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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
|
| No intervention | No Intervention | Persons picking up an opioid prescription will receive no additional information or materials on disposal. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Informational Sheet | Behavioral | The informational sheet details how use opioid medicines safely, and lists ways to properly dispose of leftover opioids |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Bicket, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Hospital/Johns Hopkins Outpatient Center | Baltimore | Maryland | 21287 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28768328 | Background | 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. | |
| 27663358 | Background | 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. |
| Label | URL |
|---|---|
| Provisional Drug Overdose Death Counts | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 13, 2019 | Aug 13, 2019 | Prot_SAP_000.pdf |
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Outcome assessors are unaware of treatment assignment
| DisposeRx Drug Disposal kit | Behavioral | 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. |
|
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 |
| 26431852 | Background | 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. |
| 33576394 | Derived | 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. |
| Key Substance Use and Mental Health Indicators in the United States: Results from the 2017 National Survey on Drug Use and Health | View source |