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

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ClinicalTrials.gov Identifier: NCT03529331

Recruitment Status : Withdrawn (The ED physicians no longer prescribe opioids at discharge; not feasible to conduct the study)

First Posted : May 18, 2018

Last Update Posted : April 23, 2019

Sponsor:

Information provided by (Responsible Party):

Antonios Likourezos, Maimonides Medical Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pain	Drug: Morphine Sulfate Immediate Release Drug: Oxycodone/Acetaminophen Drug: Hydrocodone/Acetaminophen	Phase 4

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	0 participants
Allocation:	Randomized
Intervention Model:	Sequential Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
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.
Estimated Study Start Date :	September 1, 2019
Estimated Primary Completion Date :	December 31, 2021
Estimated Study Completion Date :	December 31, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Morphine sulfate Oxycodone Acetaminophen Oxycodone hydrochloride Hydrocodone Hydrocodone bitartrate Hycodan Sulfate ion

U.S. FDA Resources

Arms and Interventions

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 Name: 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 Name: Vicodin

Outcome Measures

Primary Outcome Measures :

Percentage of Patients using Prescribed Medication at 1 month [ Time Frame: 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 :

Percentage of Patients Using Prescribed Medication at 3 months [ Time Frame: 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.

Other Outcome Measures:

Percentage of Patients Using Prescribed Medication at 6 months [ Time Frame: 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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 120 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03529331

Locations

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

Sponsors and Collaborators

Antonios Likourezos

Investigators

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Principal Investigator:	Sergey Motov, MD	Maimonides Medical Center

More Information

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Responsible Party:	Antonios Likourezos, Research Manager, Maimonides Medical Center
ClinicalTrials.gov Identifier:	NCT03529331
Other Study ID Numbers:	2018-03-01
First Posted:	May 18, 2018 Key Record Dates
Last Update Posted:	April 23, 2019
Last Verified:	April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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Studies a U.S. FDA-regulated Drug Product:	Yes
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Antonios Likourezos, Maimonides Medical Center:


Pain Medications, Analgesia, Emergency Medicine

Additional relevant MeSH terms:

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Acetaminophen Acetaminophen, hydrocodone drug combination Morphine Oxycodone Hydrocodone Analgesics, Opioid Narcotics Central Nervous System Depressants Physiological Effects of Drugs Analgesics	Sensory System Agents Peripheral Nervous System Agents Analgesics, Non-Narcotic Antipyretics Antitussive Agents Respiratory System Agents Anti-Inflammatory Agents, Non-Steroidal Anti-Inflammatory Agents Antirheumatic Agents

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