Environment Analysis Inside an Investigational Prescription Bottle

• ClinicalTrials.gov Identifier: NCT03752411
• Recruitment Status: Recruiting
• First Posted: November 26, 2018
• Last Update Posted: September 22, 2021
• Sponsor: The University of Texas Medical Branch, Galveston
• Information provided by (Responsible Party): The University of Texas Medical Branch, Galveston

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.

Condition or disease	Intervention/treatment	Phase
Chronic Pain	Other: Research Bottle; Other: Regular prescription Bottle	Not Applicable

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 (Clinical Trial)
• Estimated Enrollment: 96 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Other
• Official Title: The Use of Nomi Technology to Monitor Opioid Use
• Actual Study Start Date: December 5, 2018
• Estimated Primary Completion Date: May 5, 2023
• Estimated Study Completion Date: November 5, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. total medication dose [ Time Frame: day 90 ]
   pain medication dose (mg)
2. 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.
3. total nausea scale [ Time Frame: day 90 ]
   On a scale of 0-3 where 0=no nausea, 1= mild, 2= moderate, and 3= severe
4. total vomiting scale [ Time Frame: day 90 ]
   On a scale of 0-3 where 0=no vomiting, 1= mild, 2= moderate, and 3= severe
5. total sedation scale [ Time Frame: day 90 ]
   On a scale of 0-3 where 0=no sedation, 1= mild, 2= moderate, and 3= severe
6. total bowel movements [ Time Frame: day 90 ]
   number of bowel movements (whole number)
7. total type of bowel movement [ Time Frame: day 90 ]
   choose one of the following: hard, soft, loose
8. overall satisfaction with pain control [ Time Frame: day 90 ]
   0-10 scale where 0 is dissatisfied and 10 is very satisfied

Secondary Outcome Measures :

1. opioid related behavior in treatment questionnaire [ Time Frame: day 90 ]
   Measures opioid misuse score (number 0-40) where 0-10 is low misuse, 11-30 is moderate misuse and 31-40 is high misuse
2. prescribed opioids difficulty scale [ Time Frame: day 90 ]
   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
3. Barretts impulsivity questionnaire [ Time Frame: day 90 ]
   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

Eligibility Criteria

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

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

Contacts and Locations

Contacts

Contact: Maria Garcia, MS; 409-789-2308; mdgarcia@utmb.edu

Contact: Denise Wilkes, MD-PhD; 832-646-2126; dwilkes@utmb.edu

Locations

United States, Texas

University of Texas Medical Branch; Recruiting

Galveston, Texas, United States, 77555

Contact: Denise Wilkes, MD 409-772-1221

Sponsors and Collaborators

The University of Texas Medical Branch, Galveston

Investigators

• Study Director: Denise Wilkes, MD-PhD; University of Texas

More Information

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.

• Responsible Party: The University of Texas Medical Branch, Galveston
• ClinicalTrials.gov Identifier: NCT03752411
• Other Study ID Numbers: 18-0022
• First Posted: November 26, 2018
• Last Update Posted: September 22, 2021
• Last Verified: September 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Additional relevant MeSH terms:

Chronic Pain; Pain; Neurologic Manifestations