NCT03529331

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2019

Typical duration for phase_4 pain

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 7, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 18, 2018

Completed
1.3 years until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

April 23, 2019

Status Verified

April 1, 2019

Enrollment Period

2.3 years

First QC Date

May 7, 2018

Last Update Submit

April 19, 2019

Conditions

Pain

Keywords

Pain Medications, Analgesia, Emergency Medicine

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Percentage of Patients Using Prescribed Medication at 3 months

    3 months

Other Outcomes (1)

  • Percentage of Patients Using Prescribed Medication at 6 months

    6 months

Study Arms (3)

Morphine Sulfate Immediate Release

ACTIVE COMPARATOR

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

Oxycodone/Acetaminophen (Percocet),

ACTIVE COMPARATOR

ED patients at discharge will receive 5 mg of Oxycodone/Acetaminophen (Percocet) tablet 4 times a day for 5 days.

Drug: Oxycodone/Acetaminophen

Hydrocodone/Acetaminophen (Vicodin)

ACTIVE COMPARATOR

ED patients at discharge will receive 5 mg of Hydrocodone/Acetaminophen (Vicodin) tablet 4 times a day for 5 days.

Drug: Hydrocodone/Acetaminophen

Interventions

Morphine Sulfate Immediate ReleaseDRUG

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

Morphine Sulfate Immediate Release
Oxycodone/AcetaminophenDRUG

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

Also known as: Percocet
Oxycodone/Acetaminophen (Percocet),
Hydrocodone/AcetaminophenDRUG

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

Also known as: Vicodin
Hydrocodone/Acetaminophen (Vicodin)

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

MeSH Terms

Conditions

PainAgnosia

Interventions

Morphineoxycodone-acetaminophenacetaminophen, hydrocodone drug combination

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Intervention Hierarchy (Ancestors)

Morphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Sergey Motov, MD

    Maimonides Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Manager

Study Record Dates

First Submitted

May 7, 2018

First Posted

May 18, 2018

Study Start

September 1, 2019

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

April 23, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)