Safely Disposing of Surplus Prescription Opioids

Opioid Use Clinical Trial

— DISPOSE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03855241
• Other study ID #: IRB00205030
• Status: Completed
• Phase: N/A
• Start date: June 5, 2019
• Est. completion date: August 14, 2019

Study information

• Verified date: September 2019
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 499
• Est. completion date: August 14, 2019
• Est. primary completion date: August 14, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Opioid Use

Intervention

Behavioral:
• Informational Sheet
The informational sheet details how use opioid medicines safely, and lists ways to properly dispose of leftover opioids
• 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.

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital/Johns Hopkins Outpatient Center	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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

External Links

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