SurgeryMEDSAFENCT05991687
Methods for Effective Disposal of Surplus Analgesics to Facilitate Elimination
A study testing In-home drug disposal pouch and Mail-in prepaid envelope in people with Surgery and Analgesics, Opioids, run by University of Michigan at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery, Analgesics, Opioids
- What is being tested?
- In-home drug disposal pouch and Mail-in prepaid envelope
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2023to 4 Sep 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Anticipated to be prescribed and use an opioid medication to treat acute pain after elective outpatient surgery
- Opioid-naive
Who cannot join
- Inability to receive email and/or phone calls for follow up assessment
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Surgery, Analgesics, Opioids
- Being tested
- In-home drug disposal pouch, Mail-in prepaid envelope
- Keywords
- Opioids, Drug disposal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-home drug disposal pouchOther
Will receive a drug disposal pouch to inactivate leftover prescription opioids for disposal after surgery.
Mail-in prepaid envelopeOther
Will receive a prepaid envelope to mail leftover prescription opioids for disposal after surgery
| Study group | Role | What they receive |
|---|---|---|
| In-home | Active comparator | Not described Receives: Other: In-home drug disposal pouch |
| Mail-in | Active comparator | Not described Receives: Other: Mail-in prepaid envelope |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks after surgery
Secondary outcomes (5)
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
Measured: 2 weeks after surgery
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
Measured: 2 weeks after surgery
Feasibility of Intervention Measure (FIM)
Measured: 2 weeks after surgery
Acceptability of Intervention Measure (AIM)
Measured: 2 weeks after surgery
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
Measured: 2 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start31 Jul 2023
- Primary completion4 Sep 2026
- Study completion4 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Michigan Department of Health and Human Services
- Responsible party
- Principal investigator, Mark Bicket, MD, PhD, University of Michigan
- Investigators
- Mark Bicket, MD, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05991687
- Sponsor's protocol ID
- HUM00236974
- Other IDs
- E20233700-001
- Acronym
- MEDSAFE
- Status last verified
- Sep 2026
- First submitted
- 21 Jul 2023
- Last updated
- 10 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No