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.

Recruitment status

COMPLETED

Study phase

EARLY_PHASE1

Target enrollment

125 participants

Primary outcome timeframe

Baseline, 1 month

Results posted on

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

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

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 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.

Outcome measures

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 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.

Outcome measures

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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Experimental Group- Mobile App Intervention With Coach

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Providers

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

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

Phone: 314-362-2152

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place