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Opioid Analgesics

Non-Opioid Pain Relievers for Opioid Use Disorder (OARS Trial)

Phase 3
Waitlist Available
Led By Cecile A Feldman, DMD
Research Sponsored by Rutgers, The State University of New Jersey
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Planning to undergo extraction of one or more partial or fully impacted mandibular 3rd molars
Be 18 years or older
Must not have
History of bleeding disorder
History of renal disease (excluding kidney stones)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up when first waking up the day after surgery
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial will test the hypothesis that a combination of over-the-counter non-opioid containing analgesics is at least as, if not more, effective (non-inferior) than the most commonly prescribed opioid analgesic.

Who is the study for?
Adults over 18, in good health, needing wisdom tooth removal can join this trial. They must understand English and consent to the study's procedures. Women should use contraception like pills or IUDs. Those with asthma, allergies to pain meds, heavy alcohol use, drug abuse history or taking certain medications cannot participate.
What is being tested?
The study is testing if a mix of two non-opioid painkillers works as well as an opioid-based one for managing post-wisdom tooth extraction pain. Participants will be randomly assigned to receive either the non-opioid combination or the standard opioid analgesic without knowing which one they're getting.
What are the potential side effects?
Possible side effects may include allergic reactions to the analgesics used (ibuprofen and acetaminophen), gastrointestinal issues such as bleeding or ulcers from ibuprofen, liver damage from acetaminophen overdose, and respiratory depression from opioids.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am planning to have my wisdom teeth removed.
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I am 18 years old or older.
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I agree to use birth control methods like pills, IUDs, condoms, or abstinence.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of bleeding disorders.
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I have a history of kidney disease, not including kidney stones.
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I have had episodes where my breathing was dangerously slow or stopped.
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I have had stomach ulcers or bleeding in my digestive tract.
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I needed help breathing after surgery due to a reaction to pain or anesthesia medication.
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I have asthma that is currently active or untreated.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at time of post-operative visit (day 9 +/- 5 days)
This trial's timeline: 3 weeks for screening, Varies for treatment, and at time of post-operative visit (day 9 +/- 5 days) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Composite Pain 1
Composite Pain 2
Composite Pain 3
+10 more
Secondary study objectives
Number of Participants Receiving Rescue Medication
Pain Interference 1
Pain Interference 2
+7 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Active Control
Group I: OpioidActive Control1 Intervention
Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill.
Group II: Non-OpioidActive Control1 Intervention
Combination of ibuprofen 400 mg/acetaminophen 500 mg

Find a Location

Who is running the clinical trial?

University of Illinois at ChicagoOTHER
639 Previous Clinical Trials
1,567,289 Total Patients Enrolled
University of MichiganOTHER
1,857 Previous Clinical Trials
6,435,869 Total Patients Enrolled
Rutgers, The State University of New JerseyLead Sponsor
450 Previous Clinical Trials
63,897 Total Patients Enrolled

Media Library

Opioid-containing Analgesic (Opioid Analgesics) Clinical Trial Eligibility Overview. Trial Name: NCT04452344 — Phase 3
Opioid Use Disorder Clinical Trial 2023: Opioid-containing Analgesic Highlights & Side Effects. Trial Name: NCT04452344 — Phase 3
Opioid-containing Analgesic (Opioid Analgesics) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04452344 — Phase 3
Opioid Use Disorder Research Study Groups: Opioid, Non-Opioid
Opioid Use Disorder Patient Testimony for trial: Trial Name: NCT04452344 — Phase 3
~376 spots leftby Nov 2025
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