Environment Analysis Inside an Investigational Prescription Bottle
Status
Conditions
Treatments
Details and patient eligibility
About
The purpose of the study is to test a research prescription bottle that will monitor the physical environment inside the bottle.
Full description
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- chronic pain > 3 months duration
- 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
- concurrent use of other opioids
- 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
Trial design
Primary purpose
Allocation
Interventional model
Masking
96 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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