Buprenorphine-naloxone versus buprenorphine for opioid use disorder during pregnancy: A systematic review and meta-analysis.

Mariano Gallo Ruelas, Gabriela Oliveira Gonçalves Molino, Fernanda Ribeiro de Lima, Eduardo Cerchi Barbosa, Pedro Henrique Costa Matos da Silva, Felipe Bandeira de Melo Guimarães, Arthur Bezerra Cavalcanti Petrucci, Giovanna Hanike Santos da Silva, Ângelo Eduardo Espíndola Sbardelotto, Saulo Bernardo Lança, Alicja Garbacka

Journal: Drug and alcohol dependence 2025;271():112632

PMID: 40073807

Full Text on Elsevier Science View on PubMed

Abstract

BACKGROUND

The standard of care for treating opioid use disorder (OUD) during pregnancy includes either buprenorphine or methadone. Although buprenorphine-naloxone presents an alternative due to the reduced risk of misuse , evidence regarding its impact on pregnancy and infant health remains limited. This systematic review and meta-analysis aims to compare buprenorphine-naloxone vs buprenorphine alone for OUD during pregnancy, assessing gestational and neonatal outcomes.

METHODS

We systematically searched MEDLINE, Embase, and Cochrane Library databases to identify studies comparing buprenorphine-naloxone versus buprenorphine for OUD during pregnancy. The primary outcome assessed was neonatal abstinence syndrome (NAS). Pooled risk ratios (RR) and mean differences (MD) with 95 % confidence intervals (CI) were calculated using R statistical software and quality assessment was performed following Cochrane recommendations.

RESULTS

Six retrospective cohorts were included, encompassing 9348 mother-infant dyads, of whom 38.3 % received buprenorphine-naloxone. NAS requiring treatment (RR 0.77; 95 % CI 0.71-0.84; p < 0.01) and small for gestational age infants (RR 0.86; 95 % CI 0.76-0.98; p = 0.03) were significantly less frequent in the buprenorphine-naloxone group. No significant differences were found between the groups for cesarean delivery (RR 1.04; 95 % CI 0.98-1.11; p = 0.20), low birth weight (RR 1.07; 95 % CI 0.91-1.24; p = 0.41), and preterm delivery (RR 1.07; 95 % CI 0.96-1.21; p = 0.22).

CONCLUSION

Pregnant people treated with buprenorphine-naloxone had neonates with a lower risk of small for gestational age and NAS. Further research is needed to confirm these findings and explore other pregnancy-related and neonatal outcomes.

Address: Department of Medicine, Pontifical Catholic University of Paraná, Curitiba, Brazil. Electronic address: [email protected].; Department of Medicine, Federal University of Health Sciences of Porto Alegre, Porto Alegre, Brazil. Electronic address: [email protected].; Instituto de Investigación Nutricional, Lima, Peru. Electronic address: [email protected].; Department of Medicine, Evangelical University of Goiás, Anápolis, Brazil. Electronic address: [email protected].; Department of Gynecology and Obstetrics, Federal University of Goiás, Goiânia, Brazil. Electronic address: [email protected].; Institute of Psychiatry, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil. Electronic address: [email protected].; Medical Sciences Center, Federal University of Paraíba, João Pessoa, Brazil. Electronic address: [email protected].; Department of Medicine, Catholic University of Pernambuco, Recife, Brazil. Electronic address: [email protected].; Health Sciences Center, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil. Electronic address: [email protected].; Department of Pediatrics, Federal University of São Paulo, São Paulo, Brazil. Electronic address: [email protected].; Institute of Psychiatry and Neurology, Child and Adolescent Psychiatry Clinic, Warsaw, Poland. Electronic address: [email protected].

DOI: 10.1016/j.drugalcdep.2025.112632

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MeSH Terms: Humans, Pregnancy, Female, Opioid-Related Disorders, Pregnancy Complications, Infant, Newborn, Neonatal Abstinence Syndrome, Buprenorphine, Naloxone Drug Combination, Opiate Substitution Treatment, Narcotic Antagonists, Buprenorphine, Pregnancy Outcome