The MOTHER trial: babies exposed to buprenorphine needed far less treatment for withdrawal than with methadone
175 pregnant women with opioid dependence were randomised to buprenorphine or methadone. Buprenorphine-exposed newborns needed 1.1 mg v 10.4 mg morphine and 10 v 17.5 days in hospital. More women stopped buprenorphine.
Well-supported by good-quality research. how we score evidence
Caveat on this rating: Newborn benefits are among women who stayed on treatment; more women discontinued buprenorphine (33 v 18 percent).
The randomised trial that changed how opioid dependence is treated in pregnancy, with its main trade-off stated.
Significant findings
Jones and colleagues (New England Journal of Medicine, 2010) ran a double-blind, double-dummy, flexible-dose randomised trial at eight international sites, comparing buprenorphine with methadone in the comprehensive care of 175 pregnant women with opioid dependence. Among 131 newborns whose mothers stayed on their assigned treatment to the end of pregnancy (58 buprenorphine, 73 methadone), the buprenorphine group "required significantly less morphine (mean dose, 1.1 mg vs. 10.4 mg; P<0.0091), had a significantly shorter hospital stay (10.0 days vs. 17.5 days, P<0.0091), and had a significantly shorter duration of treatment for the neonatal abstinence syndrome (4.1 days vs. 9.9 days, P<0.003125)". There were no significant differences in the other primary outcomes, including the number of babies needing treatment, or in maternal or neonatal adverse events.
The authors concluded the results "are consistent with the use of buprenorphine as an acceptable treatment for opioid dependence in pregnant women." The trial was funded by the US National Institute on Drug Abuse (NCT00271219).
The other direction
More women stopped treatment on buprenorphine: 28 of 86 (33 percent) against 16 of 89 (18 percent) on methadone. The newborn advantages come from those who stayed on treatment, so they apply to women who can stay on buprenorphine. The number of newborns needing any withdrawal treatment did not differ significantly.
What this does not show
It does not say either medicine is wrong in pregnancy; both were given within comprehensive care. It is not a reason to switch or stop a medicine during pregnancy; any change is planned with the prescriber and obstetric team.
Worth asking
If I am pregnant or planning to be, which medicine and dose would we use, and what support comes with it?
Source
Neonatal abstinence syndrome after methadone or buprenorphine exposure — Jones HE, Kaltenbach K, Heil SH, Stine SM, Coyle MG, Arria AM, O'Grady KE, Selby P, Martin PR, Fischer G (2010)
Top-tier peer-reviewed journal
Read the source: https://doi.org/10.1056/NEJMoa1005359
DOI: 10.1056/NEJMoa1005359
How this was scored
- Study design
- Randomised controlled trial
- Funding
- Independently funded
- Published in
- Top-tier peer-reviewed journal
- Sample size
- 175
- Preregistered
- Yes
- Conflicts disclosed
- not recorded
- Independent of proponent
- not recorded
- Retracted
- No
Read the full scoring rubric, including what it can't tell you.
Published October 21, 2026.
Questions
How strong is the evidence behind this?
veisund rates this source "strong evidence". Well-supported by good-quality research. It scores 80 out of 100 on our published rubric. One caveat travels with that badge: Newborn benefits are among women who stayed on treatment; more women discontinued buprenorphine (33 v 18 percent). The score is calculated from recorded facts about the source — study design, funding, publication venue, sample size, preregistration — not typed in by an editor.
What is the source for this?
Neonatal abstinence syndrome after methadone or buprenorphine exposure — Jones HE, Kaltenbach K, Heil SH, Stine SM, Coyle MG, Arria AM, O'Grady KE, Selby P, Martin PR, Fischer G (2010). Published in: Top-tier peer-reviewed journal. DOI: 10.1056/NEJMoa1005359. The full source is linked on this page so you can read it yourself.
Who paid for this research, and does that matter?
Study design: Randomised controlled trial. Funding: Independently funded. Independence from the proponent is not recorded. Industry sponsorship is one of the most reliably measured biases in medicine, which is why funding carries real weight in the score rather than sitting in a footnote.
Is this medical advice?
This is information to bring to your prescriber, not medical advice and not a reason to change anything on your own. Nothing here is an instruction to stop or reduce a medication. If you are in crisis, call or text 988.
This is information to bring to your prescriber, not medical advice and not a reason to change anything on your own. Nothing here is an instruction to stop or reduce a medication. If you are in crisis, call or text 988.