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

Recruiting in Palo Alto (17 mi)

+4 other locations

Overseen byCecile A Feldman, DMD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Rutgers, The State University of New Jersey

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?The goal is to provide health care professionals, including dentists, with the best possible evidence for clinical decision making when deciding upon analgesics for acute post-surgical pain management, a double-blind, stratified randomized clinical trial will be conducted to 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. The impacted 3rd molar extraction model will be used due to the predictable severity of the post-operative pain and generalizability of results. This double-blind, prospective, stratified, randomized pragmatic clinical trial will use the impacted 3rd molar extraction pain model.

Eligibility Criteria

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.

Inclusion 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.

+7 more

Exclusion Criteria

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.

+7 more

Participant Groups

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.

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