Opioid Analgesic Use and Disposal Following Outpatient Dental Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Opioid Use Disorders Tooth Extraction Status Nos

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Control

Patient receives neither educational nor financial interventions

Group Type NO_INTERVENTION

No interventions assigned to this group

Financial intervention only

Patient receives financial (pharmacy offer) intervention only

Group Type EXPERIMENTAL

Financial

Intervention Type BEHAVIORAL

Patient receives information on a program that may offer a financial benefit for disposing of unused opioid analgesics at a pharmacy

Educational intervention only

Patient receives educational (narrative) intervention only

Group Type EXPERIMENTAL

Educational

Intervention Type BEHAVIORAL

Patient watches a video featuring narrative vignettes of patients who developed opioid dependence or abuse after using opioids postoperatively

Both interventions

Patient receives both educational and financial interventions

Group Type EXPERIMENTAL

Financial

Intervention Type BEHAVIORAL

Patient receives information on a program that may offer a financial benefit for disposing of unused opioid analgesics at a pharmacy

Educational

Intervention Type BEHAVIORAL

Patient watches a video featuring narrative vignettes of patients who developed opioid dependence or abuse after using opioids postoperatively

Interventions

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Financial

Patient receives information on a program that may offer a financial benefit for disposing of unused opioid analgesics at a pharmacy

Intervention Type BEHAVIORAL

Educational

Patient watches a video featuring narrative vignettes of patients who developed opioid dependence or abuse after using opioids postoperatively

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes