The Use of Nomi Technology to Monitor Opioid Use
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 96
- Locations
- 1
- Primary Endpoint
- total nausea scale
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
- •illiteracy
Arms & Interventions
Research Bottle
This group will have medication dispensed in a research bottle.
Intervention: Research Bottle (Other)
Regular prescription Bottle
This group will have medication dispensed in a regular prescription bottle
Intervention: Regular prescription Bottle (Other)
Outcomes
Primary Outcomes
total nausea scale
Time Frame: day 90
On a scale of 0-3 where 0=no nausea, 1= mild, 2= moderate, and 3= severe
total medication dose
Time Frame: day 90
pain medication dose (mg)
total vomiting scale
Time Frame: day 90
On a scale of 0-3 where 0=no vomiting, 1= mild, 2= moderate, and 3= severe
total type of bowel movement
Time Frame: day 90
choose one of the following: hard, soft, loose
total Pain scale
Time Frame: day 90
On a scale of 0-10 where 0 is no pain and 10 is the worst pain ever felt.
overall satisfaction with pain control
Time Frame: day 90
0-10 scale where 0 is dissatisfied and 10 is very satisfied
total sedation scale
Time Frame: day 90
On a scale of 0-3 where 0=no sedation, 1= mild, 2= moderate, and 3= severe
total bowel movements
Time Frame: day 90
number of bowel movements (whole number)
Secondary Outcomes
- Barretts impulsivity questionnaire(day 90)
- opioid related behavior in treatment questionnaire(day 90)
- prescribed opioids difficulty scale(day 90)