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Environment Analysis Inside an Investigational Prescription Bottle

Primary Purpose

Chronic Pain

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Research Bottle
Regular prescription Bottle
Sponsored by
The University of Texas Medical Branch, Galveston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Pain

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Texas Medical Branch

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Research Bottle

Regular prescription Bottle

Arm Description

This group will have medication dispensed in a research bottle.

This group will have medication dispensed in a regular prescription bottle

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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

Full Information

First Posted
November 21, 2018
Last Updated
March 20, 2023
Sponsor
The University of Texas Medical Branch, Galveston
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1. Study Identification

Unique Protocol Identification Number
NCT03752411
Brief Title
Environment Analysis Inside an Investigational Prescription Bottle
Official Title
The Use of Nomi Technology to Monitor Opioid Use
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 5, 2018 (Actual)
Primary Completion Date
November 5, 2022 (Actual)
Study Completion Date
November 5, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Medical Branch, Galveston

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Research Bottle
Arm Type
Experimental
Arm Description
This group will have medication dispensed in a research bottle.
Arm Title
Regular prescription Bottle
Arm Type
Placebo Comparator
Arm Description
This group will have medication dispensed in a regular prescription bottle
Intervention Type
Other
Intervention Name(s)
Research Bottle
Intervention Description
The purpose of the study is to test a research prescription bottle that will monitor the physical environment inside the bottle.
Intervention Type
Other
Intervention Name(s)
Regular prescription Bottle
Intervention Description
This will test if the research bottle changes behavior relative to the research bottle
Primary Outcome Measure Information:
Title
total medication dose
Description
pain medication dose (mg)
Time Frame
day 90
Title
total Pain scale
Description
On a scale of 0-10 where 0 is no pain and 10 is the worst pain ever felt.
Time Frame
day 90
Title
total nausea scale
Description
On a scale of 0-3 where 0=no nausea, 1= mild, 2= moderate, and 3= severe
Time Frame
day 90
Title
total vomiting scale
Description
On a scale of 0-3 where 0=no vomiting, 1= mild, 2= moderate, and 3= severe
Time Frame
day 90
Title
total sedation scale
Description
On a scale of 0-3 where 0=no sedation, 1= mild, 2= moderate, and 3= severe
Time Frame
day 90
Title
total bowel movements
Description
number of bowel movements (whole number)
Time Frame
day 90
Title
total type of bowel movement
Description
choose one of the following: hard, soft, loose
Time Frame
day 90
Title
overall satisfaction with pain control
Description
0-10 scale where 0 is dissatisfied and 10 is very satisfied
Time Frame
day 90
Secondary Outcome Measure Information:
Title
opioid related behavior in treatment questionnaire
Description
Measures opioid misuse score (number 0-40) where 0-10 is low misuse, 11-30 is moderate misuse and 31-40 is high misuse
Time Frame
day 90
Title
prescribed opioids difficulty scale
Description
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
Time Frame
day 90
Title
Barretts impulsivity questionnaire
Description
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
Time Frame
day 90

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Denise Wilkes, MD-PhD
Organizational Affiliation
University of Texas
Official's Role
Study Director
Facility Information:
Facility Name
University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25912277
Citation
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.
Results Reference
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Environment Analysis Inside an Investigational Prescription Bottle

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