Environment Analysis Inside an Investigational Prescription Bottle

The Use of Nomi Technology to Monitor Opioid Use

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

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Other: Research Bottle; Other: Regular prescription 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 Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Galveston, Texas, United States, 77555
      • University of Texas Medical Branch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The University of Texas Medical Branch, Galveston
• Investigators: Study Director: Denise Wilkes, MD-PhD, University of Texas

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2018
• Primary Completion (Actual): November 5, 2022
• Study Completion (Actual): November 5, 2023

Study Registration Dates

• First Submitted: November 21, 2018
• First Submitted That Met QC Criteria: November 21, 2018
• First Posted (Actual): November 26, 2018

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: 18-0022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes