NCT03352479

Brief Summary

The opioid epidemic in the United States has become a clear health and safety concern for our children and families. Opioids given to our patients for the treatment of pain that go unused after the immediate post operative period pose a major hazard when left in the home unattended. Opioids can be accidentally ingested by small children or deliberately ingested by pre-teens and adolescents leading to major morbidity and or death. Additionally, studies have shown that many people addicted to opioids/narcotics have become so due to ingestion of medically prescribed drugs. Finally, there has been an increase number of home robberies specifically with the intent to steal prescription drugs. Removal of unused medication from the home is an important public safety concern to protect our patients, families and friends. The Sharps Co (R), offers a product called Takeaway Medication Recovery System. This product allows individuals to put unused opioids in a pre-paid envelope which is returned to the company through the postal system and properly incinerated. This provides safe disposal in accordance with the Environmental Protection Agency (EPA) to protect the water table from contamination by drugs disposed of my other means. This system through the Sharps Co would allow for de-identified tracking of returned drugs.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2017

Shorter than P25 for not_applicable

Status
withdrawn

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

First Submitted

Initial submission to the registry

November 21, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 24, 2017

Completed
7 days until next milestone

Study Start

First participant enrolled

December 1, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2018

Completed
Last Updated

March 31, 2020

Status Verified

March 1, 2020

Enrollment Period

7 months

First QC Date

November 21, 2017

Last Update Submit

March 27, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • % of prescribed unused opioids returned

    Calculate the percentage of opioids that are prescribed that are safely returned by participants and their families

    six months

Study Arms (1)

Opioids Prescribed

OTHER

Each participant in the study will be given an envelope for return of unused opioids. The percentage of returned number of opioids will be calculated based on the number prescribed

Other: Opioid Return

Interventions

Calculate the percentage of prescribed to returned opioids

Opioids Prescribed

Eligibility Criteria

AgeUp to 64 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • All patients being prescribed opioids at discharge in the Clinical Care Center/Wallace Tower Surgical Center or at the Woodlands Campus who have undergone a surgical procedure.

You may not qualify if:

  • Parental Refusal to participate Patients not being prescribed opioids for discharge Patients on chronic opioid therapy/chronic pain patients International patients returning abroad (these takeaway envelopes are only paid through the 50 US states, DC and Puerto Rico)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Adler AC, Yamani AN, Sutton CD, Guffey DM, Chandrakantan A. Mail-Back Envelopes for Retrieval of Opioids After Pediatric Surgery. Pediatrics. 2020 Mar;145(3):e20192449. doi: 10.1542/peds.2019-2449. Epub 2020 Feb 12.

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Each participant will be given on envelope to return unused opioids
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Anesthesiology

Study Record Dates

First Submitted

November 21, 2017

First Posted

November 24, 2017

Study Start

December 1, 2017

Primary Completion

June 30, 2018

Study Completion

July 30, 2018

Last Updated

March 31, 2020

Record last verified: 2020-03