RecruitingNot ApplicableNCT06999811

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


Sponsor

Medical University of South Carolina

Enrollment

37 participants

Start Date

Nov 5, 2025

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two approaches to supporting pregnant people with opioid use disorder (OUD) who are taking buprenorphine (a medication to treat opioid addiction): a technology-based therapy app versus standard medication monitoring — to see which better helps them stay on their treatment. **You may be eligible if...** - You are between 13 and 32 weeks pregnant - You are 18–45 years old - You have a current or recent history of opioid use disorder - You have a prescription for sublingual buprenorphine (Suboxone, Subutex, or Zubsolv) for opioid use disorder - You live in the United States **You may NOT be eligible if...** - You are carrying twins or multiples - You have a high-risk pregnancy condition (severe nausea/vomiting requiring hospitalization, high blood pressure disorders, placenta previa, or abnormal bleeding after the first trimester) - You have active psychosis or active suicidal intent - You are incarcerated or expect to be during the study - You do not speak English Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BEHAVIORALEmpowering 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.

OTHERMedication 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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06999811


Related Trials