Buprenorphine versus methadone in the treatment of pregnant opioid-dependent patients: Effects on the neonatal abstinence syndrome

Department of Gynecology & Obstetrics, Johns Hopkins University, Baltimore, Maryland, United States
Drug and Alcohol Dependence (Impact Factor: 3.42). 08/2005; 79(1):1-10. DOI: 10.1016/j.drugalcdep.2004.11.013
Source: PubMed


This study was designed to compare the neonatal abstinence syndrome (NAS) in neonates of methadone and buprenorphine maintained pregnant opioid-dependent women and to provide preliminary safety and efficacy data for a larger multi-center trial. This randomized, double-blind, double-dummy, flexible dosing, parallel-group controlled trial was conducted in a comprehensive drug-treatment facility that included residential and ambulatory care. Participants were opioid-dependent pregnant women and their neonates. Treatment involved daily administration of either sublingual buprenorphine or oral methadone using flexible dosing of 4-24 mg or 20-100 mg, respectively. Primary a priori outcome measures were: (1) number of neonates treated for NAS; (2) amount of opioid agonist medication used to treat NAS; (3) length of neonatal hospitalization; and (4) peak NAS score. Two of 10 (20%) buprenorphine-exposed and 5 of 11 (45.5%) methadone-exposed neonates were treated for NAS (p=.23). Total amount of opioid-agonist medication administered to treat NAS in methadone-exposed neonates was three times greater than for buprenorphine-exposed neonates (93.1 versus 23.6; p=.13). Length of hospitalization was shorter for buprenorphine-exposed than for methadone-exposed neonates (p=.021). Peak NAS total scores did not significantly differ between groups (p=.25). Results suggest that buprenorphine is not inferior to methadone on outcome measures assessing NAS and maternal and neonatal safety when administered starting in the second trimester of pregnancy.

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    • "During this same period, mean hospital charges for treatment of neonates with NAS increased more than 35%, from $39,400 to $53,400 (Patrick et al., 2012). However, the relationship between maternal buprenorphine dose and either neonatal abstinence syndrome (NAS) incidence or severity has been inconsistent (Jones et al., 2005; Lejeune et al., Please cite this article in press as: Jones, H.E., et al., Neonatal outcomes and their relationship to maternal buprenorphine dose during pregnancy. Drug Alcohol Depend. "
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    ABSTRACT: Buprenorphine pharmacotherapy for opioid-dependent pregnant women is associated with maternal and neonatal outcomes superior to untreated opioid dependence. However, the literature is inconsistent regarding the possible existence of a dose-response relationship between maternal buprenorphine dose and neonatal clinical outcomes. The present secondary analysis study (1) examined the relationship between maternal buprenorphine dose at delivery and neonatal abstinence syndrome (NAS) peak score, estimated gestational age at delivery, Apgar scores at 1 and 5min, neonatal head circumference, length, and weight at birth, amount of morphine needed to treat NAS, duration of NAS treatment, and duration of neonatal hospital stay and (2) compared neonates who required pharmacotherapy for NAS to neonates who did not require such pharmacotherapy on these same outcomes, in 58 opioid-dependent pregnant women receiving buprenorphine as participants in a randomized clinical trial. (1) Analyses failed to provide evidence of a relationship between maternal buprenorphine dose at delivery and any of the 10 outcomes (all p-values>.48) and (2) significant mean differences between the untreated (n=31) and treated (n=27) for NAS groups were found for duration of neonatal hospital stay and NAS peak score (both p-values<.001). (1) Findings failed to support the existence of a dose-response relationship between maternal buprenorphine dose at delivery and any of 10 neonatal clinical outcomes, including NAS severity and (2) that infants treated for NAS had a higher mean NAS peak score and, spent a longer time in the hospital than did the group not treated for NAS is unsurprising.
    Full-text · Article · Nov 2013 · Drug and alcohol dependence
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    • "et al . ( 2006 ) investigated 18 women with mean doses of 45 . 7 mg methadone and 13 . 5 mg buprenorphine at delivery . In both studies , methadone and buprenorphine showed comparable data regarding neonatal outcomes . In addition , a significantly shorter length of hospital stay for buprenorphine - exposed neonates ( p = 0 . 021 ) was reported by Jones et al . ( 2005 ) . The US sample had low rates of illicit substance use observed in both groups prior to delivery , referring to the efficacy of escalating voucher incentives ( " contingency management " ) for providing negative urine screens as well as negative ethanol - breath screens . This was not part of the design in the Viennese report ( Fische"
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    ABSTRACT: Objectives. Lessons learned in research and treatment of opioid dependence demonstrate the need to include pregnant women in clinical trials. Methods. Two double-blind, double-dummy, randomized controlled trials comparing buprenorphine and methadone in opioid-dependent pregnant women were conducted. In both studies, participants received voucher-based incentives for attendance and completion of study assessments. In the MOTHER trial, participants additionally received escalating voucher incentives for drug-free urine samples. Neonatal abstinence syndrome was treated with oral morphine solution based on standardized modified Finnegan scores. Results. After a mean treatment period of 13.79 weeks in the Pilot study (PS, n = 18) and 20.78 weeks in the MOTHER-trial (MT, n = 41), respectively (p < 0.001), PS patients delivered at mean doses of 14.00mg buprenorphine/52.50mg methadone and MT participants at 13.44mg buprenorphine/63.68mg methadone. Nonsignificant differences regarding dropout rates were found (22% in PS versus 10% in MT), but dropout was significantly earlier in the MT (p = 0.013). Significantly higher rates of concomitant consumption of opioids and benzodiazepines occurred in the PS compared with the MT (p < 0.001), however, with no significant differences in neonatal data between both settings. Conclusions. Early treatment enrolment combined with contingency management contributes to reduced illicit drug use throughout pregnancy, surprisingly without influencing neonatal outcome parameters.
    Full-text · Article · Jan 2013 · Human Psychopharmacology Clinical and Experimental
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    • "In all three studies, MMT was provided from specialized clinics and BMT was provided mainly by general practitioners. Results of randomized clinical trials (RTCs) indicate that BMT yields a milder abstinence syndrome for the neonate than does MMT (Fischer et al., 2006; Jones et al., 2005, 2010). The MOTHER study (Jones et al., 2010), an international multi-center RCT, found no significant difference in the incidence of NAS, but in the prenatally buprenorphineexposed condition, the duration of NAS-treatment was shorter. "
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    ABSTRACT: Background: In Norway, most opioid-dependent women are in opioid maintenance treatment (OMT) with either methadone or buprenorphine throughout pregnancy. The inclusion criteria for both medications are the same and both medications are provided by the same health professionals in any part of the country. International studies comparing methadone and buprenorphine in pregnancy have shown differing neonatal outcomes for the two medications. Method: This study compared the neonatal outcomes following prenatal exposure to either methadone or buprenorphine in a national clinical cohort of 139 women/neonates from 1996 to 2009. Results: After adjusting for relevant covariates, buprenorphine-exposed newborns had larger head circumferences and tended to be heavier and longer than methadone-exposed newborns. The incidence of neonatal abstinence syndrome (NAS) and length of treatment of NAS did not differ between methadone- and buprenorphine-exposed newborns. There was little use of illegal drugs and benzodiazepines during the pregnancies. However, the use of any drugs or benzodiazepines during pregnancy was associated with longer lasting NAS-treatment of the neonates. Conclusions: The clinical relevance of these findings is that both methadone and buprenorphine are acceptable medications for the use in pregnancy, in line with previous studies. If starting OMT in pregnancy, buprenorphine should be considered as the drug of choice, due to more favorable neonatal growth parameters. Early confirmation of the pregnancy and systematic follow-up throughout the pregnancy are of importance to encourage the women in OMT to abstain from the use of tobacco, alcohol, illegal drugs or misuse of prescribed drugs.
    Full-text · Article · Jul 2012 · Drug and alcohol dependence
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