Is naltrexone (opioid receptor antagonist) safe for managing alcohol cravings in pregnant women?

Naltrexone Use in Pregnancy for Alcohol Cravings

Naltrexone may be considered for pregnant women with alcohol use disorder when psychosocial interventions have failed, as the decision requires careful individualized weighing of the substantial harms of continued alcohol use against the limited but reassuring safety data for naltrexone. 1

Guideline Recommendations

The most recent 2023 EASL (European Association for the Study of Liver) guidelines provide clear direction on this clinical dilemma:

• Medication use to treat alcohol use disorder during pregnancy should be individualized, with disulfiram avoided, and consideration of naltrexone or acamprosate requiring careful weighing of the risks of alcohol use versus medication exposure. 1

• The 2021 AASLD (American Association for the Study of Liver Diseases) guidelines similarly recommend that medication use should be individualized, carefully weighing the risks of alcohol use versus medication exposure. 1

The Critical Context: Alcohol's Devastating Effects

The harms of continued alcohol use during pregnancy are severe and well-established, making this risk-benefit calculation crucial:

• Alcohol use in pregnancy is strongly associated with preterm birth, small for gestational age infants, fetal alcohol spectrum disorder, and fetal alcohol syndrome—all causing long-lasting impairments. 1

• There is no safe level of alcohol consumption during pregnancy; abstinence is the goal. 2

Safety Profile of Naltrexone in Pregnancy

The available evidence, while limited, is reassuring regarding naltrexone's safety:

• Limited human data for naltrexone use during pregnancy did not show fetal abnormalities. 1

• Naltrexone has been used in treatment of women with opioid use disorder without fetal abnormalities noted. 1

• A 2025 scoping review concluded that despite concerns about higher rates of some pregnancy complications, naltrexone appears to be a safer option compared with continued alcohol use during pregnancy. 3

• A 2024 case series of 7 pregnant individuals treated with naltrexone (4 with OUD, 3 with AUD) showed no fetal anomalies, no neonatal opioid withdrawal syndrome, low rates of return to substance use, and reassuring maternal and infant outcomes to 12 months postpartum. 4

• A 2021 review concluded that naltrexone does not appear to be associated with substantial risks of congenital malformations or other serious consequences, and should be considered for pregnant women with AUD given the potential risks of continued alcohol consumption. 5

Clinical Decision Algorithm

When to Consider Naltrexone:

1. First-line approach: Psychosocial treatment remains the primary intervention for alcohol use disorder in pregnancy. 1

2. Consider naltrexone when:

   • Psychosocial interventions have failed 3
   • The pregnant woman has established alcohol use disorder with ongoing drinking 1
   • The risk of continued alcohol exposure to the fetus outweighs the theoretical medication risks 1

3. Avoid naltrexone when:

   • The woman is also using opioids (naltrexone will precipitate withdrawal) 1
   • Abstinence can be achieved through psychosocial means alone 1

Medications to Avoid

Disulfiram is contraindicated in pregnancy due to association with fetal abnormalities. 1, 2

Baclofen should be used with caution as it may accumulate and potentially cause neonatal withdrawal syndrome. 1, 6

Management of Acute Alcohol Withdrawal

If the pregnant woman is stopping high and chronic alcohol intake:

• Low doses of benzodiazepines for the shortest duration may be used to prevent alcohol withdrawal symptoms. 2
• Hospitalization is recommended for management of withdrawal. 2

Critical Pitfalls to Avoid

• Do not withhold naltrexone solely due to pregnancy when continued alcohol use poses greater fetal risk. 3, 5
• Do not use disulfiram under any circumstances in pregnancy. 1
• Do not delay screening for alcohol use—all pregnant women should be screened and referred for management when appropriate. 1
• Do not assume abstinence will be maintained without support—close follow-up is essential. 4

Practical Dosing Considerations

Standard naltrexone dosing is 50 mg orally daily, which has been studied most extensively and shown reasonable tolerability with nausea as the most common side effect. 7

Extended-release intramuscular naltrexone (active for one month) has also been used successfully in pregnant individuals with reassuring outcomes. 4