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

Recruiting now · Not applicable

Conditions studied: Opioid Use Disorder, Pregnancy

In brief

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).

Key facts

Study ID

NCT06999811

Run by

Medical University of South Carolina

People needed

37

Starts

2025-11-05

Expected to finish

2028-10-15

Last updated by the study team

2026-04-08

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Medical University of South Carolina — Charleston, South Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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