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| ID | Type | Description | Link |
|---|---|---|---|
| 5R34DA050453 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| uMAT-R mobile app with coaching component | Device | uMAT-R recovery mobile app with coaching component |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Baseline, 1 month |
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Pregnant and Postpartum Participants:
Inclusion Criteria:
Exclusion Criteria:
1) Currently incarcerated
Providers Inclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
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Please note that outcome results are only included for pregnant and postpartum participants.
Due to challenges recruiting pregnant and postpartum individuals, all pregnant and post-partum participants recruited were enrolled in the Aim 3 RCT and that sample is reported here.
Pregnant and postpartum individuals who met eligibility criteria were shown the informed consent form. Those who consented to participate and completed their baseline survey were provided access to the intervention (N= 109).
Providers from regional treatment facilities in both Missouri and neighboring Illinois were recruited via email or telephone for enrollment (n=16).
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Group- No Engagement With Intervention | Participants who did not engage with the mobile app intervention |
| FG001 | Experimental Group- Mobile App Intervention With Coach | Participants who engaged with the mobile app intervention |
| FG002 | Providers | Providers who support individuals in recovery from SUD, including during pregnancy and/or the postpartum period |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Group- No Engagement With Intervention | Participants who did not engage with the mobile app intervention |
| BG001 | Experimental Group- Mobile App Intervention With Coach |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale (total score, 0 to 30) | Baseline, 1 month |
|
Adverse event data were collected for up to 1 month following baseline assessment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Group- No Engagement With Intervention | Participants who did not engage with the mobile app intervention |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Patricia Cavazos-Rehg | Washington University School of Medicine | 314-362-2152 | pcavazos@wustl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 27, 2023 | Dec 12, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 25, 2025 | Mar 16, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D016739 | Behavior, Addictive |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D003192 | Compulsive Behavior |
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Participants who engaged with the mobile app intervention
| BG002 | Providers | Providers who support individuals in recovery from SUD, including during pregnancy and/or the postpartum period |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Control Group- No Engagement With Intervention |
Participants who did not engage with the mobile app intervention |
| OG001 | Experimental Group- Mobile App Intervention With Coach | Participants who engaged with the mobile app intervention |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale ranges from 0 to 5 | Baseline, 1 month |
|
|
|
|
| 0 |
| 52 |
| 0 |
| 52 |
| 0 |
| 52 |
| EG001 | Experimental Group- Mobile App Intervention With Coach | Participants who engaged with the mobile app intervention | 0 | 57 | 0 | 57 | 0 | 57 |
| EG002 | Providers | Providers who support individuals in recovery from SUD, including during pregnancy and/or the postpartum period | 0 | 13 | 0 | 13 | 0 | 13 |
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| D007175 | Impulsive Behavior |
| D001519 | Behavior |
| Other |
Bivariate analyses were conducted to compare the distribution of pre-to-post change scores (post - pre) between the groups. |