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Technology-Enhanced Therapy vs. Medication Monitoring for Buprenorphine Retention in Pregnant Persons

RecruitingNAAges 18 Years - 45 YearsFemaleMedical University of South Carolina
NCT06999811 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 questionn

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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.
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What it tests

  • Empowering Pregnant Women and People Receiving medications for opioid use disorder (EMPWR)
  • Medication monitoring (control)
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Where

1 site
Medical University of South Carolina
Charleston, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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