Evaluation of Dronabinol For Acute Pain Following Traumatic Injury

NCT ID: NCT03928015

Last Updated: 2022-07-28

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-01
• Study Completion Date: 2021-06-29

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.

Conditions

Traumatic Injury; Pain, Acute

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Adjunctive dronabinol

Dronabinol 5mg BID and adjusting within the range of 2.5mg - 10mg BID, as an adjunct to systemic analgesics

Group Type: EXPERIMENTAL

Adjunctive dronabinol

Intervention Type: DRUG

5mg BID and adjusting within the range of 2.5mg - 10mg BID, minimum of 48 hours, as an adjunct to systemic analgesics

Systemic analgesics

Systemic analgesics only

Group Type: ACTIVE_COMPARATOR

Systemic analgesics

Intervention Type: DRUG

multimodal analgesia including opioid and non-opioid analgesics

Interventions

Adjunctive dronabinol

5mg BID and adjusting within the range of 2.5mg - 10mg BID, minimum of 48 hours, as an adjunct to systemic analgesics

Intervention Type: DRUG

Systemic analgesics

multimodal analgesia including opioid and non-opioid analgesics

Intervention Type: DRUG

Other Intervention Names

Marinol; standard of care

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CommonSpirit Health

OTHER

Sponsor Role: lead

Responsible Party

Claire Swartwood

Pharmacy Residency Program Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Claire J Swartwood, PharmD

Role: PRINCIPAL_INVESTIGATOR

Centura Health - St. Anthony Hospital

Locations

St. Anthony Hospital

Lakewood, Colorado, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 32178232 (View on PubMed)

Other Identifiers

1382279

Identifier Type: -

Identifier Source: org_study_id