Opioid MisuseNCT05461196
Decreasing Opioid Misuse and Habit-forming Behaviors Following Prescription in Patients Undergoing Cesarean Section
A study testing CPMRx in people with Opioid Misuse, run by Jessica Morgan at 1 site in United States.
Trial summary
Background: Cesarean delivery is one of the most common obstetric procedures experienced among women who are pregnant.1 Women with Cesarean deliveries have a higher rate of peripartum opioid prescriptions and persistent opioid use compared to those with vaginal deliveries.2 Since 2002, prescription opioid use and… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Opioid Misuse
- What is being tested?
- CPMRx
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 12 May 2021to 1 Aug 2022
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patient is a female adult between the ages of 18-50 years
- Patient is undergoing cesarean section procedure at Temple University Hospital
- Patient is able and willing to provide informed consent
- Patient has insurance that will cover cost of prescription drugs or is able to pay out-of-pocket
- Patient has their own smart mobile phone (>80% of the target population owns a mobile phone)
Who cannot join
- Patient with contraindications to opioid medications, NSAIDs, or acetaminophen (including but not limited to allergy, intolerance, inability to swallow pills, etc.)
- Patient is unable to take tablets or tolerate oral intake
- Patient has a diagnosis of acute or chronic pain disorder
- Patient has used an opioid within the past 12 months
- Patient is non-English speaking
- Patient is unable to provide consent
- Patient is currently incarcerated
Trial locations and contacts
1 site in 1 country.
About this study
Background: Cesarean delivery is one of the most common obstetric procedures experienced among women who are pregnant.1 Women with Cesarean deliveries have a higher rate of peripartum opioid prescriptions and persistent opioid use compared to those with vaginal deliveries.2 Since 2002, prescription opioid use and misuse has significantly increased among women, including those who are pregnant, showing over 31% increase in past-month heroin use among women of childbearing age.3 This indicates the importance of focusing on maternal population for prescribed opioid medication management during the immediate postpartum period to prevent long-term persistent opioid misuse. Few evidence-based approaches are available to remotely manage prescription opioid use post-discharge.4 Recent advances in mobile technology have made it possible to monitor behavior and maintain communication in near real-time, long after patients are discharged from their surgical procedures.5-7 Using a virtual platform via use of mobile technology offers potential for sustainable implementation of a behavioral intervention and patient-provider communication even during the COVID-19 pandemic.8 Continuous Precision Medicine (CPM™; Research Triangle Park, NC) has developed a mobile app to overcome these barriers for tracking pain and pain medication use among post-surgery patients and tested the logistical and technological feasibility in postpartum patients at Temple OB/GYN. Collectively, our team brings expertise and collaborations between Temple University Hospital, RTI International, and CPM for the following Specific Aims:
Aim 1: To examine the preliminary impact of the CPM mobile app to reduce the use of opioids among women post-Cesarean surgery Hypothesis 1: Patients using the CPM application will use fewer Morphine Milligram Equivalents (MME) compared to the blister package group.
Aim 2: To establish correlates of pain medication use among women post-Cesarean surgery to estimate the appropriate recommendable dosages per model. Hypothesis 2: Structural and intermediary social determinants such as younger age, lower socioeconomic status, violence and trauma exposure, substance use disorder, and mental and physical health issues will be associated with more opioid medication use.
Read the detailed description
Experimental Design: A randomized pilot trial will be conducted with 100 females at Temple University Hospital immediately post-Cesarean delivery. The women will be randomized (1:1) to either: using the CPM mobile app and electronic monitoring blister packs (experimental group) or to blister packs only (control group). The primary outcome is Morphine Milligram Equivalents (MME). Secondary outcomes will be delay to dosages and pain scores. We will examine whether a mobile application found feasible by post-surgery patients and healthcare professionals has a preliminary impact on opioid medication use among women who are immediately postpartum and had Cesarean surgery. The CPM application provides patients with a detailed prescription regimen, allows a patient to report dose-by-dose pain scores, and helps the patient consider whether a dose is needed via gamification, and creates usage traceability for clinicians to reduce over-prescription. Linear regression, including ANOVA and repeated mixed models will be used to compare groups on the primary continuous outcomes of daily MME during the 10-day period. The initial models will only include a term for study group. Variables that are statistically significant (<0.05) by univariate analyses, as well as theoretically important covariates will be considered for inclusion in adjusted analyses to improve their precision. Pain scores as a secondary continuous outcome will be evaluated using regression models for linear and non-linear mixed effect models. If no significant differences in these outcomes were detected, resampling Bootstrap method will be used to estimate effect sizes (i.e., Cohen's d) and its 95% confidence intervals, considering potential non-normal distribution of data. Further, we will utilize structural equation modeling (SEM) for its greater flexibility and capacity of handling the structural relationship between measured variables and latent constructs.
- Conditions
- Opioid Misuse
- Being tested
- CPMRx
- Keywords
- opioid misuse, mobile application, cesarean section
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPMRxBehavioural
Patients use a mobile application to track pain medication usage and pain scores.
| Study group | Role | What they receive |
|---|---|---|
| Mobile App + BP | Experimental | Patients use a mobile application in addition to electronic monitoring blister packs for pain medications. Receives: Behavioral: CPMRx |
| BP | No intervention | Patients' pain medication is in electronic monitoring blister packs. |
| Mobile App Only | Experimental | Patients use a mobile application. Receives: Behavioral: CPMRx |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine Milligram Equivalents (MME) Used
Total number of Morphine Milligram Equivalents (MME) used during the postoperative period.
Measured: First 7 days following discharge
Secondary outcomes (1)
Pain Scores
Average pain scores by day, measured on a sliding scale from 0 (none) to 10 (worst pain)
Measured: Daily for 7 days following discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start12 May 2021
- Primary completion1 Aug 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opioid MisuseStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jessica Morgan
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Temple University
- Responsible party
- Sponsor-investigator, Jessica Morgan, Continuous Precision Medicine
- Investigators
- Gail Herrine, MD, Principal investigator, Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05461196
- Sponsor's protocol ID
- 28226
- Status last verified
- Aug 2023
- First submitted
- 13 Jul 2022
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abdo A, O'Connor M, Morgan JK, Hart L, Leib A, Walther SK, Tang A, Herrine G. Evaluation of a mobile application to decrease opioid misuse in patients undergoing cesarean section: a randomized controlled trial. BMC Pregnancy Childbirth. 2024 Dec 5;24(1):812. doi: 10.1186/s12884-024-06953-7.
PubMed 39639184
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decreasing Opioid Misuse and Habit-forming Behaviors Following Prescription in Patients Undergoing Cesarean Section
- ClinicalTrials.gov ID
- NCT05461196
- Acronym / sponsor ID
- 28226
- Conditions
- Opioid Misuse
- Keywords
- opioid misuse, mobile application, cesarean section
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Jessica MorganIndustry (pharma, biotech, devices)
- Collaborators
- Temple University
- Study start
- 12 May 2021 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 18 Jul 2022 (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.
Background: Cesarean delivery is one of the most common obstetric procedures experienced among women who are pregnant.1 Women with Cesarean deliveries have a higher rate of peripartum opioid prescriptions and persistent opioid use compared to those with vaginal deliveries.2 Since 2002, prescription opioid use and misuse has significantly increased among women, including those who are pregnant, showing over 31% increase in past-month heroin use among women of childbearing age.3 This indicates the importance of focusing on maternal population for prescribed opioid medication management during the immediate postpartum period to prevent long-term persistent opioid misuse. Few evidence-based approaches are available to remotely manage prescription opioid use post-discharge.4 Recent advances in mobile technology have made it possible to monitor behavior and maintain communication in near real-time, long after patients are discharged from their surgical procedures.5-7 Using a virtual platform via use of mobile technology offers potential for sustainable implementation of a behavioral intervention and patient-provider communication even during the COVID-19 pandemic.8 Continuous Precision Medicine (CPM™; Research Triangle Park, NC) has developed a mobile app to overcome these barriers for tracking pain and pain medication use among post-surgery patients and tested the logistical and technological feasibility in postpartum patients at Temple OB/GYN. Collectively, our team brings expertise and collaborations between Temple University Hospital, RTI International, and CPM for the following Specific Aims:
Aim 1: To examine the preliminary impact of the CPM mobile app to reduce the use of opioids among women post-Cesarean surgery Hypothesis 1: Patients using the CPM application will use fewer Morphine Milligram Equivalents (MME) compared to the blister package group.
Aim 2: To establish correlates of pain medication use among women post-Cesarean surgery to estimate the appropriate recommendable dosages per model. Hypothesis 2: Structural and intermediary social determinants such as younger age, lower socioeconomic status, violence and trauma exposure, substance use disorder, and mental and physical health issues will be associated with more opioid medication use.
Detailed description
Experimental Design: A randomized pilot trial will be conducted with 100 females at Temple University Hospital immediately post-Cesarean delivery. The women will be randomized (1:1) to either: using the CPM mobile app and electronic monitoring blister packs (experimental group) or to blister packs only (control group). The primary outcome is Morphine Milligram Equivalents (MME). Secondary outcomes will be delay to dosages and pain scores. We will examine whether a mobile application found feasible by post-surgery patients and healthcare professionals has a preliminary impact on opioid medication use among women who are immediately postpartum and had Cesarean surgery. The CPM application provides patients with a detailed prescription regimen, allows a patient to report dose-by-dose pain scores, and helps the patient consider whether a dose is needed via gamification, and creates usage traceability for clinicians to reduce over-prescription. Linear regression, including ANOVA and repeated mixed models will be used to compare groups on the primary continuous outcomes of daily MME during the 10-day period. The initial models will only include a term for study group. Variables that are statistically significant (<0.05) by univariate analyses, as well as theoretically important covariates will be considered for inclusion in adjusted analyses to improve their precision. Pain scores as a secondary continuous outcome will be evaluated using regression models for linear and non-linear mixed effect models. If no significant differences in these outcomes were detected, resampling Bootstrap method will be used to estimate effect sizes (i.e., Cohen's d) and its 95% confidence intervals, considering potential non-normal distribution of data. Further, we will utilize structural equation modeling (SEM) for its greater flexibility and capacity of handling the structural relationship between measured variables and latent constructs.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Mobile App + BP | Experimental | Behavioral: CPMRxPatients use a mobile application in addition to electronic monitoring blister packs for pain medications. |
| BP | No intervention | –Patients' pain medication is in electronic monitoring blister packs. |
| Mobile App Only | Experimental | Behavioral: CPMRxPatients use a mobile application. |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patient is a female adult between the ages of 18-50 years
- Patient is undergoing cesarean section procedure at Temple University Hospital
- Patient is able and willing to provide informed consent
- Patient has insurance that will cover cost of prescription drugs or is able to pay out-of-pocket
- Patient has their own smart mobile phone (>80% of the target population owns a mobile phone)
Key exclusion criteria (7 listed)
- Patient with contraindications to opioid medications, NSAIDs, or acetaminophen (including but not limited to allergy, intolerance, inability to swallow pills, etc.)
- Patient is unable to take tablets or tolerate oral intake
- Patient has a diagnosis of acute or chronic pain disorder
- Patient has used an opioid within the past 12 months
- Patient is non-English speaking
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 |
|---|---|---|
| CPMRxPatients use a mobile application to track pain medication usage and pain scores. | Behavioural | Mobile App + BP, Mobile App Only |
Primary outcome
Morphine Milligram Equivalents (MME) Used
Time frame: First 7 days following discharge
Total number of Morphine Milligram Equivalents (MME) used during the postoperative period.
1 secondary outcome
Pain Scores
Time frame: Daily for 7 days following discharge
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 21 Aug 2023.
- Derived from this study: PubMed 39639184Abdo A, O'Connor M, Morgan JK, Hart L, Leib A, Walther SK, Tang A, Herrine G. Evaluation of a mobile application to decrease opioid misuse in patients undergoing cesarean section: a randomized controlled trial. BMC Pregnancy Childbirth. 2024 Dec 5;24(1):812. doi: 10.1186/s12884-024-06953-7.
- Individual participant dataSharing planned: No
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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.
Gail Herrine, MD principal investigator
Temple University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPMRx in people with Opioid Misuse, run by Jessica Morgan 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 7 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 21 Aug 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. 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?
Morphine Milligram Equivalents (MME) Used (time frame: First 7 days following discharge). 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 NCT05461196, which also lists 1 linked publication.
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 21 Aug 2023.