Technology-enhanced therapy compared with medication monitoring to help pregnant people stay on buprenorphine
Official title: Technology-Enhanced Therapy vs. Medication Monitoring for Buprenorphine Retention in Pregnant Persons
Run by Medical University of South Carolina · NCT06999811 · Data updated 2026-11-12
This project will see if a short therapy program plus a mobile app helps pregnant people on buprenorphine stay on their medication better than medication monitoring.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 45 Years |
| Sex | Women only |
| Enrollment | 37 (estimated) |
| Sponsor | Medical University of South Carolina Academic / other |
| Locations | 1 site (Charleston, South Carolina) |
| Status | Recruiting |
| Started | November 5, 2025 |
| Main results expected | October 15, 2028 |
| Study ends | October 15, 2028 |
| Registry record updated | April 8, 2026 |
| Trial ID | NCT06999811 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are people aged 18–45 in the United States who are 13 0/7 to 32 6/7 weeks pregnant, have current or recent (within 3 years) opioid use disorder, and have a confirmed prescription for sublingual buprenorphine.
✕Probably not a fit
Patients who are carrying multiples, have high-risk pregnancy complications, current psychosis or active suicidal intent, cognitive impairment precluding consent, are incarcerated, or are non-English-speaking may not benefit or be eligible for this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Pregnant people prescribed sublingual buprenorphine are randomized to either a technology-enhanced behavioral intervention plus access to a mobile app or to a medication-monitoring control. The intervention includes four 60-minute therapy sessions during pregnancy, a 30-minute late-pregnancy session, and six monthly postpartum sessions, with an app that provides medication reminders and adherence support. The control arm asks participants to log each medication dose for two months. All participants complete questionnaires at enrollment, 3 months postpartum, and 6 months postpartum to measure retention and adherence outcomes.
Why it matters
Potential benefit: If successful, the approach could improve continuation of buprenorphine through the postpartum period and lower postpartum overdose risk.
How similar studies have gone: Behavioral programs and mobile apps have shown promise for medication adherence in other populations, but randomized evidence specifically for pregnant people on buprenorphine is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Medical University of South Carolina
Charleston, South Carolina, United States Recruiting
Study contacts
- Principal investigator: Sara Witcraft — Medical University of South Carolina
- Study coordinator: Morgan Thomas
- Email: thomamor@musc.edu
- Phone: 843-998-4211
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.