Dronabinol On the Pain Experience (DOPE)

The University of Texas System (UT)

Status and phase: Terminated; Phase 4

Conditions: Trauma Injury

Treatments: Drug: Dronabinol; Drug: Standard of Care (acetaminophen +naproxen +gabapentin + as needed oxycodone or Tramadol)

Study type: Interventional

Funder types: Other

Identifiers

NCT05820685

HSC-MS-22-0499

Details and patient eligibility

About

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)

Enrollment: 484 patients

Sex: All

Ages: 16 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients admitted to the floor, Surgical Intermediate Medical Unit (SIMU), Shock-Trauma ICU (STICU) at Memorial Herman Hospital-Texas Medical Center(MHH-TMC)

Exclusion criteria

• Pregnant
• Prisoner
• Patients placed in observation unit
• Non-acute trauma
• Admitted with primary burn injury
• Expired prior to admission
• Moribund
• Discharge from emergency department
• Left against medical advice

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

484 participants in 2 patient groups

Standard of Care

Active Comparator group

Treatment:

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

Standard of Care + Dronabinol

Experimental group

Treatment:

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

Drug: Dronabinol