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RECRUITING
NCT06999811
NA

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

Sponsor: Medical University of South Carolina

View on ClinicalTrials.gov

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. 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 Details

Gender

FEMALE

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

37

Start Date

2025-11-05

Completion Date

2028-10-15

Last Updated

2026-04-08

Healthy Volunteers

No

Interventions

BEHAVIORAL

Empowering Pregnant Women and People Receiving medications for opioid use disorder (EMPWR)

EMPWR is evidence-informed, behavioral intervention to address risk factors for fear of opioid withdrawal, craving, and stress, with an adjective mobile application among pregnant women receiving opioid agonist therapies. The goal of EMPWR is to promote medication retention and adherence.

OTHER

Medication monitoring (control)

Participants will record the dose and time buprenorphine was taken for two months via REDCap daily diaries, which will be delivered via text.

Locations (1)

Medical University of South Carolina

Charleston, South Carolina, United States