SafeMedWaste At-Home, Environmentally-Friendly Opioid Disposal Kit for Orthopedic Post-Operative Surgical Patients to Reduce Opioids Available for Diversion

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-01

Study Completion Date

2025-02-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Distribution of Medication Disposal Packets - Acute Opioid Prescribing

NCT05169281

Orthopedic Surgery Neurosurgery Surgery +2 more

COMPLETED NA

Pain and Medication Use Following Surgery

NCT03179566

Opioid Use

COMPLETED NA

Patient Utilization of Opioid Destruction Bags in the Post-op Period

NCT05875857

Opioid Use Opioid Use, Unspecified Patient Empowerment +2 more

ACTIVE_NOT_RECRUITING NA

Decreasing Narcotics in Advanced Pelvic Surgery

NCT02110719

Narcotic Use Pain Constipation +1 more

COMPLETED PHASE4

Opioid Consumption and Disposal After Shoulder Arthroplasty

NCT05525975

Opioid Use

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Opioid Use Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control

General Instructions on Opioid Disposal

Group Type NO_INTERVENTION

No interventions assigned to this group

Treatment

General Instructions on opioid disposal Device: SafeMedWaste Opioid Disposal Kit

Group Type ACTIVE_COMPARATOR

SafeMedWaste

Intervention Type DEVICE

SafeMedWaste opioid disposal kit

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SafeMedWaste

SafeMedWaste opioid disposal kit

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes