***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: Background : Although concerns arise about the generalizability of results from R and omized Controlled Trials ( RCTs ) , few studies systematic ally examine this issue . Objectives : This study compared the characteristics of 427 opioid-using pregnant women who did ( n = 208 ) and did not consent ( n = 219 ) to enrollment in a multicenter clinical trial of agonist medications ( i.e. , the MOTHER study ) . Methods : Logistic regression models were used to compare consenters and non-consenters to examine the effect of screening variables on the likelihood of consenting . Results : Of nine characteristics examined , most differences did not reach statistical significance . Consenting participants were less likely than non-consenting women to be currently enrolled in a methadone maintenance program ( 74.5 % vs. 84.5 % , p = .01 ) . Conclusion and Scientific Significance : These data show that the recruited sample of drug-dependent pregnant women enrolled in an intensive RCT is representative of the larger population of treated opioid-dependent patients and supports the generalizability of r and omized controlled trials in this population This study was design ed 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 r and omized , 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 BACKGROUND Prior studies have shown an increased vulnerability among males to adverse outcomes during the postnatal period . Most children exposed to opioids and other medications in utero develop neonatal abstinence syndrome ( NAS ) , yet individual predisposition for NAS is poorly understood . OBJECTIVE This investigation examined the role of neonatal sex in the postnatal period for neonates exposed to st and ardized opioid maintenance treatment in utero with a focus on NAS regarding severity , medication requirements , and duration . METHODS This was a secondary analysis of data collected in a prospect i ve r and omized , double-blind , double-dummy , multicenter trial ( MOTHER study ) that examined the comparative safety and efficacy of methadone and buprenorphine during pregnancy . A total of 131 neonates born to opioid-dependent women r and omized at 6 US sites ( n = 74 ) and 1 European site ( n = 37 ) were analyzed . Sex-based differences in birth weight , length , head circumference , NAS duration , NAS severity , and treatment parameters of full-term neonates were assessed . RESULTS Males had a significantly higher birth weight ( P = 0.027 ) and head circumference ( P = 0.017 ) compared with females , with no significant sex difference in rates of preterm delivery . No significant sex-related differences were found for NAS development , severity , or duration , or medication administered , and there were no significant differences in concomitant drug consumption during pregnancy ( P = 0.959 ) . CONCLUSIONS This unique prospect i ve study shows similar postnatal vulnerability for both sexes , suggesting that factors other than sex are the major determinants of clinical ly significant NAS . Clinical Trials.gov identifier : NCT 00271219 AIM To determine the effects of in utero exposure to methadone or buprenorphine on infant neurobehavior . DESIGN Three sites from the Maternal Opioid Treatment : Human Experimental Research ( MOTHER ) study , a double-blind , double-dummy , r and omized clinical trial participated in this sub study . SETTING Medical Centers that provided comprehensive maternal care to opioid-dependent pregnant women in Baltimore , MD , Providence , RI and Vienna , Austria . PARTICIPANTS Thirty-nine full-term infants . MEASUREMENTS The Neonatal Intensive Care Unit ( NICU ) Network Neurobehavioral Scale ( NNNS ) was administered to a subgroup of infants on postpartum days 3 , 5 , 7 , 10 , 14 - 15 and 28 - 30 . FINDINGS While neurobehavior improved for both medication conditions over time , infants exposed in utero to buprenorphine exhibited fewer stress-abstinence signs ( P < 0.001 ) , were less excitable ( P < 0.001 ) and less over-aroused ( P < 0.01 ) , exhibited less hypertonia ( P < 0.007 ) , had better self-regulation ( P < 0.04 ) and required less h and ling ( P < 0.001 ) to maintain a quiet alert state relative to in utero methadone-exposed infants . Infants who were older when they began morphine treatment for withdrawal had higher self-regulation scores ( P < 0.01 ) , and demonstrated the least amount of excitability ( P < 0.02 ) and hypertonia ( P < 0.02 ) on average . Quality of movement was correlated negatively with peak NAS score ( P < 0.01 ) , number of days treated with morphine for NAS ( P < 0.01 ) and total amount of morphine received ( P < 0.03 ) . Excitability scores were related positively to total morphine dose ( P < 0.03 ) . CONCLUSION While neurobehavior improves during the first month of postnatal life for in utero agonist medication-exposed neonates , buprenorphine exposure results in superior neurobehavioral scores and less severe withdrawal than does methadone exposure Patients and methods In order to investigate the effects of exposure to buprenorphine compared with methadone during pregnancy , a prospect i ve multicenter study was conducted in collaboration with maternity hospitals , maintenance therapy centers , and general practitioners involved in addiction care . Ninety pregnant women exposed to buprenorphine and 45 to metadone were selected for the study . Results During pregnancy , some women were exposed to illicit agents : cannabis ( 42 % in the buprenorphine group vs. 58 % in the methadone-treated group ) , heroin ( 17 % vs. 44 % ) , or cocaine ( 3 % vs. 11 % ) . Pregnancies ended in 85 vs. 40 live births , one vs. two stillbirths , two vs. one spontaneous abortion , two vs. one voluntary termination , and one vs. one medical termination in the buprenorphine and the methadone groups , respectively . Newborns had a birth weight of 2,892 ± 506 g ( buprenorphine ) vs. 2,731 ± 634 g ( methadone ) and a body length of 47.6 ± 2.5 cm vs. 47.1 ± 3 cm . 18.8 % vs. 10 % of newborns were delivered before 37 weeks of amenorrhea . Neonatal withdrawal syndrome occurred more frequently in the methadone group ( 62.5 % vs. 41.2 , p = 0.03 ) . After adjustment for heroin exposure in late pregnancy , rates of neonatal withdrawal were no longer different between the methadone and buprenorphine groups . Twenty-one babies ( 84 % ) in the methadone group and 20 ( 57 % ) in the buprenorphine group ( p = 0.03 ) required opiate treatment . Conclusions We did not observe more frequent malformations or cases of withdrawal syndrome in the buprenorphine group than in the methadone-treated group . Buprenorphine appears to be as safe as the currently approved substitute methadone considered to date as the reference treatment for pregnant opioid-dependent women Background : Contingency management ( CM ) has shown promise for treating substance use disorders in pregnant women . Methods : A r and omized clinical trial compared the relative efficacy of three conditions on the measures of opioid and cocaine abstinence and days retained in treatment . A total of 133 pregnant patients attending treatment for substance use disorders were r and omized either to an escalating reinforcement condition , a fixed reinforcement condition , or an attendance control condition . Conditions were compared on drug abstinence rates and days retained in treatment . Results : As expected , the pooled escalating + fixed conditions received a greater total amount of voucher money than the control condition mean [ M = 392.40 ( SE = 40.47 ) vs. 219.74 ( SE = 39.78 ) ] , respectively ; p < .001 . However , the escalating and fixed conditions did not differ on the outcome variables of drug abstinence and treatment retention . Conclusions : The CM conditions examined in the current study did not emerge as superior to the control condition . The lack of significant differences among study conditions may be attributed , in part , to study sample size . Additionally , method ological issues related to the CM intervention may also have compromised outcomes , including delay in reinforcement following the target behavior and limited contact with the reinforcer . Scientific Significance : This study highlights the importance of key CM implementation features , including immediate reinforcement , and adequate access to the reinforcer . It may also be that the reset feature for missing sample s in CM interventions is an essential contingency for promoting behavior change . Trial registration : Clinical Trials.gov identifier : NCT00497068 AIMS To evaluate the efficacy and safety of methadone versus buprenorphine treatment in pregnant opioid-dependent women . DESIGN R and omized , double-dummy , double-blind , flexible-dosing comparison study . SETTING Addiction Clinic at the Medical University of Vienna , Austria . PARTICIPANTS Eighteen women were assigned r and omly to receive either methadone ( n = 9 ) or buprenorphine ( n = 9 ) during weeks 24 - 29 of pregnancy . After dropouts , data were available from 14 cases ( six in the methadone and eight in the buprenorphine group ) . INTERVENTION Sublingual buprenorphine tablets ( 8 - 24 mg/day ) or oral methadone solution ( 40 - 100 mg/day ) , with matched placebos . MEASUREMENTS Mothers : retention in treatment , urine toxicology and nicotine use . Neonates : Routine birth data , neonatal abstinence syndrome ( NAS ) in severity and duration . FINDINGS There was somewhat greater retention in the buprenorphine group but significantly lowered use of additional opioids in the methadone group ( P = 0.047).Neonates : There was earlier onset of NAS in neonates born to the methadone ( mean 60 hours ) than to the buprenorphine groups ( mean 72 hours after last medication ) ; 43 % did not require NAS-treatment with short treatment duration in both groups ( mean 5 days ) . CONCLUSION This preliminary study had limited power to detect differences but the trends observed suggest this kind of research is practicable and that further studies are warranted 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 , r and omized controlled trials ( Pilot study , European sample ( † ) of MOTHER-trial ) 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 assessment s. In the MOTHER trial , participants additionally received escalating voucher incentives for drug-free urine sample s. Neonatal abstinence syndrome was treated with oral morphine solution based on st and ardized 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 14.00 mg buprenorphine/52.50 mg methadone and MT participants at 13.44 mg buprenorphine/63.68 mg methadone . Nonsignificant differences regarding dropout rates were found ( 22 % in PS versus 10 % in MT ) , but dropout was 
    Output:
    
For the mother there was no statistically significant difference ; for the newborns in the buprenorphine group there were significantly fewer serious side effects .
AUTHORS ' CONCLUSIONS We did not find sufficient significant differences between methadone and buprenorphine or slow-release morphineto allow us to conclude that one treatment is superior to another for all relevant outcomes .
While methadone seems superior in terms of retaining patients in treatment , buprenorphine seems to lead to less severe neonatal abstinence syndrome .