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Completed

NCT Number: NCT03752411

Environment Analysis Inside an Investigational Prescription Bottle

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

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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Texas Medical Branch

Galveston, Texas, 77555, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Research Bottle

Other

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

Regular prescription Bottle

Other

This will test if the research bottle changes behavior relative to the research bottle

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

The University of Texas Medical Branch, Galveston

Other

Registry information

Official study title

The Use of Nomi Technology to Monitor Opioid Use

Important dates

Study start
2018
Primary completion
2022
Study completion
2023
First posted
Nov 26, 2018
Registry last updated
Nov 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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