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A Study Comparing Recurrent Use of MSIR, Percocet, and Vicodin at Discharge From the ED

NCT03529331 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2019-04-23

No results posted yet for this study

Summary

This is a prospective randomized, clinical trial comparing recurrent use of Morphine Sulfate Immediate Release (MSIR), Oxycodone/Acetaminophen (Percocet), and Hydrocodone/Acetaminophen (Vicodin) at discharge from the emergency department for opioid-naive adult patients presenting with moderate-to-severe pain. At discharge, patients will be randomized to receive either 5 mg of Oxycodone/Acetaminophen (Percocet) tablet 4 times a day for 5 days, 5 mg of Hydrocodone/Acetaminophen (Vicodin) tablet 4 times a day for 5 days, or 15 mg Morphine Sulfate Immediate Release (MSIR) tablet 4 times a day for 5 days. At 1 month, 3 months, and 6 months patients' prescription's history will be accessed by using the DoctorFirst Drug Database to determine the recurrent use that will serve as a surrogate marker of likeability and abuse liability of each prescribed opioid.

Conditions

Interventions

DRUG

Morphine Sulfate Immediate Release

15 mg Morphine Sulfate Immediate Release (MSIR) tablet 4 times a day for 5 days

DRUG

Oxycodone/Acetaminophen

5 mg of Oxycodone/Acetaminophen (Percocet) tablet 4 times a day for 5 days

DRUG

Hydrocodone/Acetaminophen

5 mg of Hydrocodone/Acetaminophen (Vicodin) tablet 4 times a day for 5 days

Sponsors & Collaborators

  • Antonios Likourezos

    lead OTHER

Principal Investigators

  • Sergey Motov, MD · Maimonides Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2021-12-31
Completion
2021-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT03529331 on ClinicalTrials.gov