Status:
ACTIVE_NOT_RECRUITING
Opioid Analgesic Reduction Study
Lead Sponsor:
Rutgers, The State University of New Jersey
Collaborating Sponsors:
National Institute of Dental and Craniofacial Research (NIDCR)
University of Rochester
Conditions:
Opioid Use
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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...
Eligibility Criteria
Inclusion
- An individual must meet all of the following criteria to be eligible to participate in the study:
- Be able to understand the informed consent.
- Provide signed and dated informed consent form
- Be able to understand all directions for data gathering instruments in English
- Be willing and able to comply with all study procedures and be available for the duration of the study
- Planning to undergo extraction of one or more partial or fully impacted mandibular 3rd molars
- Be 18 years or older
- Be in good general health as evidenced by medical history
- Women must agree to use one of the following methods of contraception while participating in this study:
- contraceptive pill
- intra-uterine device
- condoms
- abstinence
Exclusion
- Participants who self-report the following history will be excluded from participating:
- History of gastrointestinal bleeding and/or peptic ulcer
- History of renal disease (excluding kidney stones)
- History of hepatic disease
- History of bleeding disorder
- History of respiratory depression
- Any prior respiratory effect of an opioid or other anesthetic drugs that required respiratory support postoperatively
- Active or untreated asthma
- History of known allegoric reaction to ibuprofen, acetaminophen, hydrocodone, and/or anesthesia
- Currently taking any of the following medications:
- CYP3A4 inhibitor, such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), and protease inhibitors (e.g., ritonavir), which may increase plasma concentrations of hydrocodone bitartrate and acetaminophen and prolong opioid adverse reactions, and which may cause potentially fatal respiratory depression
- CNS depressants.
- Consumes 3 or more alcoholic drinks every day and/or has a history of alcoholism
- History of drug or alcohol abuse
- Family history of drug or alcohol abuse in a first-degree relative
- Has had no more than one opioid prescription filled within the past 12 months
- Currently pregnant or lactating
- Participants would also be excluded due to any additional criteria that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study which includes:
- Prior participation in this study
- Inability or refusal to provide informed consent
Key Trial Info
Start Date :
January 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2025
Estimated Enrollment :
1815 Patients enrolled
Trial Details
Trial ID
NCT04452344
Start Date
January 4 2021
End Date
December 31 2025
Last Update
December 11 2025
Active Locations (5)
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1
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
2
University of Maryland
Baltimore, Maryland, United States, 21201
3
University of Michigan
Ann Arbor, Michigan, United States, 48109
4
Rutgers School of Dental Medicine
Newark, New Jersey, United States, 07101