NCT06999811

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 37 (estimated)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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).

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 use MOUD postpartum, increasing risk for overdose two-fold. This study will evaluate feasibility of RCT methodology for a technology-enhanced behavioral intervention that aims to improve retention in and adherence to MOUD during the peripartum period compared to control (medication monitoring). The intervention contains a brief behavioral intervention targeting malleable risk factors for treatment dropout, opioid cravings, and return to illicit opioid use: anxiety sensitivity and sleep deficiency. An adjunctive mobile application will supplement therapy sessions and contains a medication adherence feature involving daily (or multiple/day) notification reminder to take medication at a scheduled time and dose consistent with the participant's prescription. This study is supported by funding from the NIH HEAL Initiative (https://heal.nih.gov/).

Conditions

• Opioid Use Disorder
• Pregnancy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-11-05
• Primary completion: 2028-10-15
• Completion: 2028-10-15
• First posted: 2025-05-31
• Last updated: 2026-04-08

Locations

1 site across 1 country: United States