CompletedNot Applicable

MOM NEST Study: Maternal Opioid Medication: Naltrexone Efficacy Study

United States46 participantsStarted 2018-12-01

Plain-language summary

This is a multi-center prospective comparative cohort study examining the safety, efficacy, pharmacokinetics, and pharmacogenomics of naltrexone for pregnant women with opioid use disorder. Pregnancy, delivery, and maternal and infant outcomes to 12 months post-delivery will be examined and compared with a cohort treated with buprenorphine/naloxone.

Who can participate

Age range18 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Pregnant women between 6 - 30 6/7 weeks gestation, receiving prenatal care at Boston Medical Center (BMC) or the University of North Carolina (UNC) * Plan to deliver infant at BMC or UNC * Diagnosis of opioid use disorder (OUD) or alcohol use disorder (AUD) in the current pregnancy on prescribed oral or extended-release naltrexone; or buprenorphine/naloxone for the treatment of OUD * English speaking * Singleton pregnancy Exclusion Criteria: * OUD on prescribed methadone, or no maintenance medication * OUD on Subutex formulation of buprenorphine * Severe psychiatric illness or cognitively impairing ability to provide informed consent * Current maternal incarceration * Women who present for care \>31 0/7 weeks * Multiple gestation pregnancy

What they're measuring

Maternal drug use relapse

Timeframe: up to 12 months post-delivery

Trial details

NCT IDNCT03718104

SponsorBoston Medical Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-05-08

View on ClinicalTrials.gov More Opioid-use Disorder trials