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

NCT06496230 | Completed Early Phase 1 DMC

• 2 other identifiers: Pro00137982K12DA031794
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Opioid Use Disorder; Pregnancy Related

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Intervention Feasibility

  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 Outcomes (2)

• Buprenorphine retention

  6 months

• Buprenorphine adherence

  6 months

Study Arms (1)

Empowering Pregnant Women and People Receiving Medications for Opioid Use Disorder

EXPERIMENTAL

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

Interventions

Empowering Pregnant Women and People Receiving Medications for Opioid Use Disorder BEHAVIORAL

Two-pronged intervention model: 1) behavioral intervention utilizing interoceptive exposures and cognitive behavioral therapy for insomnia and, 2) mobile application that facilitates medication adherence.

Also known as: EMPWR

Empowering Pregnant Women and People Receiving Medications for Opioid Use Disorder

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: 26 pregnant individuals will be recruited to participate in this study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

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

Location

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

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor-Faculty

Study Record Dates

• First Submitted: July 3, 2024
• First Posted: July 11, 2024
• Study Start: August 6, 2024
• Primary Completion: January 13, 2026
• Study Completion: January 13, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)