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

Phase 4

Withdrawn

• Conditions: Pain
• Interventions: Drug: Morphine Sulfate Immediate Release; Drug: Oxycodone/Acetaminophen; Drug: Hydrocodone/Acetaminophen

• Registration Number: NCT03529331
• Lead Sponsor: Antonios Likourezos

Brief 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.

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 Timeline

• Study First Submitted: 2018-05-07
• Study First Submitted QC: 2018-05-07
• Study First Posted: 2018-05-18
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-19
• Last Update Posted: 2019-04-23
• Study Start: 2019-09-01
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Morphine Sulfate Immediate Release	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.
Oxycodone/Acetaminophen (Percocet),	Oxycodone/Acetaminophen	ED patients at discharge will receive 5 mg of Oxycodone/Acetaminophen (Percocet) tablet 4 times a day for 5 days.
Hydrocodone/Acetaminophen (Vicodin)	Hydrocodone/Acetaminophen	ED patients at discharge will receive 5 mg of Hydrocodone/Acetaminophen (Vicodin) tablet 4 times a day for 5 days.

Primary Outcome Measures

Name	Time	Method
Percentage of Patients using Prescribed Medication at 1 month	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Patients Using Prescribed Medication at 3 months	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.

Trial Locations

Locations (1)

Maimonides Medical Center; 🇺🇸 Brooklyn, New York, United States