Environment Analysis Inside an Investigational Prescription Bottle

Chronic Pain Clinical Trial

Official title:

The Use of Nomi Technology to Monitor Opioid Use

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03752411
• Other study ID #: 18-0022
• Status: Completed
• Phase: N/A
• Start date: December 5, 2018
• Est. completion date: November 5, 2023

Study information

• Verified date: November 2023
• Source: The University of Texas Medical Branch, Galveston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to test a research prescription bottle that will monitor the physical environment inside the bottle.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: November 5, 2023
• Est. primary completion date: November 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Other:
• 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

Locations

Country	Name	City	State
United States	University of Texas Medical Branch	Galveston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Medical Branch, Galveston

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	total medication dose	pain medication dose (mg)	day 90
Primary	total Pain scale	On a scale of 0-10 where 0 is no pain and 10 is the worst pain ever felt.	day 90
Primary	total nausea scale	On a scale of 0-3 where 0=no nausea, 1= mild, 2= moderate, and 3= severe	day 90
Primary	total vomiting scale	On a scale of 0-3 where 0=no vomiting, 1= mild, 2= moderate, and 3= severe	day 90
Primary	total sedation scale	On a scale of 0-3 where 0=no sedation, 1= mild, 2= moderate, and 3= severe	day 90
Primary	total bowel movements	number of bowel movements (whole number)	day 90
Primary	total type of bowel movement	choose one of the following: hard, soft, loose	day 90
Primary	overall satisfaction with pain control	0-10 scale where 0 is dissatisfied and 10 is very satisfied	day 90
Secondary	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
Secondary	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
Secondary	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