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Safe Return and Disposal of Unused Opioids

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03352479
Recruitment Status : Not yet recruiting
First Posted : November 24, 2017
Last Update Posted : November 24, 2017
Information provided by (Responsible Party):
Adam Adler MD, MS, FAAP, Baylor College of Medicine

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.

Condition or disease Intervention/treatment Phase
Opioid Use Opioid Dependence Opioid Abuse, Unspecified Other: Opioid Return Not Applicable

Detailed Description:

Participants identified by the PI and participating research staff/coordinators that will receive opioids following discharge will be approached. The participant information sheet will be provided to the parents/legal guardian and explained. The consenting study coordinator will review the potential risks of opioids as described in the information sheet. A brief demonstration of the TakeAway envelope will be provided. The participants will be instructed that there is absolutely no cost to them or their family and that the envelope is pre-paid and that all returned or unreturned contents are strictly confidential. A few brief demographic questions will be asked and are completely optional. The participant will be asked for an email and contacted 15 days and 30 days following the procedure. The email will strictly be a reminder to return all un-used medication using the provided envelope Or an optional response reporting nothing to return. If participants do not have an email or do not wish to be contacted, they may still enroll in the study. The entire peri-operative period will progress in the usual manner.

Each envelope has a serial number that will be recorded during enrollment - the company provides access to ascertain exactly how many pills are returned. This access is strictly provided to the PI. The company will have no patient information and therefore only the PI will be able to track the serial number to the patient. The PI and research staff will record the number of pills prescribed to the patient to allow the research team to calculate the percentage of pills returned.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Each participant will be given on envelope to return unused opioids
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Keeping Your Children and Home Safe Through Return and Disposal of Unused Opioids
Estimated Study Start Date : December 1, 2017
Estimated Primary Completion Date : June 30, 2018
Estimated Study Completion Date : July 30, 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Opioids Prescribed
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
Calculate the percentage of prescribed to returned opioids

Primary Outcome Measures :
  1. % of prescribed unused opioids returned [ Time Frame: six months ]
    Calculate the percentage of opioids that are prescribed that are safely returned by participants and their families

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   up to 64 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03352479

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Contact: Adam C Adler, MD 832-824-5800
Contact: Arvind Chandrakantan, MD 832-8245800

Sponsors and Collaborators
Baylor College of Medicine

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Responsible Party: Adam Adler MD, MS, FAAP, Assistant Professor of Anesthesiology, Baylor College of Medicine Identifier: NCT03352479     History of Changes
Other Study ID Numbers: H42451
First Posted: November 24, 2017    Key Record Dates
Last Update Posted: November 24, 2017
Last Verified: November 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Substance-Related Disorders
Opioid-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents