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

Launched by MEDICAL UNIVERSITY OF SOUTH CAROLINA · May 23, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring how effective a new type of therapy combined with technology is for pregnant individuals who are being treated for opioid use disorder with a medication called buprenorphine. Participants will be randomly assigned to either receive this therapy—which includes several therapy sessions and access to a mobile app—or to a standard method of medication monitoring, where they will simply track their medication use for two months. Throughout the study, all participants will fill out questionnaires about their experience and will have their medication counted at random times to ensure they're staying on track. The study will last between 8 to 12 months, depending on when participants join.

To take part in the trial, individuals need to be currently pregnant (between 13 and 32 weeks along), between the ages of 18 and 45, and must have a prescription for buprenorphine for opioid use disorder. Unfortunately, some people may not be eligible, such as those with certain high-risk pregnancy conditions or those who are currently experiencing severe mental health issues. The hope is that this study will help find better ways to support pregnant individuals who are dealing with opioid use disorder.

Gender

FEMALE

Eligibility criteria

• 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.