Aims. To assess the maternal and fetal acceptability of buprenorphine and n
eonatal abstinence syndrome (NAS) in children born to buprenorphine-maintai
ned mothers. Design and setting. Open-label, flexible dosing, inpatient ind
uction with outpatient maintenance, conducted at the University of Vienna w
ithin the existing pregnancy and drug addiction program. Participants. Fift
een opioid-dependent pregnant women. Intervention. Sublingual buprenorphine
tablets (1-10 mg/day). Measurements. Mothers: withdrawal symptoms (Wang Sc
ale), nicotine dependence (Fagerstrom Scale: FTQ) and urinalysis. Neonates:
birth outcome and NAS (Finnegan Scale). Findings. All subjects were opioid
-, nicotine- and cannabis-dependent. Buprenorphine teas well tolerated duri
ng induction (Wang Score less than or equal to 4) and illicit opioid use wa
s negligible (91% opioid-negative), All maternal, fetal and neonatal safety
laboratory measures were within normal limits or not of clinical significa
nce. Mean birth outcome measures including gestational age at delivery (39.
6 +/- 1.5 weeks), Apgar scores (1 min = 8.9; 5 min = 9.9; and 10 min = 10),
birth weight (3049 +/- 346 g), length (49.8 +/- 1.9 cm) and head circumfer
ence (34.1 +/- 1.8 cm) were within normal limits. The NAS was absent, mild
(without treatment) and moderate (with treatment) in eight, four and three
neonates, respectively. The mean duration of NAS was 1.1 days. Conclusions.
Buprenorphine appears to be well accepted by mother and fetus, and associa
ted with a low incidence of NAS. Further investigation of buprenorphine as
a maintenance agent for opioid-dependent pregnant women is needed.