ClinicalTrials.gg
CompletedNCT03285061Updated Jan 6, 2021Results posted

Excess Opioid Disposal Following Orthopedic Foot and Ankle Surgery

An interventional study of Deterra Drug Deactivation System in Medication Disposal and Behavior, sponsored by Brigham and Women's Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-06.

Sponsored by Brigham and Women's Hospital · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
75
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This study aims to survey the drug disposal methods of orthopedic foot and ankle patients with excess pain medication following and operation. The study is a randomized control trial comparing the use of FDA approved at home disposal methods to current clinical methods of recommending disposal at medication drop off locations.

02

Conditions studied

  • Medication Disposal
  • Behavior

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03

In context

Behavior

1,573 studies on the registry are indexed under Behavior; 313 are open to participants now.

This study's enrollment of 75 is below the median of 120 across 1,197 interventional studies indexed under Behavior.

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Lead sponsor

Brigham and Women's Hospital is the lead sponsor of 1,267 studies on the registry; 228 are open to participants now.

Of its 116 completed or terminated interventional studies of FDA-regulated products, 65 (56%) 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
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • This study will include foot and ankle orthopedic patients at Brigham and Women's Hospital undergoing a surgical procedure.

Exclusion criteria

Exclusion Criteria:

  • Those under age 18 will be excluded from this study, as their variation in care could affect the data. We will also exclude adults with impaired decision-making capacity and adults who take methadone or have a history of prior opioid dependence.
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
75 participants (actual)

Study arms

  • No intervention
    Standard Disposal Instructions

    These patients will receive standard instructions on proper disposal of excess pain medication following orthopedic foot and ankle surgery. They will be asked complete a survey at their 6 post operative follow-up on excess medication disposal.

  • Experimental
    At Home Disposal

    With patients' prescription for post operative pain medication, a Deterra portable drug deactivation system will be provided, along with instructions on proper use. They will be asked complete a survey at their 6 post operative follow-up on excess medication disposal.

    Device: Deterra Drug Deactivation System

Interventions

  • DeviceDeterra Drug Deactivation System

    A portable bag that will neutralize and dissolve excess medication, rendering it completely unusable and safe for landfill disposal. The system meets FDA and DEA standards for at home disposal systems.

06

What researchers measure

Primary outcomes

  1. Number of Participants Who Safely Disposed The Excess Medication

    Patients will be given a survey to obtain their method of disposal for excess post-operative pain medication.

    Time frame: 6 weeks

07

Results

Posted Jan 6, 2021
Limitations and caveats
* Single site study: results may not be replicable in other settings or in patients undergoing other procedures * Potential for reporting bias * Patients may have felt social pressure to properly dispose of medication * Since the time of this study, the FDA has conditionally endorsed flushing unused dangerous medications down the toilet in instances in which a take back location is not available. * Amounts initially prescribed and leftover were not recorded

Participant flow

Participant flow — Overall Study
MilestoneStandard Disposal InstructionsAt Home Disposal
Started3738
Completed3636
Not completed12

Outcome measures

PrimaryNumber of Participants Who Safely Disposed The Excess Medication

Patients will be given a survey to obtain their method of disposal for excess post-operative pain medication.

Time frame:
6 weeks
Reported as:
Count of participants · Participants
Number of Participants Who Safely Disposed The Excess Medication
ParticipantsStandard Disposal InstructionsAt Home Disposal
Number of Participants Who Safely Disposed The Excess Medication822

Adverse events

Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Standard Disposal Instructions——0/37 (0%)
At Home Disposal——0/38 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Standard Disposal InstructionsAt Home DisposalTotal
<=18 years000
Between 18 and 65 years343670
>=65 years325
Sex: Female, Male
Sex: Female, Male(Participants)Standard Disposal InstructionsAt Home DisposalTotal
Female242751
Male131124
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Standard Disposal InstructionsAt Home DisposalTotal
Count of participants——0
08

Study locations

1 site
  • Brigham and Women's Hospital
    Boston, Massachusetts 02130, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No — IPD will not be shared with other researchers or organizations.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 6, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03285061
Responsible party
Christopher Chiodo (Attending Orthopedic Surgeon and Chief of the Foot and Ankle Service at the Brigham and Women's and Faulkner Hospitals, Brigham and Women's Hospital) — Principal investigator
First posted
Sep 15, 2017
Start date
Oct 1, 2017
Primary completion
Jul 1, 2019
Completion
Jul 1, 2019
Results posted
Jan 6, 2021
Last update
Jan 6, 2021

Study contacts

Christopher Chiodo, MD
principal investigator · Brigham and Women's Hospital

Oversight

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

Not currently enrolling

This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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