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Technology-Enhanced Therapy for Buprenorphine Retention in Pregnant People

This study is looking at a new technology-enhanced therapy called EMPWR for pregnant people who are taking buprenorphine (like Suboxone, Subutex, or Zubsolv) to treat opioid use disorder. It compares EMPWR to standard medication monitoring. The EMPWR therapy includes four 60-minute sessions during pregnancy, a 30-minute session near the end of pregnancy, and six monthly sessions after childbirth, plus a mobile app. The study wants to see if this therapy helps people stay on their buprenorphine treatment. You might be able to join if you are pregnant (13 to 32 weeks), 18-45 years old, have opioid use disorder, and are prescribed buprenorphine. The study is currently unclear on its recruitment status.

Study design
This is an interventional study with 37 planned participants. You would be randomly assigned to either receive the EMPWR therapy or medication monitoring.
What's involved
If you receive the therapy, you would attend four 60-minute therapy appointments during pregnancy, one 30-minute session towards the end of pregnancy, and six monthly sessions after childbirth. You would also use a mobile application.
Compensation
Not stated in the trial record.
Follow-up
The study measures outcomes like recruitment feasibility, retention in treatment, and engagement in the intervention at Years 3-4.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06999811

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

Recruiting
NAAges 18–45Interventional
Medical University of South Carolina
~37 participants
Updated 2026-04-08 on ClinicalTrials.gov
What's tested:Empowering Pregnant Women and People Receiving medications for opioid use disorder (EMPWR)Medication monitoring (control)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Feasibility of Recruitment
Measured over Years 3-4
+2 more outcomes measured

Conditions

Opioid Use Disorder
Pregnancy

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AnxietyOpioid Use DisorderPregnancySleep Disorder

Where it's being run

1 sites across 1 states
South Carolina1

Study leadership

  • Sara Witcraft · PRINCIPAL_INVESTIGATOR · Medical University of South Carolina

Who to contact

Morgan Thomas
[email protected]
843-998-4211
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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Feasibility of RecruitmentYears 3-4

    Recruitment will be assessed by the proportion of participants who agree to participate in the trial vs. total approached; success is if ≥70% of approached PPP enroll.

  • Retention in Active Treatment (EMPWR)Years 3-4

    Retention will be assessed by the proportion of participants who complete 3- and 6-month postpartum follow-up assessments vs. those who prematurely terminate; success is if 70% of participants are retained for follow-up assessments.

  • Engagement in interventionYears 3-4

    Overall engagement will be measured separately for the EMPWR behavioral intervention and mobile application (EMPWR condition) and daily diary completion (MM condition). To measure engagement in the EMPWR condition, we will consider it successful if 70% of participants attend all EMPWR behavioral intervention sessions, and separately, actively engage with the active components of the mobile application (i.e., 50% days logged buprenorphine, 50% assigned at-home "Practice" exercises completed). In the MM condition, we will consider completing 70% of daily diaries as successful engagement.