Opioid Use DisordersEarly Phase 1NCT06701123
mHealth to Help Pregnant and Postpartum Women in Recovery for Opioid Use Disorder
A Early Phase 1 study testing uMAT-R mobile app with coaching component in people with Opioid Use Disorders, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The opioid epidemic has resulted in widespread detrimental consequences among vulnerable populations in Missouri, especially among pregnant and postpartum women (PPW) with opioid use disorder (OUD). Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Opioid Use Disorders
- What is being tested?
- uMAT-R mobile app with coaching component
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2023to 1 Oct 2024
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pregnant or up to 3 years postpartum
- Receiving treatment consenting treatment facility and/or referred from other participants or community partners
- Adult (≥18 years of age)
- U.S. resident
- OUD or history of opioid misuse
- Fluent in English
- Own a smartphone with an iOS or Android operating system
Who cannot join
- 1) Currently incarcerated
- Providers Inclusion Criteria:
- Works with pregnant and postpartum people with opioid use disorder and/or at a recovery community center (e.g. a staff person, counselor, social worker, psychiatrist, nurse).
- Adult (≥18 years of age)
- Fluent in English
- Own a smartphone with an iOS or Android operating system
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
The opioid epidemic has resulted in widespread detrimental consequences among vulnerable populations in Missouri, especially among pregnant and postpartum women (PPW) with opioid use disorder (OUD). Perinatal use of medication-assisted treatment (MAT) within a comprehensive treatment plan is the current standard of care, however PPW struggling with OUD may underestimate or misjudge its benefits. At the same time, emerging findings signal that mobile health (mHealth) technologies have the potential to support healthier behaviors among individuals with OUD. In this project, we will test the utility of a theoretically-based digital therapeutics tool (uMAT-R) to encourage MAT adherence and treatment retention while considering the unique needs of PPW. We will conduct a pilot randomized controlled trial (RCT) among adult PPW with OUD. This RCT is designed to test the feasibility, acceptability, and preliminary efficacy of uMAT-R mobile app versus a control group (who receive treatment-as-usual) regarding participants' treatment adherence, sobriety, and improved MAT attitudes, norms, and perceived control. Recruitment for all Aims will occur at a clinic in St. Louis, Missouri that provides perinatal medication-assisted treatment (MAT) and high-risk maternity care to PPW struggling with OUD. Clinically meaningful effect size and attrition estimates will aid in the planning of a larger RCT in which we will test uMAT-R on a larger scale and expand our recruitment to other clinics across Missouri and other states. In addition, local providers who work with pregnant and postpartum people with substance use disorder and/or at a recovery community center will be recruited to provide their feedback. This novel technology could be an invaluable tool to assist physicians in the treatment of OUD among PPW.
- Conditions
- Opioid Use Disorders
- Being tested
- uMAT-R mobile app with coaching component
- Keywords
- Addiction, mhealth, Women, Substance use disorder, intervention
- Medical subject headings
- Opioid-Related Disorders, Behavior, Addictive, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
uMAT-R mobile app with coaching componentDevice
uMAT-R recovery mobile app with coaching component
| Study group | Role | What they receive |
|---|---|---|
| Control Group- Access to uMAT-R but did not engage | No intervention | Control Group Access to uMAT-R but did not engage |
| Experimental Group- Mobile App with Coaching Feature | Experimental | Access to a coached program on uMAT-R App Receives: Device: uMAT-R mobile app with coaching component |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cravings
Craving was assessed using the Penn Alcohol Craving Scale (PACS), adapted for opioid craving by replacing alcohol-specific wording with opioid-specific wording. The PACS is a 5-item self-report measure assessing craving over the past week. However, in the current version, we only included 3 items: "(1) How much do you currently crave illicit substances (i.e. opioids, meth, cocaine, MDMAs, etc.)", "(2) In the past week, please rate how strong your desire to use illicit substances has been when something in the environment has reminded you of the illicit substance(s)." and "(3) Please imagine yourself in the environment in which you previous used illicit substances. If you were in this environment today and if it were the time of day that you typically use, what is the likelihood that you would use illicit substances today?" Each item is scored 0 to 10 and summed to a total score ranging from 0 to 30, with higher scores indicating greater craving/worse outcome.
Measured: Baseline, 1 month
MOUD Attitudes
MOUD attitudes were assessed using an adapted 8-item scale originally developed to assess negative attitudes toward methadone (Schwartz et al., 2008) and modified to reference medications for opioid use disorder (e.g., buprenorphine, methadone, naltrexone). Each item was rated on a 5-point scale from 1 to 5. A total score was calculated as the mean of the 8 items, with possible values ranging from 1 to 5. Higher scores indicate more negative attitudes toward MOUD/worse outcome.
Measured: Baseline, 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2024
- Study start1 Jul 2023
- Primary completion1 Oct 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Opioid Use DisordersStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06701123
- Sponsor's protocol ID
- 202102207
- Other IDs
- 5R34DA050453
- Status last verified
- Mar 2026
- First submitted
- 20 Nov 2024
- Last updated
- 3 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- mHealth to Help Pregnant and Postpartum Women in Recovery for Opioid Use Disorder
- ClinicalTrials.gov ID
- NCT06701123
- Acronym / sponsor ID
- 202102207
- Conditions
- Opioid Use Disorders
- Keywords
- Addiction, mhealth, Women, Substance use disorder, intervention
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 22 Nov 2024 (actual)
- Results
- Posted 3 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The opioid epidemic has resulted in widespread detrimental consequences among vulnerable populations in Missouri, especially among pregnant and postpartum women (PPW) with opioid use disorder (OUD). Perinatal use of medication-assisted treatment (MAT) within a comprehensive treatment plan is the current standard of care, however PPW struggling with OUD may underestimate or misjudge its benefits. At the same time, emerging findings signal that mobile health (mHealth) technologies have the potential to support healthier behaviors among individuals with OUD. In this project, we will test the utility of a theoretically-based digital therapeutics tool (uMAT-R) to encourage MAT adherence and treatment retention while considering the unique needs of PPW. We will conduct a pilot randomized controlled trial (RCT) among adult PPW with OUD. This RCT is designed to test the feasibility, acceptability, and preliminary efficacy of uMAT-R mobile app versus a control group (who receive treatment-as-usual) regarding participants' treatment adherence, sobriety, and improved MAT attitudes, norms, and perceived control. Recruitment for all Aims will occur at a clinic in St. Louis, Missouri that provides perinatal medication-assisted treatment (MAT) and high-risk maternity care to PPW struggling with OUD. Clinically meaningful effect size and attrition estimates will aid in the planning of a larger RCT in which we will test uMAT-R on a larger scale and expand our recruitment to other clinics across Missouri and other states. In addition, local providers who work with pregnant and postpartum people with substance use disorder and/or at a recovery community center will be recruited to provide their feedback. This novel technology could be an invaluable tool to assist physicians in the treatment of OUD among PPW.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group- Access to uMAT-R but did not engage | No intervention | –Control Group Access to uMAT-R but did not engage |
| Experimental Group- Mobile App with Coaching Feature | Experimental | Device: uMAT-R mobile app with coaching componentAccess to a coached program on uMAT-R App |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Pregnant or up to 3 years postpartum
- Receiving treatment consenting treatment facility and/or referred from other participants or community partners
- Adult (≥18 years of age)
- U.S. resident
- OUD or history of opioid misuse
Key exclusion criteria (6 listed)
- 1) Currently incarcerated
- Works with pregnant and postpartum people with opioid use disorder and/or at a recovery community center (e.g. a staff person, counselor, social worker, psychiatrist, nurse).
- Adult (≥18 years of age)
- Fluent in English
- Own a smartphone with an iOS or Android operating system
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 |
|---|---|---|
| uMAT-R mobile app with coaching componentuMAT-R recovery mobile app with coaching component | Device | Experimental Group- Mobile App with Coaching Feature |
Primary outcome
Cravings
Time frame: Baseline, 1 month
Craving was assessed using the Penn Alcohol Craving Scale (PACS), adapted for opioid craving by replacing alcohol-specific wording with opioid-specific wording. The PACS is a 5-item self-report measure assessing craving over the past week. However, in the current version, we only included 3 items: "(1) How much do you currently crave illicit substances (i.e. opioids, meth, cocaine, MDMAs, etc.)", "(2) In the past week, please rate how strong your desire to use illicit substances has been when something in the environment has reminded you of the illicit substance(s)." and "(3) Please imagine yourself in the environment in which you previous used illicit substances. If you were in this environment today and if it were the time of day that you typically use, what is the likelihood that you would use illicit substances today?" Each item is scored 0 to 10 and summed to a total score ranging from 0 to 30, with higher scores indicating greater craving/worse outcome.
MOUD Attitudes
Time frame: Baseline, 1 month
MOUD attitudes were assessed using an adapted 8-item scale originally developed to assess negative attitudes toward methadone (Schwartz et al., 2008) and modified to reference medications for opioid use disorder (e.g., buprenorphine, methadone, naltrexone). Each item was rated on a 5-point scale from 1 to 5. A total score was calculated as the mean of the 8 items, with possible values ranging from 1 to 5. Higher scores indicate more negative attitudes toward MOUD/worse outcome.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing uMAT-R mobile app with coaching component in people with Opioid Use Disorders, run by Washington University School of Medicine 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 7 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 3 Apr 2026. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Cravings (time frame: Baseline, 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Apr 2026.