Methods for Effective Disposal of Surplus Analgesics to Facilitate Elimination

Surgery Clinical Trial

— MEDSAFE  

Official title:

Methods for Effective Disposal of Surplus Analgesics to Facilitate Elimination

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05991687
• Other study ID #: HUM00236974
• Secondary ID: E20233700-001
• Status: Recruiting
• Phase: N/A
• Start date: July 31, 2023
• Est. completion date: November 2024

Study information

• Verified date: February 2024
• Source: University of Michigan
• Contact: Heather Lipkovitch
• Phone: 734-936-4280
• Email: hlipkovi[@]umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective is to evaluate the difference in outcomes for mail-in vs. in-home disposal methods for leftover prescription opioids after discharge from surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Anticipated to be prescribed and use an opioid medication to treat acute pain after elective outpatient surgery

• Opioid-naive

Exclusion Criteria:

• Inability to receive email and/or phone calls for follow up assessment

Related Conditions & MeSH terms

• Surgery

Intervention

Other:
• In-home drug disposal pouch
Will receive a drug disposal pouch to inactivate leftover prescription opioids for disposal after surgery.
• Mail-in prepaid envelope
Will receive a prepaid envelope to mail leftover prescription opioids for disposal after surgery

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Michigan Department of Health and Human Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Use of assigned disposal method	Among patients who have leftover opioids, patient report of the use of their assigned mail-in or in-home method of disposal by 2 weeks after surgery.	2 weeks after surgery
Secondary	Use of safe disposal method	Patient-reported use of a method for disposal of leftover opioids that includes mail-in, in-home, pharmacy drop off, or flushing down the toilet by	2 weeks after surgery
Secondary	Use of any disposal method	Patient-reported use of any method to dispose of leftover opioids, that includes assigned methods, safe methods, and other methods such as placing in the trash	2 weeks after surgery
Secondary	Feasibility of Intervention Measure (FIM)		2 weeks after surgery
Secondary	Acceptability of Intervention Measure (AIM)		2 weeks after surgery
Secondary	Patient-Reported Satisfaction with Use of Disposal Method (study derived question)	Patient report of overall satisfaction with use of the assigned disposal method, on a 0 (worst) to 10 (best) numeric scale	2 weeks after surgery