Open Trial of Technology-Enhanced Behavioral Intervention for Buprenorphine Retention in Pregnant and Postpartum People

March 23, 2026 updated by: Sara Witcraft, Medical University of South Carolina

EMPWR Pilot Trial: Treatment Retention in Medication for Opioid Use Disorder Among Pregnant and Postpartum Women

This study involves testing how useful a technology-enhanced intervention is for pregnant people prescribed buprenorphine for the management of opioid use disorder. The intervention being studied is a brief therapy protocol and a mobile application. Participation involves four 60-minute therapy appointments during pregnancy, and four 30-minute therapy appointments at the end of pregnancy through 3 months postpartum. The mobile application will be accessible for at least the duration of the study. Participants will also be asked to complete questionnaires at enrollment and again at 1-month postpartum and 3-months postpartum, will send monthly photos of their prescription bottle/box, and will be contacted randomly throughout the study to perform a medication count. The total duration of the study is between 5-9 months depending on when you enroll (early second trimester-mid third trimester). Compensation is provided.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Medication for opioid use disorder (MOUD) can effectively prevent overdose and death for pregnant and postpartum people with opioid use disorder (OUD). Yet, only half of birthing people continue to use MOUD postpartum, increasing risk for overdose two-fold. This study will evaluate acceptability of a technology-enhanced behavioral intervention that aims to improve retention in and adherence to MOUD during the peripartum period. The intervention contains a brief behavioral intervention targeting malleable risk factors for treatment dropout, opioid cravings, and return to illicit opioid use: anxiety sensitivity and sleep deficiency. An adjunctive mobile application will supplement therapy sessions and contains a medication adherence feature involving daily (or multiple/day) notification reminder to take medication at a scheduled time and dose consistent with the participant's prescription.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29403
        • Medical University of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Currently pregnant and less than 33 weeks gestational age,
  • 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 (i.e., twins, triplets, etc.);
  • High-risk pregnancies including the following conditions: hyperemesis defined as hospitalization for intractable nausea and vomiting, 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Empowering Pregnant Women and People Receiving Medications for Opioid Use Disorder
EMPWR is a two-pronged intervention model comprised of 1) a provider-driven, telemedicine-based behavioral intervention to mitigate anxiety sensitivity and sleep deficiency and enhance peripartum buprenorphine retention, and 2) an adjunctive mobile application to promote patients' buprenorphine adherence and use of therapy skills learned through the behavioral intervention. The EMPWR therapy protocol is comprised of five 30-60-minute sessions delivered weekly or biweekly by a therapist during the second and/or third trimester of pregnancy, and three 30-minute booster sessions delivered months 1-3 postpartum.
Behavioral: Empowering Pregnant Women and People Receiving Medications for Opioid Use Disorder
Two-pronged intervention model: 1) behavioral intervention utilizing interoceptive exposures and cognitive behavioral therapy for insomnia and, 2) mobile application that facilitates medication adherence.
Other Names:
  • EMPWR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intervention Feasibility
Time Frame: 1 year
Feasibility of the intervention (e.g., Recruitment: 20 pregnant women with OUD prescribed buprenorphine; Study retention: ≥50% participants retained through 3-month postpartum assessment; Protocol adherence: ≥50% attend all EMPWR therapy sessions;145 Satisfaction: qualitative feedback to assess what participants liked/did not like about the intervention)
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Buprenorphine retention
Time Frame: 6 months
Prescription drug monitoring program (y/n)
6 months
Buprenorphine adherence
Time Frame: 6 months
Mobile application data, medication possession ratios (%)
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of South Carolina

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Sara Witcraft, Medical University of South Carolina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 6, 2024

Primary Completion (Actual)

January 13, 2026

Study Completion (Actual)

January 13, 2026

Study Registration Dates

First Submitted

July 3, 2024

First Submitted That Met QC Criteria

July 3, 2024

First Posted (Actual)

July 11, 2024

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 23, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00137982
  • K12DA031794 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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