Methadone versus buprenorphine in pregnant addicts: a double-blind, double-dummy comparison study

Abstract

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.