Actively Recruiting
Technology-Enhanced Therapy vs. Medication Monitoring for Buprenorphine Retention in Pregnant Persons
Led by Medical University of South Carolina · Updated on 2026-04-08
37
Participants Needed
1
Research Sites
153 weeks
Total Duration
On this page
Sponsors
M
Medical University of South Carolina
Lead Sponsor
N
National Institute on Drug Abuse (NIDA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study involves testing how useful a technology-enhanced therapy is for pregnant people prescribed buprenorphine for the treatment of opioid use disorder, compared to medication monitoring. Participants are randomized to one of the conditions. If participants are randomized to receive the therapy, participants will attend four 60-minute therapy appointments during pregnancy with an additional 30-minute therapy session towards the end of pregnancy, and 6 additional monthly postpartum (after childbirth) sessions (0-6 months postpartum). As part of the therapy program, participants will receive access to a mobile application, which will be accessible for the duration of the study. If participants are randomized to medication monitoring, participants will be asked to log each time participants take their medication for two months. All participants will also be asked to complete questionnaires at enrollment and again at 3-month postpartum and 6-months postpartum, and will be contacted randomly throughout the study to perform a medication count. The total duration of the study is between 8-12 months depending on when participants enroll (early second trimester-mid third trimester).
CONDITIONS
Official Title
Technology-Enhanced Therapy vs. Medication Monitoring for Buprenorphine Retention in Pregnant Persons
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Currently pregnant between 13 weeks 0 days and 32 weeks 6 days gestation
- Current opioid use disorder or history of opioid use disorder within the past 3 years
- Confirmed prescription for sublingual buprenorphine (e.g., Suboxone, Subutex, Zubsolv) to treat opioid use disorder
- Living in the United States
- Between 18 and 45 years of age
You will not qualify if you...
- Carrying multiples (twins, triplets, etc.)
- High-risk pregnancy conditions such as active severe nausea, hypertensive disorders (gestational hypertension, preeclampsia), placenta previa, or vaginal bleeding after the first trimester
- Current psychotic symptoms or active suicidal intent
- Cognitive or emotional impairment that prevents providing informed consent
- Incarcerated, pending incarceration, or institutionalized during the study
- Non-English speaking
AI-Screening
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Trial Site Locations
Total: 1 location
1
Medical University of South Carolina
Charleston, South Carolina, United States, 29403
Actively Recruiting
Research Team
M
Morgan Thomas
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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