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

NCT06215170 | Unknown Phase 1 DMC FDA Device

• 2 other identifiers: SafeMedWasteCT20231R43DA057750-01A1
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Opioid Use Disorder

Keywords

Opioid Use Disorder; Drug Disposal; at-home drug disposal; Drug Diversion; Opioid Disposal

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Reasons for disposal/non- disposal

  Within 3 months following surgery

• Time of disposal

  Within 3 months following surgery

• Amount of opioids used

  Within 3 months following surgery

Study Arms (2)

Control

NO INTERVENTION

General Instructions on Opioid Disposal

Treatment

ACTIVE COMPARATOR

General Instructions on opioid disposal Device: SafeMedWaste Opioid Disposal Kit

Device: SafeMedWaste

Interventions

SafeMedWaste DEVICE

SafeMedWaste opioid disposal kit

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Central Study Contacts

Justin Stas, B.S Biomedical Engineering

CONTACT

9011340; jstas@safemedwaste.com

Paisley T Myers, PhD Bioanalytical chemistry

CONTACT

803-394-8263; paisley.myers@prismahealth.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2024
• First Posted: January 22, 2024
• Study Start: February 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: February 1, 2025
• Last Updated: January 22, 2024

Record last verified: 2024-01