Opioid Analgesic Use and Disposal Following Outpatient Dental Surgery

June 22, 2016 updated by: University of Pennsylvania

Background: Overdose deaths from prescription opioid analgesics quadrupled from 4,000 cases to nearly 17,000 cases annually during 1999-2011. Most people who misuse or abuse prescription opioids obtain these pills from friends or family members who have surplus medication left over from prior prescriptions. There is little published data on surplus opioid analgesics remaining after patients recover from painful procedures. Even less is known about patients' willingness to dispose of these leftover pills.

Aims: 1) Measure the impact of a risk education intervention and a financial incentive intervention on patients' willingness to dispose of surplus opioids left over after outpatient dental surgery. 2) Measure the number and proportion of opioid pills left unused after outpatient dental surgery.

Methods: The study will be a pilot randomized controlled trial. Adult patients at the Penn Dental Care Center will be enrolled prior to elective outpatient dental surgery. Patients will be randomized to a control group, an educational intervention, or a financial incentive intervention. The primary outcome of the trial is the proportion of patients in each arm that express willingness to return their unused opioids. Secondary outcomes include patient use of prescribed opioids and their number of unused pills. These outcomes will be measured using novel text-message based data collection software that patients will interact with using a web-enabled cellular telephone or tablet.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

79

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Non-institutionalized

Exclusion Criteria:

  • pregnancy
  • a history of opioid analgesic misuse/abuse
  • ongoing participation in other clinical research
  • or daily use of opioid analgesics in the week prior to surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Patient receives neither educational nor financial interventions
Experimental: Financial intervention only
Patient receives financial (pharmacy offer) intervention only
Behavioral: Financial
Patient receives information on a program that may offer a financial benefit for disposing of unused opioid analgesics at a pharmacy
Experimental: Educational intervention only
Patient receives educational (narrative) intervention only
Behavioral: Educational
Patient watches a video featuring narrative vignettes of patients who developed opioid dependence or abuse after using opioids postoperatively
Experimental: Both interventions
Patient receives both educational and financial interventions
Behavioral: Financial
Patient receives information on a program that may offer a financial benefit for disposing of unused opioid analgesics at a pharmacy
Behavioral: Educational
Patient watches a video featuring narrative vignettes of patients who developed opioid dependence or abuse after using opioids postoperatively

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Unused opioids
Time Frame: 21 days after surgery
Number of opioids reported unused by the patient after postoperative day 21
21 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intent to dispose of opioids
Time Frame: Any time during the 21-day data collection period or during the follow-up interview on (or shortly after) postoperative day 21
Patient reports intent to dispose of leftover opioids during follow-up interview or by calling study hotline
Any time during the 21-day data collection period or during the follow-up interview on (or shortly after) postoperative day 21

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

June 16, 2016

First Submitted That Met QC Criteria

June 22, 2016

First Posted (Estimate)

June 27, 2016

Study Record Updates

Last Update Posted (Estimate)

June 27, 2016

Last Update Submitted That Met QC Criteria

June 22, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 821823

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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