Environment Analysis Inside an Investigational Prescription Bottle
NCT ID: NCT03752411
Last Updated: 2023-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
96 participants
INTERVENTIONAL
2018-12-05
2023-11-05
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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Research Bottle
This group will have medication dispensed in a research bottle.
Research Bottle
The purpose of the study is to test a research prescription bottle that will monitor the physical environment inside the bottle.
Regular prescription Bottle
This group will have medication dispensed in a regular prescription bottle
Regular prescription Bottle
This will test if the research bottle changes behavior relative to the research bottle
Interventions
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Research Bottle
The purpose of the study is to test a research prescription bottle that will monitor the physical environment inside the bottle.
Regular prescription Bottle
This will test if the research bottle changes behavior relative to the research bottle
Eligibility Criteria
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Inclusion Criteria
* major source of pain is due to low back pain diagnosis
* prescribed only one type of opioid: hydrocodone 10mg/325 mg acetaminophen
* Last urine drug study was done between 6-12 months ago
* will have a return to clinic visit in 3 months
Exclusion Criteria
* use of intrathecal device
* use of spinal cord stimulator
* presence of pain due to cancer, chemotherapy, radiation treatment and/or cancer related surgery
* dementia
* illiteracy
18 Years
75 Years
ALL
No
Sponsors
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The University of Texas Medical Branch, Galveston
OTHER
Responsible Party
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Principal Investigators
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Denise Wilkes, MD-PhD
Role: STUDY_DIRECTOR
University of Texas
Locations
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University of Texas Medical Branch
Galveston, Texas, United States
Countries
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References
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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.
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.
Other Identifiers
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18-0022
Identifier Type: -
Identifier Source: org_study_id