Safely Disposing of Surplus Prescription Opioids

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Opioid Use

Intervention / Treatment
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* Behavioral: Informational Sheet
* Behavioral: DisposeRx Drug Disposal kit


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Leftover opioids, Unused opioids, Safe prescription opioid disposal, Drug disposal