Chronic PainNCT03752411
Environment Analysis Inside an Investigational Prescription Bottle
A study testing Research Bottle and Regular prescription Bottle in people with Chronic Pain, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial summary
The purpose of the study is to test a research prescription bottle that will monitor the physical environment inside the bottle. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Research Bottle and Regular prescription Bottle
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2018to 5 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Medical Branch
Galveston, Texas, 77555
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Pain
- Being tested
- Research Bottle, Regular prescription Bottle
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Research BottleOther
The purpose of the study is to test a research prescription bottle that will monitor the physical environment inside the bottle.
Regular prescription BottleOther
This will test if the research bottle changes behavior relative to the research bottle
| Study group | Role | What they receive |
|---|---|---|
| Research Bottle | Experimental | This group will have medication dispensed in a research bottle. Receives: Other: Research Bottle |
| Regular prescription Bottle | Placebo comparator | This group will have medication dispensed in a regular prescription bottle Receives: Other: Regular prescription Bottle |
What is being measured
The primary outcome is the main question the study is designed to answer.
total medication dose
pain medication dose (mg)
Measured: day 90
total Pain scale
On a scale of 0-10 where 0 is no pain and 10 is the worst pain ever felt.
Measured: day 90
total nausea scale
On a scale of 0-3 where 0=no nausea, 1= mild, 2= moderate, and 3= severe
Measured: day 90
total vomiting scale
On a scale of 0-3 where 0=no vomiting, 1= mild, 2= moderate, and 3= severe
Measured: day 90
total sedation scale
On a scale of 0-3 where 0=no sedation, 1= mild, 2= moderate, and 3= severe
Measured: day 90
total bowel movements
number of bowel movements (whole number)
Measured: day 90
total type of bowel movement
choose one of the following: hard, soft, loose
Measured: day 90
overall satisfaction with pain control
0-10 scale where 0 is dissatisfied and 10 is very satisfied
Measured: day 90
Secondary outcomes (3)
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
Measured: 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
Measured: 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
Measured: day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2018
- Study start5 Dec 2018
- Primary completion5 Nov 2022
- Study completion5 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Denise Wilkes, MD-PhD, Study director, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03752411
- Sponsor's protocol ID
- 18-0022
- Status last verified
- Nov 2023
- First submitted
- 21 Nov 2018
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 25912277Houghton 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.
PubMed 38799276
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Nomi Technology to Monitor Opioid Use
- ClinicalTrials.gov ID
- NCT03752411
- Acronym / sponsor ID
- 18-0022
- Conditions
- Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- 5 Dec 2018 (actual)
- Primary completion
- 5 Nov 2022 (actual)
- Study completion
- 5 Nov 2023 (actual)
- First posted
- 26 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Research Bottle | Experimental | Other: Research BottleThis group will have medication dispensed in a research bottle. |
| Regular prescription Bottle | Placebo comparator | Other: Regular prescription BottleThis group will have medication dispensed in a regular prescription bottle |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Research BottleThe purpose of the study is to test a research prescription bottle that will monitor the physical environment inside the bottle. | Other | Research Bottle |
| Regular prescription BottleThis will test if the research bottle changes behavior relative to the research bottle | Other | Regular prescription Bottle |
Primary outcome
total medication dose
Time frame: day 90
pain medication dose (mg)
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.
total nausea scale
Time frame: day 90
On a scale of 0-3 where 0=no nausea, 1= mild, 2= moderate, and 3= severe
total vomiting scale
Time frame: day 90
On a scale of 0-3 where 0=no vomiting, 1= mild, 2= moderate, and 3= severe
total sedation scale
Time frame: day 90
On a scale of 0-3 where 0=no sedation, 1= mild, 2= moderate, and 3= severe
total bowel movements
Time frame: day 90
number of bowel movements (whole number)
total type of bowel movement
Time frame: day 90
choose one of the following: hard, soft, loose
overall satisfaction with pain control
Time frame: day 90
0-10 scale where 0 is dissatisfied and 10 is very satisfied
3 secondary outcomes
opioid related behavior in treatment questionnaire
Time frame: day 90
prescribed opioids difficulty scale
Time frame: day 90
Barretts impulsivity questionnaire
Time frame: day 90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Background: PubMed 25912277Robinson-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.
- Derived from this study: PubMed 38799276Houghton 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.
- Individual participant dataSharing planned: No
Related trials for Chronic Pain
Not yet recruiting
Digital Use, 24-Hour Movement Behaviors, and Myofascial Release in University Students With Neck Pain
Forward Head Posture, Chronic Nonspecific Neck Pain
Recruiting
Effects of Virtual Reality Exergames Versus Spinal Manipulation in Chronic Nonspecific Low Back Pain
Chronic Nonspecific Low-back Pain, CNSLBP
Recruiting
Dietary Intervention for Migraine Relief
Migraine
Active, not recruiting
Healing Opioid Misuse and Pain Through Engagement (HOPE) Trial
Opioid Use Disorder, Chronic Pain
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Denise Wilkes, MD-PhD study director
University of Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Research Bottle and Regular prescription Bottle in people with Chronic Pain, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total medication dose (time frame: day 90). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03752411, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023; AzTrials last refreshed its copy on 2 Nov 2026.