Status:
RECRUITING
Technology-Enhanced Therapy vs. Medication Monitoring for Buprenorphine Retention in Pregnant Persons
Lead Sponsor:
Medical University of South Carolina
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Opioid Use Disorder
Pregnancy
Eligibility:
FEMALE
18-45 years
Phase:
NA
Brief 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. Partic...
Detailed Description
Medication for opioid use disorder (MOUD) can effectively prevent overdose and death for pregnant and postpartum people with opioid use disorder (OUD). Yet, only half of birthing people continue to us...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 5 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 15 2028
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT06999811
Start Date
November 5 2025
End Date
October 15 2028
Last Update
November 21 2025
Active Locations (1)
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1
Medical University of South Carolina
Charleston, South Carolina, United States, 29403