Methods for Effective Disposal of Surplus Analgesics to Facilitate Elimination (MEDSAFE)

February 6, 2024 updated by: Mark Bicket, MD, PhD, University of Michigan
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: In-home
Other: In-home drug disposal pouch
Will receive a drug disposal pouch to inactivate leftover prescription opioids for disposal after surgery.
Active Comparator: Mail-in
Other: Mail-in prepaid envelope
Will receive a prepaid envelope to mail leftover prescription opioids for disposal after surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Use of assigned disposal method
Time Frame: 2 weeks after surgery
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Use of safe disposal method
Time Frame: 2 weeks after surgery
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
Use of any disposal method
Time Frame: 2 weeks after surgery
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
Feasibility of Intervention Measure (FIM)
Time Frame: 2 weeks after surgery
2 weeks after surgery
Acceptability of Intervention Measure (AIM)
Time Frame: 2 weeks after surgery
2 weeks after surgery
Patient-Reported Satisfaction with Use of Disposal Method (study derived question)
Time Frame: 2 weeks after surgery
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Collaborators

Michigan Department of Health and Human Services

Investigators

  • Principal Investigator: Mar Bicket, MD, PhD, University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 31, 2023

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

November 1, 2024

Study Registration Dates

First Submitted

July 21, 2023

First Submitted That Met QC Criteria

August 7, 2023

First Posted (Actual)

August 14, 2023

Study Record Updates

Last Update Posted (Actual)

February 8, 2024

Last Update Submitted That Met QC Criteria

February 6, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HUM00236974
  • E20233700-001 (Other Grant/Funding Number: Michigan Department of Health and Human Services)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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