Trial reportAddiction (Abingdon, England)2011
Randomized controlled trials in pregnancy: scientific and ethical aspects. Exposure to different opioid medications during pregnancy in an intra-individual comparison.
Trial report in Addiction (Abingdon, England), 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
13 citing papers in PubMed, 1 synthesis or guideline pooled it, 32 citations in OpenAlex.
- Psychosocial interventions for pregnant women in outpatient illicit drug treatment programs compared to other interventions.The Cochrane database of systematic reviews · 2015Pooled it
- Influence of site differences between urban and rural American and Central European opioid-dependent pregnant women and neonatal outcome characteristics.European addiction research · 2012Trial
- Safety in treatment: Classical pharmacotherapeutics and new avenues for addressing maternal depression and anxiety during pregnancy.Pharmacological reviews · 2025Review
- Predicting completion of clinical trials in pregnant women: Cox proportional hazard and neural network models.Clinical and translational science · 2022Article
- Medication-assisted treatment vs. detoxification for women who misuse opioids in pregnancy: Associations with dropout, relapse, neonatal opioid withdrawal syndrome (NOWS), and childhood sexual abuse.Addictive behaviors reports · 2020Article
- Factors associated with treatment retention in pregnant women with opioid use disorders prescribed methadone or electing non-pharmacological treatment.Women & health · 2020Article
- Discovering major opioid-related research themes over time: A text mining technique.AMIA Joint Summits on Translational Science proceedings. AMIA Joint Summits on Translational Science · 2019Article
- Evaluation of the vaginal flora in pregnant women receiving opioid maintenance therapy: a matched case-control study.BMC pregnancy and childbirth · 2016Article
- Maternal Substance Use and Neonatal Abstinence Syndrome: A Descriptive Study.Maternal and child health journal · 2015Article
- Buprenorphine use in pregnant opioid users: a critical review.CNS drugs · 2013Review
- Buprenorphine treatment of opioid-dependent pregnant women: a comprehensive review.Addiction (Abingdon, England) · 2012Review
- Buprenorphine implant for opioid addiction.Pain management · 2012Article
- Opioid dependent and pregnant: what are the best options for mothers and neonates?Obstetrics and gynecology international · 2012Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 4 institutions in 2 countries.
Funding
Abstract
backgroundChronic medical conditions such as opioid dependence require evidence-based treatment recommendations. However, pregnant women are under-represented in clinical trials. We describe the first within-subject comparison of maternal and neonatal outcomes for methadone- versus buprenorphine-exposed pregnancies. Although methadone is the established treatment of pregnant opioid-dependent women, recent investigations have shown a trend for a milder neonatal abstinence syndrome (NAS) under buprenorphine. However, it is not only the choice of maintenance medication that determines the occurrence of NAS; other factors such as maternal metabolism, illicit substance abuse and nicotine consumption also influence its severity and duration and represent confounding factors in the assessment of randomized clinical trials. CASE SERIES DESCRIPTION: Three women who were part of the European cohort of a randomized, double-blind multi-center trial with a contingency management tool [the Maternal Opioid Treatment: Human Experimental Research (MOTHER) study], each had two consecutive pregnancies and were maintained on either methadone or buprenorphine for their first and then the respective opposite, still-blinded medication for their second pregnancy. Birth measurements, the total neonatal abstinence score, the total amounts of medication used to treat NAS and the days of NAS treatment duration were assessed.
resultsBoth medications were effective and safe in reducing illicit opioid relapse and avoiding preterm labor. Methadone maintenance yielded to a significantly higher neonatal birth weight. Data patterns suggest that buprenorphine exposure was associated with lower neonatal abstinence syndrome (NAS) scores. Findings from this unique case series are consistent with earlier reports using between-group analyses.
conclusionsBuprenorphine has the potential to become an established treatment alternative to methadone for pregnant opioid-dependent women. Under special consideration of ethical boundaries, psychopharmacological treatment during pregnancy must be addressed as an integral part of clinical research projects in order to optimize treatment for women and neonates.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.