Opioid Use DisorderPhase 1Drug DisposalNCT06215170
SafeMedWaste At-Home, Environmentally-Friendly Opioid Disposal Kit for Orthopedic Post-Operative Surgical Patients to Reduce Opioids Available for Diversion
A Phase 1 study testing SafeMedWaste in people with Opioid Use Disorder, run by SafeMedWaste, Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- SafeMedWaste
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2024to 1 Feb 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Opioid Use Disorder
- Being tested
- SafeMedWaste
- Keywords
- Opioid Use Disorder, Drug Disposal, at-home drug disposal, Drug Diversion, Opioid Disposal
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SafeMedWasteDevice
SafeMedWaste opioid disposal kit
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | General Instructions on Opioid Disposal |
| Treatment | Active comparator | General Instructions on opioid disposal Device: SafeMedWaste Opioid Disposal Kit Receives: Device: SafeMedWaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 3 months following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start1 Feb 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SafeMedWaste, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Prisma Health-Midlands, University of South Carolina, National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06215170
- Sponsor's protocol ID
- SafeMedWasteCT2023
- Other IDs
- 1R43DA057750-01A1
- Acronym
- Drug Disposal
- Status last verified
- Jan 2024
- First submitted
- 10 Jan 2024
- Last updated
- 22 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SafeMedWaste At-Home, Environmentally-Friendly Opioid Disposal Kit for Orthopedic Post-Operative Surgical Patients to Reduce Opioids Available for Diversion
- ClinicalTrials.gov ID
- NCT06215170
- Acronym / sponsor ID
- Drug Disposal / SafeMedWasteCT2023
- Conditions
- Opioid Use Disorder
- Keywords
- Opioid Use Disorder, Drug Disposal, at-home drug disposal, Drug Diversion, Opioid Disposal
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- SafeMedWaste, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Prisma Health-Midlands, University of South Carolina, National Institute on Drug Abuse (NIDA)
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 22 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –General Instructions on Opioid Disposal |
| Treatment | Active comparator | Device: SafeMedWasteGeneral Instructions on opioid disposal Device: SafeMedWaste Opioid Disposal Kit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SafeMedWasteSafeMedWaste opioid disposal kit | Device | Treatment |
Primary outcome
Opioid disposal compliance
Time frame: Within 3 months following surgery
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Opioid Use Disorder
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Not yet recruiting
Comprehensive Opioid Management and Breathing During Sleep
Sleep-Disordered Breathing, Chronic Opioid Use
Active, not recruitingPhase 2
Wellcome Leap Psilocybin for OUD
Opioid Use Disorder
Recruiting
Opioid and Pain Treatment in Indigenous Communities (OPTIC) Trial
Opioid Use Disorder, Opioid Misuse
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SafeMedWaste in people with Opioid Use Disorder, run by SafeMedWaste, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Justin Stas, B.S Biomedical Engineering (9011340, jstas@safemedwaste.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid disposal compliance (time frame: Within 3 months following surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2024.