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Dronabinol for Pain Management in Traumatic Injury (DOPE Trial)
Phase 4
Recruiting
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
DOPE Trial 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.Check my eligibility
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.See study design
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.
DOPE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from time of intubation to time of extubation (about 1-2 days after admission)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from time of intubation to time of extubation (about 1-2 days after admission)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with reduction in opioid exposure measured by morphine milligram equivalents (MME) per day
Secondary outcome measures
Hospital length of stay
ICU length of stay
Number of ICU free days
+8 moreDOPE 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
2019
Completed Phase 4
~15850
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
904 Previous Clinical Trials
320,296 Total Patients Enrolled
John Harvin, MD, FACSPrincipal InvestigatorThe University of Texas Health Science Center, Houston
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently under observation in a hospital.I have an injury that is not recent or severe.I was admitted to the hospital for a primary burn injury.I have been discharged from the emergency department.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Strategy #1
- Group 2: Treatment Strategy #2
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Treatment Strategy #2 received regulatory clearance from the FDA?
"Treatment Strategy #2 has been given a safety rating of 3 due to it being in the final stages, or Phase 4, of clinical trials. This indicates that this method has already received approval from governing bodies."
Answered by AI
Might I be eligible to join this trial?
"To be enrolled in this trial, potential participants must have experienced a traumatic injury and be between 16-80 years old. 664 individuals will comprise the full study cohort."
Answered by AI
Are there any open enrollment opportunities for this clinical trial?
"As documented on clinicaltrials.gov, this trial is not presently enrolling participants. The research was initially posted in May of 2023 and subsequently amended a month later. Nevertheless, there are 15 other studies that have opened their recruitment programs to patients at the moment."
Answered by AI
For whom is this research endeavor available?
"This clinical research requires participants to be between the ages of 16 and 80. For minors, 5 separate trials are available while there are 12 other options for seniors aged over 65."
Answered by AI
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