Status:
NOT_YET_RECRUITING
SafeMedWaste At-Home, Environmentally-Friendly Opioid Disposal Kit for Orthopedic Post-Operative Surgical Patients to Reduce Opioids Available for Diversion
Lead Sponsor:
SafeMedWaste, Inc.
Collaborating Sponsors:
Prisma Health-Midlands
University of South Carolina
Conditions:
Opioid Use Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 tha...
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 wh...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2025
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06215170
Start Date
February 1 2024
End Date
February 1 2025
Last Update
January 22 2024
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