Clinical trial NCT06215170: SafeMedWaste At-Home, Environmentally-Friendly Opioid Disposal Kit for Orthopedic Post-Operative Surgical Patients to Reduce Opioids Available for Diversion
Official title: SafeMedWaste At-Home, Environmentally-Friendly Opioid Disposal Kit for Orthopedic Post-Operative Surgical Patients to Reduce Opioids Available for Diversion
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Opioid Use Disorder
Keywords: Opioid Use Disorder
Drug Disposal
at-home drug disposal
Drug Diversion
Opioid Disposal
Lead sponsor: SafeMedWaste, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Prisma Health-Midlands
name: University of South Carolina
name: National Institute on Drug Abuse (NIDA)
First posted: 2024-01-22
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Opioid disposal compliance
timeFrame: Within 3 months following surgery
Secondary outcomes:
Other outcomes:
measure: Reasons for disposal/non- disposal
timeFrame: Within 3 months following surgery
measure: Time of disposal
timeFrame: Within 3 months following surgery
measure: Amount of opioids used
timeFrame: Within 3 months following surgery
measure: Opioid Use Disorder (OUD)
timeFrame: Within 3 months following surgery
measure: Diversion event
timeFrame: Within 3 months following surgery
measure: Pre-Surgery Survey
timeFrame: At enrollment
measure: Post-Surgery Survey
timeFrame: 3 months following surgery
measure: Provider Satisfaction Survey
timeFrame: Upon study completion
Locations:
Study officials:
References: