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Dronabinol On the Pain Experience

NCT05820685 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 484

Last updated 2025-06-11

Study results available
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Summary

The purpose of this study is to identify the effect dronabinol has on opioid exposure when used as an adjunct to the current standard multi-modal pain regimen (MMPR)

Conditions

  • Trauma Injury

Interventions

DRUG

Standard of Care (acetaminophen +naproxen +gabapentin + as needed oxycodone or Tramadol)

Participants will receive acetaminophen 1000 mg every six hours, naproxen 500 mg every 12 hours, and gabapentin 300 mg every eight hours. Participants will also receive Oxycodone 5 mg or Tramadol 50 mg every six hours as needed for breakthrough pain. Providers will have the ability to adjust this pain regimen based on clinical judgement.

DRUG

Dronabinol

Participants will receive Dronabinol 10 mg every 12 hours scheduled. Providers will have the ability to adjust this pain regimen based on clinical judgement.

Sponsors & Collaborators

  • The Eastern Association for the Surgery of Trauma

    collaborator UNKNOWN

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • John Harvin, MD, FACS · The University of Texas Health Science Center, Houston

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-27
Primary Completion
2024-04-29
Completion
2024-04-29
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05820685 on ClinicalTrials.gov