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Behavioral Intervention

Intervention condition for Acetaminophen (ADOPT Trial)

N/A

Waitlist Available

Led By Douglas R Oyler, PharmD

Research Sponsored by Douglas Oyler

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient must be aged 12-25 at the time of tooth extraction

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up same calendar date as dental extraction. electronic health records will be extracted for the duration of the 4-year study period.

Awards & highlights

ADOPT Trial Summary

"This trial aims to test a new intervention for oral surgeons who remove teeth to see if it can reduce opioid prescriptions to adolescents and young adults after the procedure. The study will also evaluate if the intervention changes

Who is the study for?

This trial is for adolescents and young adults who are having teeth removed. Oral surgeons participating will need to attend an educational session, provide specific pain medications, and complete surveys. Patients must take a survey about their pain and medication use post-extraction.Check my eligibility

What is being tested?

The study tests if a three-part intervention can cut down opioid prescriptions after tooth removal compared to usual care. It includes education for oral surgeons, special patient instructions, and blister packs of non-opioid pain medicine.See study design

What are the potential side effects?

Since the focus is on reducing opioid use by providing alternatives like acetaminophen or ibuprofen, side effects may include typical reactions to these drugs such as stomach upset or mild allergic responses.

ADOPT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 12 and 25 years old.

ADOPT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ same calendar date as dental extraction. electronic health records will be extracted for the duration of the 4-year study period.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~same calendar date as dental extraction. electronic health records will be extracted for the duration of the 4-year study period.

This trial's timeline: 3 weeks for screening, Varies for treatment, and same calendar date as dental extraction. electronic health records will be extracted for the duration of the 4-year study period. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Odds of post-extraction opioid prescription to adolescent/young adults after tooth extraction

Secondary outcome measures

(Change in) intervention appropriateness

(Change in) intervention feasibility

(Change in) opioid prescribing appropriateness

+4 more

ADOPT Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention conditionExperimental Treatment1 Intervention

Academic detailing (45 to 60-minute session), plus Provision of standardized patient post-extraction instructions for distribution, plus Provision of blister-packaged acetaminophen and ibuprofen at recommended standard doses for distribution to to adolescent/young adult patients after tooth extraction in the course of clinical practice

Group II: Control conditionActive Control1 Intervention

Usual practice

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Multicomponent intervention

2014

Completed Phase 3

~7990

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Douglas OylerLead Sponsor

National Institute of Dental and Craniofacial Research (NIDCR)NIH

300 Previous Clinical Trials

810,453 Total Patients Enrolled

Douglas R Oyler, PharmDPrincipal InvestigatorUniversity of Kentucky

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Which individuals are eligible to take part in this research investigation?

"To qualify for inclusion in this research study, individuals must present with acute pain and fall within the age range of 12 to 25 years. The trial has an anticipated enrollment capacity of approximately 38,159 participants."

Answered by AI

Is the recruitment phase currently open for this clinical trial?

"According to clinicaltrials.gov, patient recruitment for this research is not ongoing. The trial was initially listed on April 1st, 2024, and the latest update was made on February 16th, 2024. Despite this specific study being inactive in terms of patient enrollment, there are currently 186 other trials actively seeking participants."

Answered by AI

Is there an age limit for enrollment in this research study, specifically excluding individuals over 75 years old?

"Prospective participants must be between the ages of 12 and 25 to meet the age requirements outlined in this study's eligibility criteria."

Answered by AI

Am I eligible to participate in this clinical investigation?

"To be eligible for participation in this medical research, individuals must experience sudden onset of pain and fall between the ages of 12 to 25. A total of 38159 participants will be accepted into the study."

Answered by AI

Are there any available vacancies for participants in this clinical trial?

"According to information on clinicaltrials.gov, recruitment for this particular trial has concluded. While the study was initially listed on April 1st, 2024 and last updated on February 16th, 2024, it is important to note that there are currently 186 alternative trials actively seeking participants."

Answered by AI

Is the clinical trial open to participants who are below 25 years old?

"Participants eligible for enrollment in this research endeavor must fall within the age range of 12 to 25 years. Among the various clinical studies, there are specifically 53 investigations tailored towards individuals under 18 years old and an additional 132 trials designated for those over 65 years of age."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Alternatives to Dental Opioid Prescribing After Tooth Extraction

Douglas Oyler 2024. "Alternatives to Dental Opioid Prescribing After Tooth Extraction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06275191.

All > Acute Pain