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OpenTrials
Completed

NCT Number: NCT03179566

Pain and Medication Use Following Surgery

Patients will be randomized to one of two interventions intended to facilitate safe disposal of opioids after cessation following surgery. For pragmatic reasons, participants will be randomized by day to either the information sheet or the disposal bag using a block randomization schedule. To ensuring adequate sample size, patients will be enrolled for a ~4-week period following the 2-week usual care run in period. In the event that the sample size estimate has not been reached after the 4-week intervention period, additional patients will be enrolled accordingly.

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Key information

Conditions

Opioid Use

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

East Ann Arbor Ambulatory Surgery & Medical Procedures Center - Michigan Medicine

Ann Arbor, Michigan, 48109, United States

About this study

The lack of evidence-based guidelines for postoperative opioid prescribing has contributed to a surplus of opioid pills within our patients' homes and communities, increasing the potential for diversion and nonmedical use. A recent study suggests that for outpatient general surgery procedures, roughly 72% of prescribed opioids go unused. Current opioid disposal options are limited to DEA-authorized opioid collectors, including select law enforcement agencies, pharmacies, or organized pill drop events, and many patients remain unaware of these avenues. Several studies have found that few patients have knowledge about opioid disposal options and even fewer dispose of their unconsumed opioids.

Unconsumed opioids pose a diversion risk. In the 2011 National Survey on Drug Use and Health, 70.8% of those who used a prescription medication non-medically obtained the medication from a friend or relative, with or without their knowledge. Additionally, nonmedical prescription opioid use is a common pathway to heroin use. Importantly, over 80% of young intravenous drug users report initiation of prescription opioid misuse prior to heroin.

Considering that 40% of the prescriptions written by surgeons are for opioids and patients frequently have excess opioids and limited options for and/or knowledge of opioid disposal, the present study will provide patients with information and novel options for opioid disposal as part of the surgical care pathway.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Scheduled for surgery at Michigan Medicine's East Ann Arbor Ambulatory Surgery & Medical Procedures Center

Exclusion criteria

  • Unable to speak English
  • Inability to understand or complete the surveys
  • Other conditions that preclude meaningful participation in the study

Treatment and study plan

Information Sheet

Behavioral

Patients will receive an informational sheet about how to dispose of leftover opioid medication during discharge. Nurses will provide this information sheet and a brief, scripted description of its use and importance of safe disposal at the time of discharge following surgery.

Deterra Drug Deactivation System

Behavioral

This system is a pouch that deactivates prescription drugs, rendering them ineffective for misuse and safe for regular garbage disposal. It uses a patented activated carbon technology to deactivate drugs, including pills, liquids, and patches, and has been found to be 99% percent effective in studies funded by the National Institute of Drug Abuse (NIDA). Additionally, the pouches are made from environmentally friendly materials and contain active ingredients that are considered non-toxic and pose minimal risk, according to their MSDS. Nurses will provide the Deterra bag and a brief, scripted description of its use and importance of safe disposal at the time of discharge following surgery.

Primary outcomes

  1. Drug disposal

    Time frame: 4 weeks post-surgery

    Patient-reported disposal of left-over opioid medications in any manner

Secondary outcomes

  1. Opioid disposal technique

    Time frame: 4 weeks post-surgery

    Patient-reported technique for disposal of left-over opioid medications specifically assessing for safe disposal using recommended disposal methods

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Michigan Department of Health and Human Services

Registry information

Official study title

Safe Opioid Disposal After Surgery Trial

Acronym: SODAS

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jun 7, 2017
Registry last updated
Sep 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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