Environment Analysis Inside an Investigational Prescription Bottle

Study Overview
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Brief Summary
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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.

Detailed Description
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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 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.

Official Title
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The Use of Nomi Technology to Monitor Opioid Use

Conditions
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Chronic Pain

Intervention / Treatment
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* Other: Research Bottle
* Other: Regular prescription Bottle


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Research Bottle<br>This group will have medication dispensed in a research bottle. | Other: Research Bottle<br>* The purpose of the study is to test a research prescription bottle that will monitor the physical environment inside the bottle.<br>|
| Placebo Comparator: Regular prescription Bottle<br>This group will have medication dispensed in a regular prescription bottle | Other: Regular prescription Bottle<br>* This will test if the research bottle changes behavior relative to the research bottle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |