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StudyPregnancy and breastfeeding2019

Wachman 2019: naltrexone vs buprenorphine in pregnancy, a small pilot

Wachman EM, Saia K, Miller M, et al. Naltrexone treatment for pregnant women with opioid use disorder compared with matched buprenorphine control subjects

What it found

None of the babies of 6 women treated with naltrexone in pregnancy were diagnosed with neonatal abstinence syndrome (newborn opioid withdrawal), compared with 92% of babies of 13 women on buprenorphine, and they had shorter hospital stays (3.2 vs 10.9 days). The study was very small and not randomized, so it shows a link, not proof.

Newborn withdrawal diagnosed, buprenorphine group
92%
Hospital stay, naltrexone-exposed babies (mean)
3.2 days
Hospital stay, buprenorphine-exposed babies (mean)
10.9 days
Mothers who smoked, buprenorphine vs naltrexone
92% vs 33%

What they tested

This pilot study looked back at records from one center between 2017 and 2019. It compared 6 mothers and babies where the mother took naltrexone (NTX) for opioid use disorder during pregnancy with 13 where the mother took buprenorphine (BUP).

The researchers compared opioid misuse during pregnancy and up to 6 months after delivery, delivery outcomes, gestational age, birth weight, Apgar scores (a quick check of a newborn's health), neonatal intensive care admissions and neonatal abstinence syndrome.

What they found

Mothers and babies in the two groups were similar, except that cigarette smoking was more common in the buprenorphine group (92% vs 33%).

None of the women on naltrexone had documented opioid misuse, against 23% of those on buprenorphine, a difference that was not statistically significant (P = 0.52).

No naltrexone-exposed babies were diagnosed with neonatal abstinence syndrome, against 92% of buprenorphine-exposed babies. 46% of the buprenorphine-exposed babies needed treatment for it, against 0% in the naltrexone group.

Naltrexone-exposed babies had shorter hospital stays, a mean of 3.2 vs 10.9 days.

Limits

  • Only 6 women took naltrexone, far too few to detect uncommon problems.
  • It was a look back at records from one center, not a randomized trial, so the two groups may have differed in ways the study couldn't measure.
  • The groups weren't fully alike: far more mothers smoked in the buprenorphine group.
  • It didn't look at the longer-term health of mothers or children, which the authors say larger studies need to examine.

What it means if you're considering naltrexone

Naltrexone in pregnancy has been little studied, and this small pilot found good early outcomes for the babies of women who took it. With only 6 naltrexone pregnancies at one center, it can't establish safety, and the authors call for larger multicenter studies of long-term safety and effectiveness.

Frequently asked questions

Is naltrexone safe during pregnancy?

There isn't enough evidence to say. In this pilot of 6 women on naltrexone, no babies had newborn withdrawal and hospital stays were shorter than with buprenorphine, but the study was far too small to judge safety.

The paper

Wachman EM, Saia K, Miller M, et al. Naltrexone treatment for pregnant women with opioid use disorder compared with matched buprenorphine control subjects. Clin Ther. 2019;41(9):1681-1689. doi:10.1016/j.clinthera.2019.07.003

Read the paperdoi:10.1016/j.clinthera.2019.07.003

We wrote this page from the paper's published abstract, and the study's numbers here come from there. Updated October 17, 2026.

Medical disclaimer

This page is for information only and is not medical advice, diagnosis, or treatment. Don't start, stop, or change any medicine — including naltrexone — without your prescriber. Naltrexone must not be used by people taking opioid pain medicines, people dependent on opioids, or people in opioid withdrawal (FDA label). In an emergency call 911; for crisis support call or text 988. Full medical disclaimer.