Opioid Analgesic Use and Disposal Following Outpatient Dental Surgery

Not Applicable

Completed

• Conditions: Opioid Use Disorders; Tooth Extraction Status Nos
• Interventions: Behavioral: Financial; Behavioral: Educational

• Registration Number: NCT02814305
• Lead Sponsor: University of Pennsylvania

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03
• Primary Completion: 2015-09
• Status Verified: 2016-06
• Study First Submitted: 2016-06-16
• Study First Submitted QC: 2016-06-22
• Last Update Submitted: 2016-06-22
• Study First Posted: 2016-06-27
• Last Update Posted: 2016-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

Inclusion Criteria

• Non-institutionalized

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Both interventions	Educational	Patient receives both educational and financial interventions
Financial intervention only	Financial	Patient receives financial (pharmacy offer) intervention only
Both interventions	Financial	Patient receives both educational and financial interventions
Educational intervention only	Educational	Patient receives educational (narrative) intervention only

Primary Outcome Measures

Name	Time	Method
Unused opioids	21 days after surgery	Number of opioids reported unused by the patient after postoperative day 21

Secondary Outcome Measures

Name	Time	Method
Intent to dispose of opioids	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