NCT05991687

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable surgery

Timeline
3mo left

Started Jul 2023

Typical duration for not_applicable surgery

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress92%
Jul 2023Aug 2026

First Submitted

Initial submission to the registry

July 21, 2023

Completed
10 days until next milestone

Study Start

First participant enrolled

July 31, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

3 years

First QC Date

July 21, 2023

Last Update Submit

March 10, 2026

Conditions

SurgeryAnalgesics, Opioids

Keywords

OpioidsDrug disposal

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Use of safe disposal method

    2 weeks after surgery

  • Use of any disposal method

    2 weeks after surgery

  • Feasibility of Intervention Measure (FIM)

    2 weeks after surgery

  • Acceptability of Intervention Measure (AIM)

    2 weeks after surgery

  • Patient-Reported Satisfaction with Use of Disposal Method (study derived question)

    2 weeks after surgery

Study Arms (2)

In-home

ACTIVE COMPARATOR
Other: In-home drug disposal pouch

Mail-in

ACTIVE COMPARATOR
Other: Mail-in prepaid envelope

Interventions

In-home drug disposal pouchOTHER

Will receive a drug disposal pouch to inactivate leftover prescription opioids for disposal after surgery.

In-home
Mail-in prepaid envelopeOTHER

Will receive a prepaid envelope to mail leftover prescription opioids for disposal after surgery

Mail-in

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

Study Officials

  • Mark Bicket, MD, PhD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Heather Lipkovitch

CONTACT

734-936-4280hlipkovi@umich.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 21, 2023

First Posted

August 14, 2023

Study Start

July 31, 2023

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

March 12, 2026

Record last verified: 2026-03

Locations

US(1)