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
• Sponsor: Centura Health
• Information provided by (Responsible Party): Claire Swartwood, Centura Health

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	Intervention/treatment	Phase
Traumatic Injury; Pain, Acute	Drug: Adjunctive dronabinol; Drug: Systemic analgesics	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 (Clinical Trial)
• 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 1, 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; Other Name: Marinol
Active Comparator: Systemic analgesics; Systemic analgesics only	Drug: Systemic analgesics; multimodal analgesia including opioid and non-opioid analgesics; Other Name: standard of care

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 Years 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

Locations

United States, Colorado

St. Anthony Hospital

Lakewood, Colorado, United States, 80228

Sponsors and Collaborators

Centura Health

Investigators

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Swartwood C, Salottolo K, Madayag R, Bar-Or D. Efficacy of Dronabinol for Acute Pain Management in Adults with Traumatic Injury: Study Protocol of A Randomized Controlled Trial. Brain Sci. 2020 Mar 12;10(3). pii: E161. doi: 10.3390/brainsci10030161.

• Responsible Party: Claire Swartwood, Pharmacy Residency Program Director, Centura Health
• ClinicalTrials.gov Identifier: NCT03928015
• Other Study ID Numbers: 1382279
• First Posted: April 25, 2019
• 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.: No

Keywords provided by Claire Swartwood, Centura Health:

marijuana; dronabinol; morphine milligram equivalents

Additional relevant MeSH terms:

Acute Pain; Wounds and Injuries; Pain; Neurologic Manifestations; Analgesics; Dronabinol; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Hallucinogens; Psychotropic Drugs; Analgesics, Non-Narcotic; Cannabinoid Receptor Agonists; Cannabinoid Receptor Modulators; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists