Safely Disposing of Surplus Prescription Opioids (DISPOSE)

• ClinicalTrials.gov Identifier: NCT03855241
• Recruitment Status: Completed
• First Posted: February 26, 2019
• Last Update Posted: September 23, 2019
• Sponsor: Johns Hopkins University
• Information provided by (Responsible Party): Johns Hopkins University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Opioid Use	Behavioral: Informational Sheet; Behavioral: DisposeRx Drug Disposal kit	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 499 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Masking Description: Outcome assessors are unaware of treatment assignment
• Primary Purpose: Other
• Official Title: Disposal Interventions for Safe Prescription Opioid Surplus Elimination: The DISPOSE Trial
• Actual Study Start Date: June 5, 2019
• Actual Primary Completion Date: August 14, 2019
• Actual Study Completion Date: August 14, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Number of participants using a safe drug disposal method for leftover prescription opioids [ Time Frame: Up to 6 weeks after prescription fill ]
   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)

Secondary Outcome Measures :

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

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

United States, Maryland

Johns Hopkins Hospital/Johns Hopkins Outpatient Center

Baltimore, Maryland, United States, 21287

Sponsors and Collaborators

Johns Hopkins University

Investigators

• Principal Investigator: Mark Bicket, MD; Johns Hopkins University

  Study Documents (Full-Text)

Documents provided by Johns Hopkins University:

Study Protocol and Statistical Analysis Plan  [PDF] August 13, 2019

More Information

Additional Information:

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 

Publications:

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. Review.

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT03855241
• Other Study ID Numbers: IRB00205030
• First Posted: February 26, 2019
• Last Update Posted: September 23, 2019
• Last Verified: September 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Johns Hopkins University:

Leftover opioids; Unused opioids; Safe prescription opioid disposal; Drug disposal