Clinical trial NCT03928015: Evaluation of Dronabinol For Acute Pain Following Traumatic Injury
Official title: A Single Centre Randomized Controlled Trial To Evaluate Dronabinol For Acute Pain Management In Adults With Traumatic Injury
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Traumatic Injury
Pain, Acute
Keywords: marijuana
dronabinol
morphine milligram equivalents
Lead sponsor: CommonSpirit Health
Sponsor class: OTHER
First posted: 2019-04-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open label, randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Morphine equivalent use
timeFrame: Post-randomization (48 hours after randomization) - pre-randomization (24 hours prior to randomization)
Secondary outcomes:
measure: Pain scores
timeFrame: Post-randomization (48 hours after randomization) - pre-randomization (24 hours prior to randomization)
measure: Incidence of complications
timeFrame: Acute hospitalization period
measure: LOS
timeFrame: Acute hospitalization period
Other outcomes:
Locations:
city: Lakewood
country: United States
facility: St. Anthony Hospital
state: Colorado
Study officials:
affiliation: Centura Health - St. Anthony Hospital
name: Claire J Swartwood, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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):161. doi: 10.3390/brainsci10030161.