Clinical trial NCT03855241: Safely Disposing of Surplus Prescription Opioids
Official title: Disposal Interventions for Safe Prescription Opioid Surplus Elimination: The DISPOSE Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Use
Keywords: Leftover opioids
Unused opioids
Safe prescription opioid disposal
Drug disposal
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2019-02-26
Enrollment: 499
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Eligibility 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

Primary outcomes:
measure: Number of participants using a safe drug disposal method for leftover prescription opioids
timeFrame: Up to 6 weeks after prescription fill
Secondary outcomes:
measure: Number of participants using any drug disposal method for leftover prescription opioids
timeFrame: Up to 6 weeks after prescription fill
measure: Number of participants with safe storage of prescription opioids
timeFrame: Up to 6 weeks after prescription fill
measure: Number of participants who completed prescription opioid therapy
timeFrame: Up to 6 weeks after prescription fill
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital/Johns Hopkins Outpatient Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Mark Bicket, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
citation: 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.