Status:
ACTIVE_NOT_RECRUITING
Open Trial of Technology-Enhanced Behavioral Intervention for Buprenorphine Retention in Pregnant and Postpartum People
Lead Sponsor:
Medical University of South Carolina
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Opioid Use Disorder
Pregnancy Related
Eligibility:
FEMALE
18-45 years
Phase:
EARLY_PHASE1
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...
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 us...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 6 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2026
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT06496230
Start Date
August 6 2024
End Date
January 31 2026
Last Update
July 11 2025
Active Locations (1)
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1
Medical University of South Carolina
Charleston, South Carolina, United States, 29403