Medication DisposalNCT03285061

Excess Opioid Disposal Following Orthopedic Foot and Ankle Surgery

A study testing Deterra Drug Deactivation System in people with Medication Disposal and Behavior, run by Brigham and Women's Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Medication Disposal, Behavior
What is being tested?: Deterra Drug Deactivation System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 75 participants
Where: 1 siteUnited States
Study dates: 1 Oct 2017to 1 Jul 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Brigham and Women's Hospital
Boston, Massachusetts, 02130

Other trials in United States

About this study

Conditions: Medication Disposal, Behavior
Being tested: Deterra Drug Deactivation System
Medical subject headings: Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Deterra Drug Deactivation SystemDevice
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.

Study groups in NCT03285061
Study group	Role	What they receive
Standard Disposal Instructions	No intervention	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.
At Home Disposal	Experimental	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. Receives: Device: Deterra Drug Deactivation System

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 20171 Jul 2019

First posted15 Sep 2017
Study start1 Oct 2017
Primary completion1 Jul 2019
Study completion1 Jul 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Medication DisposalStudies of the same condition, open and under way.
More trials run by Brigham and Women's HospitalThe 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: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 75 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03285061
Sponsor's protocol ID: 2017P002031
Status last verified: Jan 2021
First submitted: 14 Sep 2017
Last updated: 6 Jan 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No: IPD will not be shared with other researchers or organizations.

Study at a glance

From the registry record, last updated by the sponsor on 6 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Excess Opioid Disposal Following Orthopedic Foot and Ankle Surgery
ClinicalTrials.gov ID: NCT03285061
Acronym / sponsor ID: 2017P002031
Conditions: Medication Disposal, Behavior
Study type: Interventional
Recruitment status: Completed
Enrolment: 75 participants (actual)
Lead sponsor: Brigham and Women's HospitalUniversity, hospital or other
Study start: 1 Oct 2017 (actual)
Primary completion: 1 Jul 2019 (actual)
Study completion: 1 Jul 2019 (actual)
First posted: 15 Sep 2017 (actual)
Results: Posted 6 Jan 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Standard Disposal Instructions	No intervention	–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.
At Home Disposal	Experimental	Device: Deterra Drug Deactivation SystemWith 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (1 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Deterra Drug Deactivation SystemA 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.	Device	At Home Disposal

Primary outcome

Number of Participants Who Safely Disposed The Excess Medication
Time frame: 6 weeks
Patients will be given a survey to obtain their method of disposal for excess post-operative pain medication.

Results and safety

Results posted to the registry on 6 Jan 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Standard Disposal Instructions	37	36
At Home Disposal	38	36

Primary outcome: Number of Participants Who Safely Disposed The Excess Medication

Time frame: 6 weeks. Count of participants. Unit: Participants

Measure	Standard Disposal Instructions n = 21	At Home Disposal n = 26
Value	8	22

Population analysed: These two populations constitute a subgroup of all patients initially enrolled in the study. Specifically, these two populations constitute those patients that had leftover medications (as opposed to all patients who were enrolled in the trial). For this reason, these numbers are disparate from those of the Results Participant Flow.

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Standard Disposal Instructions	0 of 0	0 of 37 (0%)	0
At Home Disposal	0 of 0	0 of 38 (0%)	0

Limitations and caveats (from the sponsor): * 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

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Deactivation System WebsiteLink provided by the sponsor.
Individual participant dataSharing planned: No. IPD will not be shared with other researchers or organizations.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Christopher Chiodo, MD principal investigator

Brigham and Women's Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Deterra Drug Deactivation System in people with Medication Disposal and Behavior, run by Brigham and Women's Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Safely Disposed The Excess Medication (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03285061.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2021.