SafeMedWaste At-Home, Environmentally-Friendly Opioid Disposal Kit for Orthopedic Post-Operative Surgical Patients to Reduce Opioids Available for Diversion
NCT06215170 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 300
Last updated 2024-01-22
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
Interventions
- DEVICE
-
SafeMedWaste
SafeMedWaste opioid disposal kit
Sponsors & Collaborators
-
Prisma Health-Midlands
collaborator OTHER -
University of South Carolina
collaborator OTHER -
National Institute on Drug Abuse (NIDA)
collaborator NIH -
SafeMedWaste, Inc.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-02-01
- Primary Completion
- 2024-12-31
- Completion
- 2025-02-01
- FDA Device
- Yes
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