SafeMedWaste At-Home, Environmentally-Friendly Opioid Disposal Kit for Orthopedic Post-Operative Surgical Patients to Reduce Opioids Available for Diversion (Drug Disposal)

There is an urgent unmet medical need for a cost-effective, environmentally friendly, in-home opioid disposal solution for surgical patients that is clinically proven to reduce opioid use disorder that is substantiated with economic data. SafeMedWaste, Inc. (SMW) has developed the patented SafeMedWaste in-home drug disposal container, that completely destroys opioids within minutes and can be placed in the regular trash, without risk of ground or municipal water contamination.

A pilot randomized clinical trial will evaluate the use of SafeMedWaste in 300 adult patients in outpatient surgery clinics undergoing shoulder and knee surgery.

Study Overview

• Status: Not yet recruiting
• Conditions: Opioid Use Disorder
• Intervention / Treatment: Device: SafeMedWaste

Detailed Description

The trial will evaluate opioid disposal rates and events related to opioid diversion and use disorder in 300 adult patients 18 years of age and older undergoing outpatient knee and shoulder surgery who are prescribed opioids to manage their acute post-surgical pain.

Patients will be randomized into two arms. During the standard of care post op visits (2-, 6- and 10- weeks), when the treating physician has determined that the patient will no longer need opioids to manage their post-surgical pain, all patients will receive general instructions by video on opioid disposal recorded by one of the orthopedic surgeons. Patients in the treatment arm will also be given the SafeMedWaste opioid disposal system and watch an instructional video on how to use the product.

All patients will complete a pre-surgery survey and a post-surgery survey 90 days after surgery. Patients will self-report their disposal or non-disposal of the drugs, documented with pictures uploaded to the patient's MyChart account. Data from the surveys will be statistically analyzed to identify significant factors that influenced patients' behavior vis-à-vis opioid disposal.

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Justin Stas, B.S Biomedical Engineering; Phone Number: 9011340; Email: jstas@safemedwaste.com
• Study Contact Backup: Name: Paisley T Myers, PhD Bioanalytical chemistry; Phone Number: 803-394-8263; Email: paisley.myers@prismahealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Inclusion Criteria:

  • Subject is 18 + years of age
  • Subject is opioid naive (within the last 3 months), as evidenced by MyChart patient record or response to medical history questions
  • Subject is scheduled to undergo shoulder and/or knee surgery

Exclusion Criteria:

• Subject has a history of opioid addiction, as evidenced by MyChart patient record or response to medical history questions
• Subject is currently utilizing prescription narcotics for any reason, as evidenced by MyChart patient record or response to medical history questions
• Subject does not have the mental capacity to make their own healthcare decisions
• Subject is unable to provide written consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; General Instructions on Opioid Disposal
Active Comparator: Treatment; General Instructions on opioid disposal Device: SafeMedWaste Opioid Disposal Kit	Device: SafeMedWaste; SafeMedWaste opioid disposal kit

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid disposal compliance	Opioid disposal compliance will be tracked up to 3 months post-surgery, as reported by patients in post-surgery survey and/or documented with pictures uploaded by patient to MyChart.	Within 3 months following surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reasons for disposal/non- disposal	Reasons why the patient chose to dispose of opioids or chose not to, as reported in the post- surgery survey, will be statistically analyzed and correlated as appropriate to other data.	Within 3 months following surgery
Time of disposal	When the patients dispose of opioids, as reported by patients in post-surgery survey and/or documented with pictures in MyChart, will be tracked up to 3 months post-surgery.	Within 3 months following surgery
Amount of opioids used	The amount of opioids used will be tracked at visit weeks 2, 6 and 10, post surgery, through clinic pill counts, or as self-reported by patients up to 3 months.	Within 3 months following surgery
Opioid Use Disorder (OUD)	Any OUD reported in the patient medical record will be tracked up to 3 months following surgery.	Within 3 months following surgery
Diversion event	Any diversion event as described by patient at clinical visit or in post-surgery survey will be recorded.	Within 3 months following surgery
Pre-Surgery Survey	Pre-Surgery Survey, see Ex. 1, Protection of Human Subjects, will be completed by patients at enrollment. Questions include patient past surgical experience and attitudes toward pain. Data will be recorded in REDCap and statistically analyzed.	At enrollment
Post-Surgery Survey	Patients will answer post-surgery survey, see Ex. 2, Protection of Human Subjects, within 3 months following surgery. Questions include pain experiences from their surgery and disposal compliance. Data will be recorded in REDCAP and statistically analyzed for correlations of patient attitudes toward and experience with pain and other factors to disposal compliance to create clinician/patient education protocols to be studied in future trial.	3 months following surgery
Provider Satisfaction Survey	Provider participants will answer Provider Satisfaction survey, see Ex. 4, Protection of Human Subjects, upon study completion. Data will be recorded in REDCap and statistically analyzed.	Upon study completion

Collaborators and Investigators

• Sponsor: SafeMedWaste, Inc.
• Collaborators: National Institute on Drug Abuse (NIDA); University of South Carolina; Prisma Health-Midlands

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: January 10, 2024
• First Submitted That Met QC Criteria: January 10, 2024
• First Posted (Actual): January 22, 2024

Study Record Updates

• Last Update Posted (Actual): January 22, 2024
• Last Update Submitted That Met QC Criteria: January 10, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Opioid Use Disorder; Drug Disposal; at-home drug disposal; Drug Diversion; Opioid Disposal
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Narcotic-Related Disorders; Opioid-Related Disorders
• Other Study ID Numbers: SafeMedWasteCT2023; 1R43DA057750-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No