Opioid Analgesic Use and Disposal Following Outpatient Dental Surgery

NCT02814305 | Completed

• 1 other identifier: 821823
• Study Type: interventional
• Target: 79
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Opioid Use Disorders; Tooth Extraction Status Nos

Outcome Measures

Primary Outcomes (1)

• Unused opioids

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

  21 days after surgery

Secondary Outcomes (1)

• 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

Study Arms (4)

Control

NO INTERVENTION

Patient receives neither educational nor financial interventions

Financial intervention only

EXPERIMENTAL

Patient receives financial (pharmacy offer) intervention only

Behavioral: Financial

Educational intervention only

EXPERIMENTAL

Patient receives educational (narrative) intervention only

Behavioral: Educational

Both interventions

EXPERIMENTAL

Patient receives both educational and financial interventions

Behavioral: Financial; Behavioral: Educational

Interventions

Financial BEHAVIORAL

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

Both interventions; Financial intervention only

Educational BEHAVIORAL

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

Both interventions; Educational intervention only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-institutionalized

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2016
• First Posted: June 27, 2016
• Study Start: March 1, 2015
• Primary Completion: September 1, 2015
• Last Updated: June 27, 2016

Record last verified: 2016-06