CClinicalTrials.gg
CompletedNCT04553588Updated Sep 17, 2020

Effect of an Opioid Disposal Pouch Versus Usual Care on Post Discharge Disposal of Unused Medication

An interventional study of Disposal pouch in Drug Prescriptions, sponsored by The Cleveland Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-09-17.

Sponsored by The Cleveland Clinic · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 3 years 1 month after the study started (first participant enrolled Jul 2017, registered Sep 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
313
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of the study is to determine if opioid disposal bags/pouches are an effective method for disposing of unused opioid medications postoperatively

Read the detailed description

Opioids are dispensed regularly to manage postoperative pain in patients undergoing surgery in hospitals and same day surgery centers. There has been a rise in the number of opioid misuse and overdoses nationally, with Ohio ranked first in the nation for drug overdose deaths in 2014 and Cuyahoga County leading the state with 666 overdose deaths in 2016(ref) As health care providers, it is our responsibility to respond to this epidemic. One measure to address this is to reduce the number of unused prescription opioids that remain in patients' possession when they no longer need them. (ref) Doing so will maximize safety by decreasing the availability of unused opioids. The purpose of this study is to determine if a product that deactivates opioids will be used as designed after oral opioid medication is no longer needed. The design of this study is a quality initiative project using a randomized control design. The setting is a surgery center in a suburban hospital in Cuyahoga County. The population is all adult surgery center patients that are prescribed opioids postoperatively who are discharged the same day. In addition to usual care, a medication disposal bag with instructions on how to use will be given to the patient prior to discharge. The patient will be called 30-45 days post discharge. The data will be collected on a case report form that will include information about disposal and information obtained from the patients medical record.

02

Conditions studied

  • Drug Prescriptions

Keywords

  • opioid misuse
  • disposal
  • disposal pouch
  • postoperative surgery
03

In context

Lead sponsor

The Cleveland Clinic is the lead sponsor of 818 studies on the registry; 118 are open to participants now.

Of its 89 completed or terminated interventional studies of FDA-regulated products, 72 (81%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Adults (>18 years)
  • Scheduled to go home on the day of surgery
  • Received a prescription for opioids
  • Willing to provide a telephone number and receive a phone call 30 days after surgery

Exclusion criteria

Exclusion Criteria

  • Moderate to severe cognitive decline requiring caregiver support
  • Not able to speak or understand English (instructions only available in English)
  • Behavioral health diagnosis
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Care provider)
Enrollment
313 participants (actual)

Study arms

  • Active comparator
    Opioid Disposal Pouch

    an opioid disposal pouch to inactivate and dispose of unused opioid medication within the first 30 days after surgery

    Other: Disposal pouch

  • No intervention
    Usual Care

    usual medication disposal includes multiple options as desired by patient; for example, flushing down toilet, giving to local pharmacist, giving to police department etc.

Interventions

  • OtherDisposal pouch

    Medication Disposal Pouch

    Also known as: Medsaway Pouch

06

What researchers measure

Primary outcomes

  1. Rate of Disposal of Unused Opioid Medication

    rate of patient reported unused oral opioid medication disposal between groups

    Time frame: 30 days postoperatively

Secondary outcomes

  1. Odds of disposal pouch use after adjusting for group assignment

    Odds of disposal pouch use after adjusting for group assignment (usual care versus disposal pouch group)

    Time frame: 30 days postoperatively

  2. Odds of disposal pouch use after adjusting for pain level on the worst day of postoperative pain

    Odds of disposal pouch use after adjusting for pain level on the worst day of postoperative pain

    Time frame: 30 days postoperatively

  3. Odds of disposal pouch use after adjusting for preoperative opioid use

    Odds of disposal pouch use after adjusting for preoperative opioid use

    Time frame: 30 days postoperatively

  4. Odds of disposal pouch use after adjusting for race

    Odds of disposal pouch use after adjusting for race

    Time frame: 30 days postoperatively

  5. Odds of disposal pouch use after adjusting for gender

    Odds of disposal pouch use after adjusting for gender

    Time frame: 30 days postoperatively

  6. Odds of disposal pouch use after adjusting for surgical procedure type

    Odds of disposal pouch use after adjusting for surgical procedure type

    Time frame: 30 days postoperatively

  7. Odds of disposal pouch use after adjusting for insurance type

    Odds of disposal pouch use after adjusting for insurance type

    Time frame: 30 days

07

Study locations

1 site
  • Cleveland Clinic Health System
    Cleveland, Ohio 44195, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 17, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04553588
Lead sponsor
The Cleveland Clinic
Responsible party
Antoinette Zito (Perioperative Educator, Office of Nursing Education and Professional Development, Principal Investigator, The Cleveland Clinic) — Principal investigator
First posted
Sep 17, 2020
Start date
Jul 15, 2017
Primary completion
May 31, 2018
Completion
Feb 27, 2020
Last update
Sep 17, 2020

Study contacts

Zito Antoinette, MSN
principal investigator · Cleveland Clinic Health System

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

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