Opioid Analgesic Use and Disposal Following Outpatient Dental Surgery
Primary Purpose
Opioid Use Disorders, Tooth Extraction Status Nos
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Financial
Educational
Sponsored by
About this trial
This is an interventional health services research trial for Opioid Use Disorders
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
No Intervention
Experimental
Experimental
Experimental
Arm Label
Control
Financial intervention only
Educational intervention only
Both interventions
Arm Description
Patient receives neither educational nor financial interventions
Patient receives financial (pharmacy offer) intervention only
Patient receives educational (narrative) intervention only
Patient receives both educational and financial interventions
Outcomes
Primary Outcome Measures
Unused opioids
Number of opioids reported unused by the patient after postoperative day 21
Secondary Outcome Measures
Intent to dispose of opioids
Patient reports intent to dispose of leftover opioids during follow-up interview or by calling study hotline
Full Information
NCT ID
NCT02814305
First Posted
June 16, 2016
Last Updated
June 22, 2016
Sponsor
University of Pennsylvania
1. Study Identification
Unique Protocol Identification Number
NCT02814305
Brief Title
Opioid Analgesic Use and Disposal Following Outpatient Dental Surgery
Official Title
Opioid Analgesic Use and Disposal Following Outpatient Dental Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use Disorders, Tooth Extraction Status Nos
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
79 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patient receives neither educational nor financial interventions
Arm Title
Financial intervention only
Arm Type
Experimental
Arm Description
Patient receives financial (pharmacy offer) intervention only
Arm Title
Educational intervention only
Arm Type
Experimental
Arm Description
Patient receives educational (narrative) intervention only
Arm Title
Both interventions
Arm Type
Experimental
Arm Description
Patient receives both educational and financial interventions
Intervention Type
Behavioral
Intervention Name(s)
Financial
Intervention Description
Patient receives information on a program that may offer a financial benefit for disposing of unused opioid analgesics at a pharmacy
Intervention Type
Behavioral
Intervention Name(s)
Educational
Intervention Description
Patient watches a video featuring narrative vignettes of patients who developed opioid dependence or abuse after using opioids postoperatively
Primary Outcome Measure Information:
Title
Unused opioids
Description
Number of opioids reported unused by the patient after postoperative day 21
Time Frame
21 days after surgery
Secondary Outcome Measure Information:
Title
Intent to dispose of opioids
Description
Patient reports intent to dispose of leftover opioids during follow-up interview or by calling study hotline
Time Frame
Any time during the 21-day data collection period or during the follow-up interview on (or shortly after) postoperative day 21
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
12. IPD Sharing Statement
Learn more about this trial
Opioid Analgesic Use and Disposal Following Outpatient Dental Surgery
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