Ignite Creation Date:
2024-05-06 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06215170
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-22
First Post:
2024-01-10
Brief Title:
SafeMedWaste At-Home Environmentally-Friendly Opioid Disposal Kit for Orthopedic Post-Operative Surgical Patients to Reduce Opioids Available for Diversion
Sponsor:
SafeMedWaste Inc
Organization:
SafeMedWaste Inc
Study Overview
Official Title:
SafeMedWaste At-Home Environmentally-Friendly Opioid Disposal Kit for Orthopedic Post-Operative Surgical Patients to Reduce Opioids Available for Diversion
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Drug Disposal
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
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 patients MyChart account Data from the surveys will be statistically analyzed to identify significant factors that influenced patients behavior vis-à-vis opioid disposal
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 patients MyChart account Data from the surveys will be statistically analyzed to identify significant factors that influenced patients behavior vis-à-vis opioid disposal
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R43DA057750-01A1 | NIH | None | httpsreporternihgovquickSearch1R43DA057750-01A1 |