Technology-Enhanced Therapy vs. Medication Monitoring for Buprenorphine Retention in Pregnant Persons
Medical University of South Carolina
37 participants
Nov 5, 2025
INTERVENTIONAL
Conditions
Summary
This study involves testing how useful a technology-enhanced therapy is for pregnant people prescribed buprenorphine for the treatment of opioid use disorder, compared to medication monitoring. Participants are randomized to one of the conditions. If participants are randomized to receive the therapy, participants will attend four 60-minute therapy appointments during pregnancy with an additional 30-minute therapy session towards the end of pregnancy, and 6 additional monthly postpartum (after childbirth) sessions (0-6 months postpartum). As part of the therapy program, participants will receive access to a mobile application, which will be accessible for the duration of the study. If participants are randomized to medication monitoring, participants will be asked to log each time participants take their medication for two months. All participants will also be asked to complete questionnaires at enrollment and again at 3-month postpartum and 6-months postpartum, and will be contacted randomly throughout the study to perform a medication count. The total duration of the study is between 8-12 months depending on when participants enroll (early second trimester-mid third trimester).
Eligibility
Inclusion Criteria5
- currently pregnant and between 13 weeks and 0 days to 32 weeks and 6 days gestational age
- current OUD or history of OUD within past 3 years
- confirmed prescription for sublingual buprenorphine products (i.e., Suboxone, Subutex, Zubsolv) for the purpose of treating OUD
- living in the United States
- between 18-45 years of age
Exclusion Criteria6
- carrying multiples
- high-risk pregnancies including the following conditions: active hyperemesis at the time of consent or hospitalization for intractable nausea and vomiting in the current pregnancy, hypertensive disorders of pregnancy (e.g., gestational hypertension, preeclampsia), placenta previa, or vaginal bleeding in current pregnancy after the first trimester
- current psychotic symptoms and/or active suicidal intent
- experiencing cognitive or emotional impairment that precludes providing informed consent
- incarcerated/pending incarceration or institutionalized during the study period
- non-English speaking.
Interventions
EMPWR is evidence-informed, behavioral intervention to address risk factors for fear of opioid withdrawal, craving, and stress, with an adjective mobile application among pregnant women receiving opioid agonist therapies. The goal of EMPWR is to promote medication retention and adherence.
Participants will record the dose and time buprenorphine was taken for two months via REDCap daily diaries, which will be delivered via text.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06999811