Trial Outcomes & Findings for mHealth to Help Pregnant and Postpartum Women in Recovery for Opioid Use Disorder (NCT NCT06701123)
NCT ID: NCT06701123
Last Updated: 2026-04-03
Results Overview
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.
COMPLETED
EARLY_PHASE1
125 participants
Baseline, 1 month
2026-04-03
Participant Flow
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).
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.
Participant milestones
| Measure |
Control Group- No Engagement With Intervention
Participants who did not engage with the mobile app intervention
|
Experimental Group- Mobile App Intervention With Coach
Participants who engaged with the mobile app intervention
|
Providers
Providers who support individuals in recovery from SUD, including during pregnancy and/or the postpartum period
|
|---|---|---|---|
|
Overall Study
STARTED
|
52
|
57
|
16
|
|
Overall Study
Completed Baseline Assessment
|
27
|
44
|
16
|
|
Overall Study
Completed 1 Month Assessment
|
11
|
29
|
13
|
|
Overall Study
COMPLETED
|
52
|
57
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
mHealth to Help Pregnant and Postpartum Women in Recovery for Opioid Use Disorder
Baseline characteristics by cohort
| Measure |
Control Group- No Engagement With Intervention
n=52 Participants
Participants who did not engage with the mobile app intervention
|
Experimental Group- Mobile App Intervention With Coach
n=57 Participants
Participants who engaged with the mobile app intervention
|
Providers
n=13 Participants
Providers who support individuals in recovery from SUD, including during pregnancy and/or the postpartum period
|
Total
n=122 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
Age of Participants · 18-30 years old
|
31 Participants
n=5 Participants
|
37 Participants
n=5 Participants
|
2 Participants
n=10 Participants
|
70 Participants
n=5 Participants
|
|
Age, Customized
Age of Participants · 31-50 years old
|
16 Participants
n=5 Participants
|
18 Participants
n=5 Participants
|
9 Participants
n=10 Participants
|
43 Participants
n=5 Participants
|
|
Age, Customized
Age of Participants · 51+
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=10 Participants
|
2 Participants
n=5 Participants
|
|
Age, Customized
Age of Participants · Missing
|
5 Participants
n=5 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=5 Participants
|
57 Participants
n=5 Participants
|
9 Participants
n=10 Participants
|
118 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=10 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
18 Participants
n=5 Participants
|
18 Participants
n=5 Participants
|
2 Participants
n=10 Participants
|
38 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=5 Participants
|
35 Participants
n=5 Participants
|
9 Participants
n=10 Participants
|
70 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=10 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=10 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=5 Participants
|
37 Participants
n=5 Participants
|
12 Participants
n=10 Participants
|
77 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
23 Participants
n=5 Participants
|
18 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
41 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 1 monthCraving 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.
Outcome measures
| Measure |
Control Group- No Engagement With Intervention
n=52 Participants
Participants who did not engage with the mobile app intervention
|
Experimental Group- Mobile App Intervention With Coach
n=57 Participants
Participants who engaged with the mobile app intervention
|
|---|---|---|
|
Cravings
Baseline
|
11.90 score on a scale (total score, 0 to 30)
Standard Deviation 8.01
|
8.94 score on a scale (total score, 0 to 30)
Standard Deviation 8.59
|
|
Cravings
1-month follow up
|
11.10 score on a scale (total score, 0 to 30)
Standard Deviation 10.18
|
8.21 score on a scale (total score, 0 to 30)
Standard Deviation 9.19
|
PRIMARY outcome
Timeframe: Baseline, 1 monthMOUD 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.
Outcome measures
| Measure |
Control Group- No Engagement With Intervention
n=52 Participants
Participants who did not engage with the mobile app intervention
|
Experimental Group- Mobile App Intervention With Coach
n=57 Participants
Participants who engaged with the mobile app intervention
|
|---|---|---|
|
MOUD Attitudes
Baseline
|
3.52 score on a scale ranges from 0 to 5
Standard Deviation 1.20
|
3.35 score on a scale ranges from 0 to 5
Standard Deviation 1.41
|
|
MOUD Attitudes
1-month follow-up
|
3.11 score on a scale ranges from 0 to 5
Standard Deviation 1.19
|
2.92 score on a scale ranges from 0 to 5
Standard Deviation 1.81
|
Adverse Events
Control Group- No Engagement With Intervention
Experimental Group- Mobile App Intervention With Coach
Providers
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Patricia Cavazos-Rehg
Washington University School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place