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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04113252
Other study ID # IRB00058073
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date May 2022
Est. completion date August 2022

Study information

Verified date August 2021
Source Wake Forest University Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date August 2022
Est. primary completion date August 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 89 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Possible Incentive for Tablet Return
Subjects who return completed diary will have the possibility to receive money for returned opioid tablets.
Incentive for Completed Diary
Subjects who return completed diary will receive a gift card.
Behavioral:
Coaching
Subjects will receive coaching prior to starting pain medication.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Wake Forest University Health Sciences

Outcome

Type Measure Description Time frame Safety issue
Primary Mean number of opioid tablets used daily up through two weeks
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