Aims To evaluate the efficacy and safety of methadone versus buprenorphine treatment in pregnant opioid-dependent women.
Design Randomized, double-dummy, double-blind, flexible-dosing comparison study.
Setting Addiction Clinic at the Medical University of Vienna, Austria.
Participants Eighteen women were assigned randomly 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.