Recruiting

Technology-Enhanced Therapy

Sponsor:

Medical University of South Carolina

Code:

NCT06999811

Conditions

Opioid Use Disorder

Pregnancy

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

Interventions

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

Medication monitoring (control)

Study Details

Brief 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).

Conditions

Opioid Use Disorder

Pregnancy

Study ID

NCT06999811

Start date

Nov 5, 2025

Status verified date

Nov, 2025

Completion date

Oct 15, 2028

Anticipated

Primary completion date

Oct 15, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Design

Enrollment

37 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: EMPWR

Brief cognitive-behavioral intervention and mobile application

active comparator: Control

medication monitoring

Interventions

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.

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.

Primary outcome measure

  • Feasibility of Recruitment [ Time Frame: Years 3-4 ]
  • Retention in Active Treatment (EMPWR) [ Time Frame: Years 3-4 ]
  • Engagement in intervention [ Time Frame: Years 3-4 ]

Central Contacts and Locations

Central contacts

Locations

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29403

Contacts

Principal Investigator:

Sara M Witcraft, PhD

More Information

Sponsor

Medical University of South Carolina

Last update posted

Apr 8, 2026

Last verified

Nov, 2025

Keywords

  • Anxiety
  • Mental Health
  • Pregnancy
  • Psychiatry
  • Sleep Disorders
  • Substance Use
  • Women's Health

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Medical University of South Carolina on 2026-04-08.