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The purpose of the study is to test a research prescription bottle that will monitor the physical environment inside the bottle.
The purpose of the study is to test a research prescription bottle that will monitor the physical environment inside the bottle. The participant will be asked to keep the medication in the bottle and to remove each pill immediately before taking it.
The participant will not store medications in pill organizers, other pill bottles, pockets, purses, etc. The participant will keep a record of when the participant removes a pill from the bottle and takes it. Certain aspects of this study will be withheld from the participant to preserve the integrity of the study. This information will be revealed at the conclusion of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Research Bottle | Experimental | This group will have medication dispensed in a research bottle. |
|
| Regular prescription Bottle | Placebo Comparator | This group will have medication dispensed in a regular prescription bottle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Research Bottle | Other | The purpose of the study is to test a research prescription bottle that will monitor the physical environment inside the bottle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| total medication dose | pain medication dose (mg) | day 90 |
| total Pain scale | On a scale of 0-10 where 0 is no pain and 10 is the worst pain ever felt. | day 90 |
| total nausea scale | On a scale of 0-3 where 0=no nausea, 1= mild, 2= moderate, and 3= severe | day 90 |
| total vomiting scale | On a scale of 0-3 where 0=no vomiting, 1= mild, 2= moderate, and 3= severe | day 90 |
| total sedation scale | On a scale of 0-3 where 0=no sedation, 1= mild, 2= moderate, and 3= severe | day 90 |
| total bowel movements | number of bowel movements (whole number) | day 90 |
| total type of bowel movement | choose one of the following: hard, soft, loose | day 90 |
| overall satisfaction with pain control | 0-10 scale where 0 is dissatisfied and 10 is very satisfied | day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| opioid related behavior in treatment questionnaire | Measures opioid misuse score (number 0-40) where 0-10 is low misuse, 11-30 is moderate misuse and 31-40 is high misuse | day 90 |
| prescribed opioids difficulty scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Denise Wilkes, MD-PhD | University of Texas | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Medical Branch | Galveston | Texas | 77555 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25912277 | Background | Robinson-Papp J, George MC, Wongmek A, Nmashie A, Merlin JS, Ali Y, Epstein L, Green M, Serban S, Sheth P, Simpson DM. The Quantitative Analgesic Questionnaire: A Tool to Capture Patient-Reported Chronic Pain Medication Use. J Pain Symptom Manage. 2015 Sep;50(3):381-6. doi: 10.1016/j.jpainsymman.2015.03.013. Epub 2015 Apr 23. | |
| 38799276 |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Regular prescription Bottle | Other | This will test if the research bottle changes behavior relative to the research bottle |
|
measures opioid management score (number 0-32) where 0-10 is low difficulty, 11-21 is moderate difficulty and 22-32 is high levels of difficulty
| day 90 |
| Barretts impulsivity questionnaire | Measures impulsivity behavior core (number 0-120) where 0-40 is low levels of impulsivity, 41-80 is moderate levels of impulsivity, and 81-120 is high levels of impulsivity | day 90 |
| Houghton DC, Merritt CR, Miller SN, Mitchell JM, Parker D, Hommel JD, Cunningham KA, Wilkes DM. Electronic Real-Time Monitoring Reveals Limited Adherence to Long-Term Opioid Prescriptions in Pain Patients. J Pain Res. 2024 May 21;17:1815-1827. doi: 10.2147/JPR.S436898. eCollection 2024. |