N/A
N=228
Treatment of Pregnant Women With OUD
Opioid-use Disorder
Bottom Line
View on ClinicalTrials.gov: NCT04240392 ↗Enrolled (actual)
228
Serious AEs
17.5%
Results posted
May 2025
Primary outcome: Primary: Treatment Engagement — 78; 64; 109; 92 Participants — p=0.5340
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Collaborative Care (CC) (Behavioral); Extension for Community Healthcare Outcomes (ECHO) (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Yale University
- Primary completion
- Oct 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Treatment Engagement |
78; 64; 109; 92 | 0.5340 |
| PRIMARY Treatment Retention |
17; 12; 99; 87; 18; 11 | 0.600 |
| PRIMARY Patient Activation Measure (PAM) |
74.77; 76.6; 78.32; 78.14; 77.37; 78.55 | 0.518 |
Summary
The investigators are testing two models of support for pregnant women with an opioid use disorder (OUD)
Eligibility Criteria
Inclusion Criteria
- Provision of signed and dated informed consent form
- Females age 18 or older
- Documented pregnancy in the medical record at less than 34 weeks gestation
- Delivery date no later than July 1, 2024
- Willingness to adhere to the study schedule
- Confirmed opioid use disorder by the DSM-5 Opioid Use Disorder questionnaire
- Ability to communicate in English
- No current plan to move out of the obstetrical provider treatment area within the study timeframe of approximately 44 weeks
Exclusion Criteria
- Experiencing cognitive or emotional impairment that precludes the participant from providing informed consent
- Current hospitalization, incarceration, or institutionalization (if women present for care after institutionalization, participation is possible
- Current court case pending that would make incarceration likely during the study treatment period (approximately 44 weeks)
Data sourced from ClinicalTrials.gov (NCT04240392). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.