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

Part of paid clinical trials in Charleston, South Carolina.

Sponsor
Medical University of South Carolina
Study ID
NCT06999811
Status
Recruiting
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Conditions

  • Opioid Use Disorder
  • Pregnancy

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • Empowering Pregnant Women and People Receiving medications for opioid use disorder (EMPWR) — BEHAVIORAL
    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.
  • Medication monitoring (control) — OTHER
    Participants will record the dose and time buprenorphine was taken for two months via REDCap daily diaries, which will be delivered via text.

Study Details

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 Dates

Start date
Nov 5, 2025
Status verified
Nov 2025
Primary completion
Oct 15, 2028
Completion
Oct 15, 2028

Study Design

Enrollment
37 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: EMPWR
    Brief cognitive-behavioral intervention and mobile application
  • Active Comparator: Control
    medication monitoring

Primary Outcome Measure

Feasibility of Recruitment [ Time Frame: Years 3-4 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Medical University of South CarolinaCharlestonSouth Carolina29403
Morgan Thomas
[email protected]
843-998-4211
Sara M Witcraft, PhD (PRINCIPAL_INVESTIGATOR)

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Medical University of South Carolina· Charleston, SC

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