NCT03752411

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable chronic-pain

Timeline
Completed

Started Dec 2018

Longer than P75 for not_applicable chronic-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 21, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 26, 2018

Completed
9 days until next milestone

Study Start

First participant enrolled

December 5, 2018

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 5, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 5, 2023

Completed
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

3.9 years

First QC Date

November 21, 2018

Last Update Submit

November 27, 2023

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (8)

  • 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 Outcomes (3)

  • opioid related behavior in treatment questionnaire

    day 90

  • prescribed opioids difficulty scale

    day 90

  • Barretts impulsivity questionnaire

    day 90

Study Arms (2)

Research Bottle

EXPERIMENTAL

This group will have medication dispensed in a research bottle.

Other: Research Bottle

Regular prescription Bottle

PLACEBO COMPARATOR

This group will have medication dispensed in a regular prescription bottle

Other: Regular prescription Bottle

Interventions

Research BottleOTHER

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

Research Bottle
Regular prescription BottleOTHER

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

Regular prescription Bottle

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

Related Publications (2)

  • 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.

    PMID: 25912277BACKGROUND

  • Houghton DC, Merritt CR, Miller SN, Mitchell JM, Parker D, Hommel JD, Cunningham KA, Wilkes DM. Electronic Real-Time Monitoring Reveals Limited Adherence to Long-Term Opioid Prescriptions in Pain Patients. J Pain Res. 2024 May 21;17:1815-1827. doi: 10.2147/JPR.S436898. eCollection 2024.

    PMID: 38799276DERIVED

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Denise Wilkes, MD-PhD

    University of Texas

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2018

First Posted

November 26, 2018

Study Start

December 5, 2018

Primary Completion

November 5, 2022

Study Completion

November 5, 2023

Last Updated

November 29, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)