Technology-enhanced support for pregnant individuals using buprenorphine for opioid use disorder
EMPWR Pilot Trial: Treatment Retention in Medication for Opioid Use Disorder Among Pregnant and Postpartum Women
This study is testing a new support program that uses a mobile app and therapy to help pregnant people stick to their buprenorphine treatment for opioid use disorder.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 26 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Medical University of South Carolina Academic / other |
| Locations | 1 site (Charleston, South Carolina) |
| Trial ID | NCT06496230 on ClinicalTrials.gov |
What this trial studies
This study evaluates a technology-enhanced behavioral intervention designed to improve retention and adherence to buprenorphine treatment among pregnant individuals with opioid use disorder. Participants will engage in therapy sessions during pregnancy and postpartum, supplemented by a mobile application that provides medication reminders and tracks adherence. The intervention aims to address factors that contribute to treatment dropout, such as anxiety and sleep issues. Participants will also complete questionnaires and provide medication counts throughout the study duration of 5-9 months.
Who should consider this trial
Good fit: Ideal candidates are pregnant individuals under 33 weeks gestation with a history of opioid use disorder and a prescription for buprenorphine.
Not a fit: Patients with high-risk pregnancies, current psychotic symptoms, or those who are incarcerated may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve treatment retention and reduce the risk of overdose for pregnant and postpartum individuals with opioid use disorder.
How similar studies have performed: Other studies have shown promise in using technology to enhance treatment adherence in similar populations, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Charleston, South Carolina
- Medical University of South Carolina — Charleston, South Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Sara Witcraft — Medical University of South Carolina
- Study coordinator: Maham Dilawar
- Email: dilawarm@musc.edu
- Phone: 843-214-4496
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.