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Dronabinol for Pain Management in Traumatic Injury (DOPE Trial)

Phase 4
Waitlist Available
Led By John Harvin, MD, FACS
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from time of admission to icu to time of discharge from icu (about 1-2 days after admission)
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Drug Has Already Been Approved

Summary

This trial will test if an opioid-reducing drug, dronabinol, helps lower opioid use when added to existing pain treatments.

Who is the study for?
This trial is for patients at Memorial Herman Hospital-Texas Medical Center who are admitted with traumatic injuries and receiving standard pain management. It's not open to those who left against medical advice, prisoners, burn injury victims, non-acute trauma cases, the very ill (moribund), or pregnant women.
What is being tested?
The study is testing if Dronabinol can reduce the need for opioids in managing pain when added to the usual multi-modal pain regimen. Patients will either receive this additional treatment or continue with their standard care without it.
What are the potential side effects?
Dronabinol may cause dizziness, mood changes, sleepiness, confusion, hallucinations, low blood pressure upon standing up. These side effects vary from person to person.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from time of intubation to time of extubation (about 1-2 days after admission)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from time of intubation to time of extubation (about 1-2 days after admission) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of participants with reduction in opioid exposure measured by morphine milligram equivalents (MME) per day
Secondary study objectives
Number of ICU free days
Number of Ventilator free days
Number of hospital free days
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Treatment Strategy #2Experimental Treatment2 Interventions
Group II: Treatment Strategy #1Active Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Standard of care
2020
Completed Phase 4
~17710
Dronabinol
2003
Completed Phase 4
~2080

Find a Location

Who is running the clinical trial?

The Eastern Association for the Surgery of TraumaUNKNOWN
The University of Texas Health Science Center, HoustonLead Sponsor
946 Previous Clinical Trials
343,625 Total Patients Enrolled
John Harvin, MD, FACSPrincipal InvestigatorThe University of Texas Health Science Center, Houston

Media Library

Treatment Strategy #2 Clinical Trial Eligibility Overview. Trial Name: NCT05820685 — Phase 4
Injury Research Study Groups: Treatment Strategy #1, Treatment Strategy #2
Injury Clinical Trial 2023: Treatment Strategy #2 Highlights & Side Effects. Trial Name: NCT05820685 — Phase 4
Treatment Strategy #2 2023 Treatment Timeline for Medical Study. Trial Name: NCT05820685 — Phase 4
~295 spots leftby Nov 2025
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