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

NCT06999811 | Recruiting

• 2 other identifiers: Pro001410601K23DA062794-01
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Feasibility of Recruitment

  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.

  Years 3-4

• Retention in Active Treatment (EMPWR)

  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.

  Years 3-4

• Engagement in intervention

  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.

  Years 3-4

Study Arms (2)

EMPWR

EXPERIMENTAL

Brief cognitive-behavioral intervention and mobile application

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

Control

ACTIVE COMPARATOR

medication monitoring

Other: Medication monitoring (control)

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.

EMPWR

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.

Control

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Pregnant people with opioid use disorder (OUD) receiving buprenorphine formulations
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29403, United States

RECRUITING

MeSH Terms

Conditions

Opioid-Related Disorders; Anxiety Disorders; Psychological Well-Being; Sleep Wake Disorders; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Personal Satisfaction; Behavior; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sara Witcraft

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Morgan Thomas

CONTACT

843-998-4211; thomamor@musc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor-Faculty

Study Record Dates

• First Submitted: May 15, 2025
• First Posted: May 31, 2025
• Study Start: November 5, 2025
• Primary Completion (Estimated): October 15, 2028
• Study Completion (Estimated): October 15, 2028
• Last Updated: April 8, 2026

Record last verified: 2025-11

Locations

US (1)