Evaluation of Dronabinol For Acute Pain Following Traumatic Injury

NCT03928015 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: 1382279
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Injury; Pain, Acute

Keywords

marijuana; dronabinol; morphine milligram equivalents

Outcome Measures

Primary Outcomes (1)

• Morphine equivalent use

  Change in morphine milligram equivalent (MME) use

  Post-randomization (48 hours after randomization) - pre-randomization (24 hours prior to randomization)

Secondary Outcomes (3)

• Pain scores

  Post-randomization (48 hours after randomization) - pre-randomization (24 hours prior to randomization)

• Incidence of complications

  Acute hospitalization period

• LOS

  Acute hospitalization period

Study Arms (2)

Adjunctive dronabinol

EXPERIMENTAL

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

Drug: Adjunctive dronabinol

Systemic analgesics

ACTIVE COMPARATOR

Systemic analgesics only

Drug: Systemic analgesics

Interventions

Adjunctive dronabinol DRUG

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

Also known as: Marinol

Adjunctive dronabinol

Systemic analgesics DRUG

multimodal analgesia including opioid and non-opioid analgesics

Also known as: standard of care

Systemic analgesics

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, 18 years to 65 years old (inclusive)
• Index admission for traumatic injury
• High initial morphine equivalent use ≥ 50 mg in the first 24 hours from admission
• Willing to divulge habitual marijuana usage (yes or no. Yes, habitual/chronic usage; no, recreational, former, or never usage)

You may not qualify if:

• Patients on a pain management agreement
• Patients who are nil per os (NPO) at the time of randomization or are expected to be NPO within the next 48 hours
• Patients who have received or are expected to receive neuraxial/locoregional blocks for pain within the next 48 hours
• Known allergy or previous hypersensitivity reaction to dronabinol or sesame oil
• Patients prescribed dronabinol between arrival and prior to screening/randomization
• Pregnancy or breast feeding
• Incarceration

Sponsors & Collaborators

• CommonSpirit Health: lead

Study Sites (1)

St. Anthony Hospital

Lakewood, Colorado, 80228, United States

Location

Related Publications (1)

• 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.

  PMID: 32178232 DERIVED

MeSH Terms

Conditions

Wounds and Injuries; Acute Pain; Marijuana Abuse

Interventions

Dronabinol; Standard of Care

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Claire J Swartwood, PharmD

  Centura Health - St. Anthony Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pharmacy Residency Program Director

Model Details: Open label, randomized controlled trial

Study Record Dates

• First Submitted: April 9, 2019
• First Posted: April 25, 2019
• Study Start: October 1, 2019
• Primary Completion: June 29, 2021
• Study Completion: June 29, 2021
• Last Updated: July 28, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)