Safely Disposing of Surplus Prescription Opioids

NCT ID: NCT03855241

Last Updated: 2019-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

499 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-05

Study Completion Date

2019-08-14

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.

Conditions

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Opioid Use

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors
Outcome assessors are unaware of treatment assignment

Study Groups

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Informational Sheet

Persons picking up an opioid prescription will receive an informational sheet that describes how to properly dispose of leftover opioid medications

Group Type ACTIVE_COMPARATOR

Informational Sheet

Intervention Type BEHAVIORAL

The informational sheet details how use opioid medicines safely, and lists ways to properly dispose of leftover opioids

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

Group Type ACTIVE_COMPARATOR

Informational Sheet

Intervention Type BEHAVIORAL

The informational sheet details how use opioid medicines safely, and lists ways to properly dispose of leftover opioids

DisposeRx Drug Disposal kit

Intervention Type 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.

No intervention

Persons picking up an opioid prescription will receive no additional information or materials on disposal.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Informational Sheet

The informational sheet details how use opioid medicines safely, and lists ways to properly dispose of leftover opioids

Intervention Type 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.

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mark Bicket, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Johns Hopkins Hospital/Johns Hopkins Outpatient Center

Baltimore, Maryland, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 28768328 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27663358 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26431852 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33576394 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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https://www.samhsa.gov/data/sites/default/files/cbhsq-reports/NSDUHFFR2017/NSDUHFFR2017.htm

Key Substance Use and Mental Health Indicators in the United States: Results from the 2017 National Survey on Drug Use and Health

Other Identifiers

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IRB00205030

Identifier Type: -

Identifier Source: org_study_id

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