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

A Study Comparing Recurrent Use of Morphine Sulfate Immediate Release, Oxycodone/Acetaminophen (Percocet), and Hydrocodone/Acetaminophen (Vicodin) at Discharge From the ED in Opioid-naïve Adult Patients With Moderate to Severe Pain.

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.

Study Overview

• Status: Withdrawn
• Conditions: Pain
• Intervention / Treatment: Drug: Morphine Sulfate Immediate Release; Drug: Oxycodone/Acetaminophen; Drug: Hydrocodone/Acetaminophen

Detailed Description

Purpose:

The purpose of this study is to evaluate and compare rates of recurrent use (surrogate for abuse liability and likeability) of Morphine Sulfate Immediate Release, Oxycodone/Acetaminophen (Percocet), and Hydrocodone/Acetaminophen (Vicodin) at discharge from the ED (by comparing a percentage of patients in each group at 1 month, 3 months and 6 months that are still using the same opioid analgesics for presumably non-medical use.

Objective and Hypothesis:

The outcome of the study is to evaluate and compare the rates of recurrent use of prescribed opioids at discharge from the ED by comparing a percentage of patients in each group at 1 month, 3 months and 6 months that are still using the same opioid analgesics for presumably non-medical use that will be used as a surrogate for comparison of abuse liability and likeability. Our goal is to prove that MSIR will have the lowest recurrent use rates at specified time periods than Percocet and Vicodin and that MSIR should be considered as the opioid of choice at discharge from the ED. Our hypothesis is that MSIR is associated with lower number of patients with recurrent use at specified time periods than Percocet and Vicodin due to the lesser abuse liability and likeability.

Methodology:

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 ED 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.

Statistical Analyses:

The nominal variables will be presented as percentages with confidence intervals (CIs), and continuous variables will be presented as means with SDs, or medians with interquartile ranges when appropriate. The odds ratios of recurrent use will be compared with logistic regression to adjust for age, sex, race, chief complaint, and opioid prescription filling. In addition, to test for proportional difference with respect to recurrent opioid use, we will use a Pearson Chi-square test.

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • Brooklyn, New York, United States, 11219
      • Maimonides Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 116 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• ED patient
• 18 and older
• acute to moderate to severe pain
• requires oral opioid medications at ED discharge.

Exclusion Criteria:

• chronic non-cancer and cancer pain,
• patients with history of substance abuse
• patients with opioid use disorder,
• patients simultaneously taking antidepressants, benzodiazepines and other sedative-hypnotics,
• and allergies to any of the medications.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Morphine Sulfate Immediate Release; ED patients at discharge will receive 15 mg Morphine Sulfate Immediate Release (MSIR) tablet 4 times a day for 5 days.	Drug: Morphine Sulfate Immediate Release; 15 mg Morphine Sulfate Immediate Release (MSIR) tablet 4 times a day for 5 days
Active Comparator: Oxycodone/Acetaminophen (Percocet),; ED patients at discharge will receive 5 mg of Oxycodone/Acetaminophen (Percocet) 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; Other Names: Percocet
Active Comparator: Hydrocodone/Acetaminophen (Vicodin); ED patients at discharge will receive 5 mg of Hydrocodone/Acetaminophen (Vicodin) 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; Other Names: Vicodin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Patients using Prescribed Medication at 1 month	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.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Patients Using Prescribed Medication at 3 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.	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Patients Using Prescribed Medication at 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.	6 months

Collaborators and Investigators

• Sponsor: Antonios Likourezos

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2019
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: May 7, 2018
• First Submitted That Met QC Criteria: May 7, 2018
• First Posted (Actual): May 18, 2018

Study Record Updates

• Last Update Posted (Actual): April 23, 2019
• Last Update Submitted That Met QC Criteria: April 19, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Pain Medications, Analgesia, Emergency Medicine
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antipyretics; Analgesics, Opioid; Narcotics; Respiratory System Agents; Antitussive Agents; Acetaminophen; Morphine; Oxycodone; Hydrocodone; Acetaminophen, hydrocodone drug combination
• Other Study ID Numbers: 2018-03-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No