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

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).

NCT Number	NCT06999811
Lead Sponsor	Medical University of South Carolina Collaborators: National Institute on Drug Abuse (NIDA)
Conditions	Opioid Use Disorder, Pregnancy
Enrollment	37 participants
Start Date	2025-11-05
Primary Completion	2028-10-15 (estimated)
Study Completion	2028-10-15 (estimated)
Updated on ClinicalTrials.gov	2026-04-08