MEDSAFE: Methods for Effective Disposal of Surplus Analgesics to Facilitate Elimination

• Sponsor: University of Michigan (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05991687
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 1
• Patients Per Site Per Month: 98.2

Study Details

Study Description

Brief Summary

The primary objective is to evaluate the difference in outcomes for mail-in vs. in-home disposal methods for leftover prescription opioids after discharge from surgery.

Condition or Disease	Intervention/Treatment	Phase
Surgery; Analgesics, Opioids	Other: In-home drug disposal pouch; Other: Mail-in prepaid envelope	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Methods for Effective Disposal of Surplus Analgesics to Facilitate Elimination
• Anticipated Study Start Date: Aug 1, 2023
• Anticipated Primary Completion Date: Sep 1, 2023
• Anticipated Study Completion Date: Sep 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: In-home	Other: In-home drug disposal pouch; Will receive a drug disposal pouch to inactivate leftover prescription opioids for disposal after surgery.
Active Comparator: Mail-in	Other: Mail-in prepaid envelope; Will receive a prepaid envelope to mail leftover prescription opioids for disposal after surgery

Outcome Measures

Primary Outcome Measures

1. Use of assigned disposal method [2 weeks after surgery]

   Among patients who have leftover opioids, patient report of the use of their assigned mail-in or in-home method of disposal by 2 weeks after surgery.

Secondary Outcome Measures

1. Use of safe disposal method [2 weeks after surgery]

   Patient-reported use of a method for disposal of leftover opioids that includes mail-in, in-home, pharmacy drop off, or flushing down the toilet by

2. Use of any disposal method [2 weeks after surgery]

   Patient-reported use of any method to dispose of leftover opioids, that includes assigned methods, safe methods, and other methods such as placing in the trash

3. Feasibility of Intervention Measure (FIM) [2 weeks after surgery]

4. Acceptability of Intervention Measure (AIM) [2 weeks after surgery]

5. Patient-Reported Satisfaction with Use of Disposal Method (study derived question) [2 weeks after surgery]

   Patient report of overall satisfaction with use of the assigned disposal method, on a 0 (worst) to 10 (best) numeric scale

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Anticipated to be prescribed and use an opioid medication to treat acute pain after elective outpatient surgery

• Opioid-naive

Exclusion Criteria:

• Inability to receive email and/or phone calls for follow up assessment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Michigan	Ann Arbor	Michigan	United States	48109

Sponsors and Collaborators

• University of Michigan

Investigators

• Principal Investigator: Mar Bicket, MD, PhD, University of Michigan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mark Bicket, MD, PhD, Assistant Professor, University of Michigan
• ClinicalTrials.gov Identifier: NCT05991687
• Other Study ID Numbers: HUM00236974
• First Posted: Aug 14, 2023
• Last Update Posted: Aug 14, 2023
• Last Verified: Aug 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Mark Bicket, MD, PhD, Assistant Professor, University of Michigan: Opioids; Drug disposal

Study Results

No Results Posted as of Aug 14, 2023