Safely Disposing of Surplus Prescription Opioids (DISPOSE)

Disposal Interventions for Safe Prescription Opioid Surplus Elimination: The DISPOSE Trial

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.

Study Overview

• Status: Completed
• Conditions: Opioid Use
• Intervention / Treatment: Behavioral: Informational Sheet; Behavioral: DisposeRx Drug Disposal kit

Detailed Description

Many persons who receive a prescription for opioids report having leftover opioids once the prescription is finished. Leftover prescription opioids serve as a reservoir of products for misuse, given 90% of people who misuse prescription opioids report obtaining the opioids from a friend, family member, or a legitimate prescription. The best way to increase the rate of safe disposal of leftover opioids is unclear. The present study will generate evidence comparing how well a drug disposal system compares with providing an informational handout on properly disposing of leftover prescription opioids. Participants will be randomized by day to one of two disposal interventions or no disposal intervention. Disposal interventions include a drug disposal kit or an informational sheet describing how to safely dispose of leftover prescription opioids. Storage and disposal characteristics for leftover prescription opioids will be measured using standardized telephone calls with participants at 3 weeks after filling the opioid prescription. If therapy is not concluded at 3 weeks or participants are not available, then a second standardized telephone call with participants will take place at 6 weeks after filling the opioid prescription.

• Study Type: Interventional
• Enrollment (Actual): 499
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Hospital/Johns Hopkins Outpatient Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Informational Sheet; Persons picking up an opioid prescription will receive an informational sheet that describes how to properly dispose of leftover opioid medications	Behavioral: Informational Sheet; The informational sheet details how use opioid medicines safely, and lists ways to properly dispose of leftover opioids
Active Comparator: Drug Disposal Kit; 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 Sheet; The informational sheet details how use opioid medicines safely, and lists ways to properly dispose of leftover opioids; Behavioral: DisposeRx Drug Disposal kit; 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.
No Intervention: No intervention; Persons picking up an opioid prescription will receive no additional information or materials on disposal.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants using any drug disposal method for leftover prescription opioids	Participants who report "yes" to disposing of leftover prescription opioid medication using any method	Up to 6 weeks after prescription fill
Number of participants with safe storage of prescription opioids	Participants who report "yes" to safely storing prescription opioid medication (i.e., in a locked location)	Up to 6 weeks after prescription fill
Number of participants who completed prescription opioid therapy	Participants who report "yes" to completing therapy for prescription opioid medication	Up to 6 weeks after prescription fill

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Investigators: Principal Investigator: Mark Bicket, MD, Johns Hopkins University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Helpful Links

• Provisional Drug Overdose Death Counts
• Key Substance Use and Mental Health Indicators in the United States: Results from the 2017 National Survey on Drug Use and Health

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2019
• Primary Completion (Actual): August 14, 2019
• Study Completion (Actual): August 14, 2019

Study Registration Dates

• First Submitted: February 25, 2019
• First Submitted That Met QC Criteria: February 25, 2019
• First Posted (Actual): February 26, 2019

Study Record Updates

• Last Update Posted (Actual): September 23, 2019
• Last Update Submitted That Met QC Criteria: September 20, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Leftover opioids; Unused opioids; Safe prescription opioid disposal; Drug disposal
• Other Study ID Numbers: IRB00205030

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No