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OpenTrials
Completed

NCT Number: NCT02814305

Opioid Analgesic Use and Disposal Following Outpatient Dental Surgery

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Financial

Behavioral

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

Educational

Behavioral

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

Primary outcomes

  1. Unused opioids

    Time frame: 21 days after surgery

    Number of opioids reported unused by the patient after postoperative day 21

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Important dates

Study start
2015
Primary completion
2015
First posted
Jun 27, 2016
Registry last updated
Jun 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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