Chronic Pain
Conditions
Brief summary
The purpose of the study is to test a research prescription bottle that will monitor the physical environment inside the bottle.
Detailed 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.
Interventions
OTHERResearch Bottle
The purpose of the study is to test a research prescription bottle that will monitor the physical environment inside the bottle.
OTHERRegular prescription Bottle
This will test if the research bottle changes behavior relative to the research bottle
Sponsors
The University of Texas Medical Branch, Galveston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| total bowel movements | day 90 | number of bowel movements (whole number) |
| total type of bowel movement | day 90 | choose one of the following: hard, soft, loose |
| overall satisfaction with pain control | day 90 | 0-10 scale where 0 is dissatisfied and 10 is very satisfied |
| total sedation scale | day 90 | On a scale of 0-3 where 0=no sedation, 1= mild, 2= moderate, and 3= severe |
| total medication dose | day 90 | pain medication dose (mg) |
| total Pain scale | day 90 | On a scale of 0-10 where 0 is no pain and 10 is the worst pain ever felt. |
| total nausea scale | day 90 | On a scale of 0-3 where 0=no nausea, 1= mild, 2= moderate, and 3= severe |
| total vomiting scale | day 90 | On a scale of 0-3 where 0=no vomiting, 1= mild, 2= moderate, and 3= severe |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| opioid related behavior in treatment questionnaire | day 90 | Measures opioid misuse score (number 0-40) where 0-10 is low misuse, 11-30 is moderate misuse and 31-40 is high misuse |
| prescribed opioids difficulty scale | day 90 | 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 |
| Barretts impulsivity questionnaire | day 90 | 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 |
Countries
United States
Outcome results
None listed