Opioid UseDISPOSENCT03855241
Safely Disposing of Surplus Prescription Opioids
A study testing Informational Sheet and DisposeRx Drug Disposal kit in people with Opioid Use, run by Johns Hopkins University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use
- What is being tested?
- Informational Sheet and DisposeRx Drug Disposal kit
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 499 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jun 2019to 14 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Hospital/Johns Hopkins Outpatient Center
Baltimore, Maryland, 21287
About this study
Official title: Disposal Interventions for Safe Prescription Opioid Surplus Elimination: The DISPOSE Trial
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.
Read the 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.
- Conditions
- Opioid Use
- Being tested
- Informational Sheet, DisposeRx Drug Disposal kit
- Keywords
- Leftover opioids, Unused opioids, Safe prescription opioid disposal, Drug disposal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Informational SheetBehavioural
The informational sheet details how use opioid medicines safely, and lists ways to properly dispose of leftover opioids
DisposeRx Drug Disposal kitBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Informational Sheet |
| 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 Receives: Behavioral: Informational Sheet; Behavioral: DisposeRx Drug Disposal kit |
| No intervention | No intervention | Persons picking up an opioid prescription will receive no additional information or materials on disposal. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Up to 6 weeks after prescription fill
Secondary outcomes (3)
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
Measured: 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)
Measured: 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
Measured: Up to 6 weeks after prescription fill
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2019
- Study start5 Jun 2019
- Primary completion14 Aug 2019
- Study completion14 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Opioid UseStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 499 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark Bicket, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03855241
- Sponsor's protocol ID
- IRB00205030
- Acronym
- DISPOSE
- Status last verified
- Sep 2019
- First submitted
- 25 Feb 2019
- Last updated
- 23 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28768328Maughan 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.
PubMed 27663358Rose 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.
PubMed 26431852Bicket 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.
PubMed 33576394
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disposal Interventions for Safe Prescription Opioid Surplus Elimination: The DISPOSE Trial
- ClinicalTrials.gov ID
- NCT03855241
- Acronym / sponsor ID
- DISPOSE / IRB00205030
- Conditions
- Opioid Use
- Keywords
- Leftover opioids, Unused opioids, Safe prescription opioid disposal, Drug disposal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 499 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 5 Jun 2019 (actual)
- Primary completion
- 14 Aug 2019 (actual)
- Study completion
- 14 Aug 2019 (actual)
- First posted
- 26 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Informational Sheet | Active comparator | Behavioral: Informational SheetPersons picking up an opioid prescription will receive an informational sheet that describes how to properly dispose of leftover opioid medications |
| Drug Disposal Kit | Active comparator | Behavioral: Informational Sheet, Behavioral: DisposeRx Drug Disposal kitPersons 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Informational SheetThe informational sheet details how use opioid medicines safely, and lists ways to properly dispose of leftover opioids | Behavioural | Drug Disposal Kit, Informational Sheet |
| DisposeRx Drug Disposal kitDisposeRx 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. | Behavioural | Drug Disposal Kit |
Primary outcome
Number of participants using a safe drug disposal method for leftover prescription opioids
Time frame: Up to 6 weeks after prescription fill
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)
3 secondary outcomes
Number of participants using any drug disposal method for leftover prescription opioids
Time frame: Up to 6 weeks after prescription fill
Number of participants with safe storage of prescription opioids
Time frame: Up to 6 weeks after prescription fill
Number of participants who completed prescription opioid therapy
Time frame: Up to 6 weeks after prescription fill
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2019.
- Background: PubMed 28768328Bicket 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.
- Background: PubMed 27663358Maughan 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.
- Background: PubMed 26431852Rose 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.
- Derived from this study: PubMed 33576394Bicket 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 HealthLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Bicket, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Informational Sheet and DisposeRx Drug Disposal kit in people with Opioid Use, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants using a safe drug disposal method for leftover prescription opioids (time frame: Up to 6 weeks after prescription fill). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03855241, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2019.