Actively Recruiting

Phase Not Applicable
Age: 18Years - 45Years
FEMALE
NCT06999811

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

Age: 18Years - 45Years
FEMALE

Eligibility Criteria

Eligible

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
Not Eligible

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

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