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

Pain Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03529331
• Other study ID #: 2018-03-01
• Status: Withdrawn
• Phase: Phase 4
• Start date: September 1, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: April 2019
• Source: Maimonides Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Morphine Sulfate Immediate Release
15 mg Morphine Sulfate Immediate Release (MSIR) tablet 4 times a day for 5 days
• Oxycodone/Acetaminophen
5 mg of Oxycodone/Acetaminophen (Percocet) tablet 4 times a day for 5 days
• Hydrocodone/Acetaminophen
5 mg of Hydrocodone/Acetaminophen (Vicodin) tablet 4 times a day for 5 days

Locations

Country	Name	City	State
United States	Maimonides Medical Center	Brooklyn	New York

Sponsors (1)

Lead Sponsor	Collaborator
Antonios Likourezos

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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