NCT03855241

Brief Summary

This study evaluates two interventions intended to increase the safe disposal of leftover prescription opioids, compared to no intervention. Participants will receive an informational sheet describing how to safely dispose of leftover prescription opioids, an informational sheet with a drug disposal kit, or no intervention. Participants will be randomized by day for pragmatic reasons.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
499

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 26, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

June 5, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 14, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 14, 2019

Completed
Last Updated

September 23, 2019

Status Verified

September 1, 2019

Enrollment Period

2 months

First QC Date

February 25, 2019

Last Update Submit

September 20, 2019

Conditions

Opioid Use

Keywords

Leftover opioidsUnused opioidsSafe prescription opioid disposalDrug disposal

Outcome Measures

Primary Outcomes (1)

  • Number of participants using a safe drug disposal method for leftover prescription opioids

    Participants who report "yes" to disposing of leftover prescription opioid medication using a disposal intervention that aligns with recommendations from the Food and Drug Administration (i.e., using a take-back program, drug disposal kit, or flushing in the toilet)

    Up to 6 weeks after prescription fill

Secondary Outcomes (3)

  • Number of participants using any drug disposal method for leftover prescription opioids

    Up to 6 weeks after prescription fill

  • Number of participants with safe storage of prescription opioids

    Up to 6 weeks after prescription fill

  • Number of participants who completed prescription opioid therapy

    Up to 6 weeks after prescription fill

Study Arms (3)

Informational Sheet

ACTIVE COMPARATOR

Persons picking up an opioid prescription will receive an informational sheet that describes how to properly dispose of leftover opioid medications

Behavioral: Informational Sheet

Drug Disposal Kit

ACTIVE COMPARATOR

Persons picking up an opioid prescription will receive a drug disposal kit (DisposeRx Drug Disposal kit) and instructions on how to use it

Behavioral: Informational SheetBehavioral: DisposeRx Drug Disposal kit

No intervention

NO INTERVENTION

Persons picking up an opioid prescription will receive no additional information or materials on disposal.

Interventions

Informational SheetBEHAVIORAL

The informational sheet details how use opioid medicines safely, and lists ways to properly dispose of leftover opioids

Drug Disposal KitInformational Sheet
DisposeRx Drug Disposal kitBEHAVIORAL

DisposeRx is a powder that is activated with water and traps leftover drugs (i.e. pills, capsules, caplets, liquids or tablets) in a semi-solid gel. The trapped drug cannot be retrieved from the resulting gel material for misuse, abuse or to leach into landfills. The participant can then throw away the biodegradable solid material in the prescription bottle into the trash, as it is safe for the environment.

Drug Disposal Kit

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult participants (age ≥ 18 years) who pick up a prescription for themselves or a family member at a Johns Hopkins pharmacy
  • English speaking
  • Residential address and phone number in the United States
  • Filling a new prescription consisting of an immediate release opioid medication (i.e., immediate release morphine, oxycodone, hydromorphone, hydrocodone, tramadol; alone or in combination with acetaminophen) with ≤ 7 days' supply

You may not qualify if:

  • Age \< 18 years
  • Non-English speaking
  • Residential address and/or phone number outside the United States
  • Opioid medication listed in participant's active medication list prior to prescription fill
  • Filling any prescription consisting of any opioid with 8 or more days' supply
  • Filling any prescription consisting of any extended-release / long-acting opioid medication (i.e., extended-release morphine, oxymorphone, oxycodone, hydromorphone, fentanyl, methadone, buprenorphine)
  • Filling an opioid prescription indicated for cough or shortness of breath

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Hospital/Johns Hopkins Outpatient Center

Baltimore, Maryland, 21287, United States

Location

Related Publications (4)

  • Bicket MC, Long JJ, Pronovost PJ, Alexander GC, Wu CL. Prescription Opioid Analgesics Commonly Unused After Surgery: A Systematic Review. JAMA Surg. 2017 Nov 1;152(11):1066-1071. doi: 10.1001/jamasurg.2017.0831.

    PMID: 28768328BACKGROUND

  • Maughan BC, Hersh EV, Shofer FS, Wanner KJ, Archer E, Carrasco LR, Rhodes KV. Unused opioid analgesics and drug disposal following outpatient dental surgery: A randomized controlled trial. Drug Alcohol Depend. 2016 Nov 1;168:328-334. doi: 10.1016/j.drugalcdep.2016.08.016. Epub 2016 Sep 20.

    PMID: 27663358BACKGROUND

  • Rose P, Sakai J, Argue R, Froehlich K, Tang R. Opioid information pamphlet increases postoperative opioid disposal rates: a before versus after quality improvement study. Can J Anaesth. 2016 Jan;63(1):31-7. doi: 10.1007/s12630-015-0502-0. Epub 2015 Oct 2.

    PMID: 26431852BACKGROUND

  • Bicket MC, Fu D, Swarthout MD, White E, Nesbit SA, Monitto CL. Effect of Drug Disposal Kits and Fact Sheets on Elimination of Leftover Prescription Opioids: The DISPOSE Multi-Arm Randomized Controlled Trial. Pain Med. 2021 Apr 20;22(4):961-969. doi: 10.1093/pm/pnaa431.

    PMID: 33576394DERIVED

Related Links

Study Officials

  • Mark Bicket, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessors are unaware of treatment assignment
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2019

First Posted

February 26, 2019

Study Start

June 5, 2019

Primary Completion

August 14, 2019

Study Completion

August 14, 2019

Last Updated

September 23, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)