Opioid Use DisordersNCT02814305
Opioid Analgesic Use and Disposal Following Outpatient Dental Surgery
A study testing Financial and Educational in people with Opioid Use Disorders and Tooth Extraction Status Nos, run by University of Pennsylvania.
Trial summary
Background: Overdose deaths from prescription opioid analgesics quadrupled from 4,000 cases to nearly 17,000 cases annually during 1999-2011. Most people who misuse or abuse prescription opioids obtain these pills from friends or family members who have surplus medication left over from prior prescriptions. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Opioid Use Disorders, Tooth Extraction Status Nos
- What is being tested?
- Financial and Educational
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Sep 2015
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Non-institutionalized
Who cannot join
- pregnancy
- a history of opioid analgesic misuse/abuse
- ongoing participation in other clinical research
- or daily use of opioid analgesics in the week prior to surgery
About this study
Background: Overdose deaths from prescription opioid analgesics quadrupled from 4,000 cases to nearly 17,000 cases annually during 1999-2011. Most people who misuse or abuse prescription opioids obtain these pills from friends or family members who have surplus medication left over from prior prescriptions. There is little published data on surplus opioid analgesics remaining after patients recover from painful procedures. Even less is known about patients' willingness to dispose of these leftover pills.
Aims: 1) Measure the impact of a risk education intervention and a financial incentive intervention on patients' willingness to dispose of surplus opioids left over after outpatient dental surgery. 2) Measure the number and proportion of opioid pills left unused after outpatient dental surgery.
Methods: The study will be a pilot randomized controlled trial. Adult patients at the Penn Dental Care Center will be enrolled prior to elective outpatient dental surgery. Patients will be randomized to a control group, an educational intervention, or a financial incentive intervention. The primary outcome of the trial is the proportion of patients in each arm that express willingness to return their unused opioids. Secondary outcomes include patient use of prescribed opioids and their number of unused pills. These outcomes will be measured using novel text-message based data collection software that patients will interact with using a web-enabled cellular telephone or tablet.
- Conditions
- Opioid Use Disorders, Tooth Extraction Status Nos
- Being tested
- Financial, Educational
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FinancialBehavioural
Patient receives information on a program that may offer a financial benefit for disposing of unused opioid analgesics at a pharmacy
EducationalBehavioural
Patient watches a video featuring narrative vignettes of patients who developed opioid dependence or abuse after using opioids postoperatively
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Patient receives neither educational nor financial interventions |
| Financial intervention only | Experimental | Patient receives financial (pharmacy offer) intervention only Receives: Behavioral: Financial |
| Educational intervention only | Experimental | Patient receives educational (narrative) intervention only Receives: Behavioral: Educational |
| Both interventions | Experimental | Patient receives both educational and financial interventions Receives: Behavioral: Financial; Behavioral: Educational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unused opioids
Number of opioids reported unused by the patient after postoperative day 21
Measured: 21 days after surgery
Secondary outcomes (1)
Intent to dispose of opioids
Patient reports intent to dispose of leftover opioids during follow-up interview or by calling study hotline
Measured: Any time during the 21-day data collection period or during the follow-up interview on (or shortly after) postoperative day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2016 (estimated)
- Study startMar 2015
- Primary completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisordersStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02814305
- Sponsor's protocol ID
- 821823
- Status last verified
- Jun 2016
- First submitted
- 16 Jun 2016
- Last updated
- 27 Jun 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opioid Analgesic Use and Disposal Following Outpatient Dental Surgery
- ClinicalTrials.gov ID
- NCT02814305
- Acronym / sponsor ID
- 821823
- Conditions
- Opioid Use Disorders, Tooth Extraction Status Nos
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Sep 2015 (actual)
- First posted
- 27 Jun 2016 (estimated)
- 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.
Background: Overdose deaths from prescription opioid analgesics quadrupled from 4,000 cases to nearly 17,000 cases annually during 1999-2011. Most people who misuse or abuse prescription opioids obtain these pills from friends or family members who have surplus medication left over from prior prescriptions. There is little published data on surplus opioid analgesics remaining after patients recover from painful procedures. Even less is known about patients' willingness to dispose of these leftover pills.
Aims: 1) Measure the impact of a risk education intervention and a financial incentive intervention on patients' willingness to dispose of surplus opioids left over after outpatient dental surgery. 2) Measure the number and proportion of opioid pills left unused after outpatient dental surgery.
Methods: The study will be a pilot randomized controlled trial. Adult patients at the Penn Dental Care Center will be enrolled prior to elective outpatient dental surgery. Patients will be randomized to a control group, an educational intervention, or a financial incentive intervention. The primary outcome of the trial is the proportion of patients in each arm that express willingness to return their unused opioids. Secondary outcomes include patient use of prescribed opioids and their number of unused pills. These outcomes will be measured using novel text-message based data collection software that patients will interact with using a web-enabled cellular telephone or tablet.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Patient receives neither educational nor financial interventions |
| Financial intervention only | Experimental | Behavioral: FinancialPatient receives financial (pharmacy offer) intervention only |
| Educational intervention only | Experimental | Behavioral: EducationalPatient receives educational (narrative) intervention only |
| Both interventions | Experimental | Behavioral: Financial, Behavioral: EducationalPatient receives both educational and financial interventions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Non-institutionalized
Key exclusion criteria (4 listed)
- pregnancy
- a history of opioid analgesic misuse/abuse
- ongoing participation in other clinical research
- or daily use of opioid analgesics in the week prior to surgery
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 |
|---|---|---|
| FinancialPatient receives information on a program that may offer a financial benefit for disposing of unused opioid analgesics at a pharmacy | Behavioural | Both interventions, Financial intervention only |
| EducationalPatient watches a video featuring narrative vignettes of patients who developed opioid dependence or abuse after using opioids postoperatively | Behavioural | Both interventions, Educational intervention only |
Primary outcome
Unused opioids
Time frame: 21 days after surgery
Number of opioids reported unused by the patient after postoperative day 21
1 secondary outcome
Intent to dispose of opioids
Time frame: Any time during the 21-day data collection period or during the follow-up interview on (or shortly after) postoperative day 21
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 27 Jun 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Financial and Educational in people with Opioid Use Disorders and Tooth Extraction Status Nos, run by University of Pennsylvania.
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 1 inclusion and 4 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 27 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Unused opioids (time frame: 21 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jun 2016.