Opioid UseNCT04113252
Impact of Coaching Patients on Pain Control With and Without Financial Incentivization
A study testing Possible Incentive for Tablet Return, Incentive for Completed Diary and Coaching in people with Opioid Use, run by Wake Forest University Health Sciences.
Trial summary
Opioids are commonly prescribed pain medications, but they can lead to addiction. The study team is trying to determine if providing someone with an incentive (money in the form of a Visa gift card) to use less pain medications will result in study participants actually using fewer pain tablets than allowed by their… Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Opioid Use
- What is being tested?
- Possible Incentive for Tablet Return, Incentive for Completed Diary and Coaching
- 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
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2022to Aug 2022
- 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 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients suffering from a burn injury of one or both hands/upper extremities
- Patients staying less than 2 midnights after date of injury or presenting for first visit to the clinic 4 or less days after injury
- Patients able to self-administer their oxycodone.
- Aged 18-89 years old
Who cannot join
- No burns on either hand or upper extremity
- Patients suffering chemical or electrical burns
- Patients with other traumatic injuries for which they might require opioids/pain treatment
- Patients taking opioids prior to injury
- Patients who are discharged with prescriptions other than oxycodone with a dosage of 5 milligrams by mouth every six hours as needed
About this study
Official title: The Economy of Pain: A Pilot Study of the Impact of an Opioid Buyback Program
Opioids are commonly prescribed pain medications, but they can lead to addiction. The study team is trying to determine if providing someone with an incentive (money in the form of a Visa gift card) to use less pain medications will result in study participants actually using fewer pain tablets than allowed by their health care provider. The study team also wants to know if providing the incentive (the Visa gift card alone) works the same as the incentive (the Visa gift card) plus providing additional information about addiction and alternative pain management.
Read the detailed description
Study participants will receive the standard of care for pain management at discharge. If study participants were not hospitalized at discharge, the study team will begin that standard of pain management at the participant's first outpatient clinic visit. Study participants will be randomized to 1 of 3 groups. All groups will receive a gift card if participants return the completed medication diary to the study team.
- Group 1 will complete a medication diary. Also, group 1 will be encouraged to return any unused tablets to the study clinic.
- Group 2 will be asked to complete a medication diary. Group 2 will also have a 50/50 chance of receiving money for each unused opioid tablet returned to the study clinic.
- Group 3 will be the same as group 2 except in addition, they will be given a coaching session about the use of pain medication and a simple way that may help participants use less opioid pain medication.
- Conditions
- Opioid Use
- Being tested
- Possible Incentive for Tablet Return, Incentive for Completed Diary, Coaching
- Keywords
- opioid buyback, opioid misuse prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Possible Incentive for Tablet ReturnOther
Subjects who return completed diary will have the possibility to receive money for returned opioid tablets.
Incentive for Completed DiaryOther
Subjects who return completed diary will receive a gift card.
CoachingBehavioural
Subjects will receive coaching prior to starting pain medication.
| Study group | Role | What they receive |
|---|---|---|
| Group 1--Diary and Possible Opioid Return Incentive | Experimental | Participants in this arm will be given incentives upon return of completed diary and will have the possibility to earn incentives for returning any leftover tablets to the study team. Receives: Other: Possible Incentive for Tablet Return; Other: Incentive for Completed Diary |
| Group 2--Diary, Coaching, Possible Opioid Return Incentive | Experimental | Participants in this arm will be given coaching. They will also be given incentives upon return of completed diary and will have the possibility to earn incentives for returning any leftover tablets to the study team. Receives: Other: Possible Incentive for Tablet Return; Other: Incentive for Completed Diary; Behavioral: Coaching |
| Group 3--Diary and coaching | Experimental | Participants in this arm will be given coaching. They will also be given incentives upon return of completed diary. Receives: Other: Incentive for Completed Diary; Behavioral: Coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean number of opioid tablets used daily
Measured: up through two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2019
- Study startMay 2022 (estimated)
- Primary completionAug 2022 (estimated)
- Study completionAug 2022 (estimated)
Why it stopped: Too difficult to see patients in required time intervals.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid UseStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John K Bailey, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04113252
- Sponsor's protocol ID
- IRB00058073
- Status last verified
- Aug 2021
- First submitted
- 1 Oct 2019
- Last updated
- 12 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Economy of Pain: A Pilot Study of the Impact of an Opioid Buyback Program
- ClinicalTrials.gov ID
- NCT04113252
- Acronym / sponsor ID
- IRB00058073
- Conditions
- Opioid Use
- Keywords
- opioid buyback, opioid misuse prevention
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Too difficult to see patients in required time intervals.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- May 2022 (estimated)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 2 Oct 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.
Opioids are commonly prescribed pain medications, but they can lead to addiction. The study team is trying to determine if providing someone with an incentive (money in the form of a Visa gift card) to use less pain medications will result in study participants actually using fewer pain tablets than allowed by their health care provider. The study team also wants to know if providing the incentive (the Visa gift card alone) works the same as the incentive (the Visa gift card) plus providing additional information about addiction and alternative pain management.
Detailed description
Study participants will receive the standard of care for pain management at discharge. If study participants were not hospitalized at discharge, the study team will begin that standard of pain management at the participant's first outpatient clinic visit. Study participants will be randomized to 1 of 3 groups. All groups will receive a gift card if participants return the completed medication diary to the study team.
- Group 1 will complete a medication diary. Also, group 1 will be encouraged to return any unused tablets to the study clinic.
- Group 2 will be asked to complete a medication diary. Group 2 will also have a 50/50 chance of receiving money for each unused opioid tablet returned to the study clinic.
- Group 3 will be the same as group 2 except in addition, they will be given a coaching session about the use of pain medication and a simple way that may help participants use less opioid pain medication.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1--Diary and Possible Opioid Return Incentive | Experimental | Other: Possible Incentive for Tablet Return, Other: Incentive for Completed DiaryParticipants in this arm will be given incentives upon return of completed diary and will have the possibility to earn incentives for returning any leftover tablets to the study team. |
| Group 2--Diary, Coaching, Possible Opioid Return Incentive | Experimental | Other: Possible Incentive for Tablet Return, Other: Incentive for Completed Diary, Behavioral: CoachingParticipants in this arm will be given coaching. They will also be given incentives upon return of completed diary and will have the possibility to earn incentives for returning any leftover tablets to the study team. |
| Group 3--Diary and coaching | Experimental | Other: Incentive for Completed Diary, Behavioral: CoachingParticipants in this arm will be given coaching. They will also be given incentives upon return of completed diary. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients suffering from a burn injury of one or both hands/upper extremities
- Patients staying less than 2 midnights after date of injury or presenting for first visit to the clinic 4 or less days after injury
- Patients able to self-administer their oxycodone.
- Aged 18-89 years old
Key exclusion criteria (5 listed)
- No burns on either hand or upper extremity
- Patients suffering chemical or electrical burns
- Patients with other traumatic injuries for which they might require opioids/pain treatment
- Patients taking opioids prior to injury
- Patients who are discharged with prescriptions other than oxycodone with a dosage of 5 milligrams by mouth every six hours as needed
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 |
|---|---|---|
| Possible Incentive for Tablet ReturnSubjects who return completed diary will have the possibility to receive money for returned opioid tablets. | Other | Group 1--Diary and Possible Opioid Return Incentive, Group 2--Diary, Coaching, Possible Opioid Return Incentive |
| Incentive for Completed DiarySubjects who return completed diary will receive a gift card. | Other | Group 1--Diary and Possible Opioid Return Incentive, Group 2--Diary, Coaching, Possible Opioid Return Incentive, Group 3--Diary and coaching |
| CoachingSubjects will receive coaching prior to starting pain medication. | Behavioural | Group 2--Diary, Coaching, Possible Opioid Return Incentive, Group 3--Diary and coaching |
Primary outcome
Mean number of opioid tablets used daily
Time frame: up through two weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2022.
- Individual participant dataSharing planned: Yes
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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.
John K Bailey, MD principal investigator
Wake Forest University Health Sciences
Questions about this trial
What is this clinical trial studying?
A study testing Possible Incentive for Tablet Return, Incentive for Completed Diary and Coaching in people with Opioid Use, run by Wake Forest University Health Sciences.
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 5 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: withdrawn, as of the sponsor's last update on 12 May 2022. 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 was withdrawn before enrolling participants, so there are no results.
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?
Mean number of opioid tablets used daily (time frame: up through two weeks). 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 12 May 2022.