Opioid Analgesic Use and Disposal Following Outpatient Dental Surgery

Tooth Extraction Status Nos Clinical Trial

Official title:

Opioid Analgesic Use and Disposal Following Outpatient Dental Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02814305
• Other study ID #: 821823
• Status: Completed
• Phase: N/A
• First received: June 16, 2016
• Last updated: June 22, 2016
• Start date: March 2015

Study information

• Verified date: June 2016
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Opioid Use Disorders
• Tooth Extraction Status Nos

Intervention

Behavioral:
• Financial
Patient receives information on a program that may offer a financial benefit for disposing of unused opioid analgesics at a pharmacy
• Educational
Patient watches a video featuring narrative vignettes of patients who developed opioid dependence or abuse after using opioids postoperatively

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Unused opioids	Number of opioids reported unused by the patient after postoperative day 21	21 days after surgery	No
Secondary	Intent to dispose of opioids	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	No