Supportive Care
  • Official Title: A Single Centre Randomized Controlled Trial To Evaluate Dronabinol For Acute Pain Management In Adults With Traumatic Injury
  • Actual Study Start Date: October 2019
  • Estimated Primary Completion Date: May 2021
  • Estimated Study Completion Date: July 2021
Arms and interventions
Arm Intervention/treatment
Experimental: Adjunctive dronabinol
Dronabinol 5mg BID and adjusting within the range of 2.5mg - 10mg BID, as an adjunct to systemic analgesics
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
Active Comparator: Systemic analgesics
Systemic analgesics only
Drug: Systemic analgesics
multimodal analgesia including opioid and non-opioid analgesics
Outcome Measures
  • Primary Outcome Measures: 1. Morphine equivalent use [ Time Frame: Post-randomization (48 hours after randomization) - pre-randomization (24 hours prior to randomization) ]
    Change in morphine milligram equivalent (MME) use
  • Secondary Outcome Measures: 1. Pain scores [ Time Frame: 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
  • 2. Incidence of complications [ Time Frame: Acute hospitalization period ]
    Analgesic complications and other hospital complications
  • 3. LOS [ Time Frame: Acute hospitalization period ]
    Hospital LOS
Eligibility Criteria
  • Ages Eligible for Study: 18 to 65 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
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

Contacts and Locations
Contacts
Locations

United States, Colorado
St. Anthony Hospital
Lakewood

Sponsors and Collaborators

Centura Health

Investigators

Principal Investigator: Claire J Swartwood, PharmD Centura Health - St. Anthony Hospital

More Information
  • Responsible Party: Centura Health
  • ClinicalTrials.gov Identifier: NCT03928015 History of Changes
  • Other Study ID Numbers: 1382279
  • First Posted: April 25, 2019 Key Record Dates
  • Last Update Posted: January 27, 2020
  • Last Verified: January 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Product Manufactured in and Exported from the U.S.: Yes
  • Keywords provided by Centura Health: marijuana
    dronabinol
    morphine milligram equivalents
  • Additional relevant MeSH terms: Acute Pain Wounds and Injuries