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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up recorded during visit 2 (post operative visit 9 days +/-5 days post surgery)
Awards & highlights
OARS 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.Check my eligibility
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.See study design
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.
OARS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am planning to have my wisdom teeth removed.
Select...
I am 18 years old or older.
Select...
I agree to use birth control methods like pills, IUDs, condoms, or abstinence.
OARS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ recorded during visit 2 (post operative visit 9 days +/-5 days post surgery)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~recorded during visit 2 (post operative visit 9 days +/-5 days post surgery)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Brief Pain Inventory pain scale using Numeric Rating Scale
PTSS satisfaction questions assessing overall satisfaction
Secondary outcome measures
Adverse events experienced
Overall satisfaction with sleep
Pain interference (daily function)
+4 moreOARS 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
609 Previous Clinical Trials
1,557,509 Total Patients Enrolled
University of MichiganOTHER
1,797 Previous Clinical Trials
6,376,258 Total Patients Enrolled
Rutgers, The State University of New JerseyLead Sponsor
429 Previous Clinical Trials
62,432 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am planning to have my wisdom teeth removed.You are using an intrauterine device (IUD) for birth control.I am currently using contraceptive pills.I am 18 years old or older.I have a history of bleeding disorders.I have a history of kidney disease, not including kidney stones.I have a history of liver disease.I am willing and able to follow the study's requirements for its entire duration.I agree to use birth control methods like pills, IUDs, condoms, or abstinence.I have had episodes where my breathing was dangerously slow or stopped.I have had stomach ulcers or bleeding in my digestive tract.I needed help breathing after surgery due to a reaction to pain or anesthesia medication.I have asthma that is currently active or untreated.You have had a previous allergic reaction to ibuprofen, acetaminophen, hydrocodone, or anesthesia.
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Opioid
- Group 2: Non-Opioid
Opioid Use Disorder Patient Testimony for trial: Trial Name: NCT04452344 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
If this research project is successful, how many different places could it be implemented?
"At the moment, this experiment is taking place at 5 different hospitals. The sites are situated in Rochester, Baltimore, Chicago and 2 other cities. If you want to cut down on travel, it would be best to select the location nearest to you."
Answered by AI
Could you explain the potential risks associated with Non-Opioid treatments?
"There is already some evidence to support the efficacy of Non-Opioid medication, as this is a Phase 3 trial. Furthermore, multiple rounds of data have also been collected to support its safety, so it received a score of 3."
Answered by AI
Who else is applying?
What state do they live in?
Illinois
Michigan
Other
Maryland
How old are they?
65+
What site did they apply to?
University of Illinois at Chicago
University of Maryland
University of Michigan
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
3+
Why did patients apply to this trial?
I've been living with this addiction for over 5 years and I really want to quit using without the complications of withdrawal, please give me a chance at becoming clean.
PatientReceived 2+ prior treatments
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