Babies born into the world addicted to drugs because of their mother's dependence on pain medication, or opioids, may be weaned off the substance more comfortably, with a shorter hospital stay and at a reduced cost, if the mother receives a new treatment option during pregnancy.
A New England Journal of Medicine study published Dec. 9, co-authored by Vanderbilt's Peter Martin, M.D., director of the Division of Addiction Psychiatry, found that the newer buprenorphine is at least as good for both mother and child as the standard care methadone, when both were combined with comprehensive care treatment of opioid dependence in pregnant women.
"The baby comes into the world addicted to what the mother was taking," Martin said. "And everyone who comes in touch with these unfortunate babies realizes that they are very uncomfortable and incessantly restless.
"From this study we can say that both the mothers and the babies did equally well taking buprenorphine or methadone.
"However, we demonstrated a statistically significant improvement above the standard of care in important outcomes in the babies of mothers who received buprenorphine during the pregnancy compared to those who were administered methadone," he said.
The eight site, international, double-blind, double-dummy, flexible-dosing, randomized controlled trial is part of the MOTHER project, which stands for Maternal Opioid Treatment: Human Experimental Research.
Buprenorphine had previously not been well studied in pregnancy, although it is now widely prescribed to treat opioid addiction.
"It was only a matter of time before women who were receiving buprenorphine while they become pregnant were faced with the decision to continue it or change to methadone, the standard of care," Martin said.
"For this reason, it was considered very important to determine whether buprenorphine was at least as safe as methadone, so that doctors would know how to advise their patients."
Study results showed that babies of mothers who received buprenorphine compared to those who received methadone throughout pregnancy needed significantly less morphine to treat their neonatal abstinence syndrome, had shorter hospital stays (10 days vs. 17.5 days), and shorter duration of treatment for neonatal abstinence syndrome (4.1 days vs. 9.9. days).
The authors state that improved treatment options should reduce the public health and medical costs associated with the treatment of neonates exposed to opioids, estimated at $70.6 million to $112.6 million in 2009 in the United States.
The research was funded through multiple RO1 grants awarded to investigators at each site, a special NIH funding mechanism that allows large clinical trials to examine geographic and other diversities.
Martin's co-principal investigator at Vanderbilt is Karen D'Apolito, Ph.D., professor of Nursing. Other Vanderbilt investigators include Mavis Schorn, Ph.D., associate professor of Nursing; Joe Gigante, M.D., associate professor of Pediatrics; Barbara Engelhardt, M.D., associate professor of Pediatrics, Karen Starr, M.S.N., R.N., assistant professor of Psychiatry, and Meg Benningfield, M.D., assistant professor of Psychiatry.
- Hendrιe E. Jones, Karol Kaltenbach, Sarah H. Heil, Susan M. Stine, Mara G. Coyle, Amelia M. Arria, Kevin E. O'Grady, Peter Selby, Peter R. Martin, Gabriele Fischer. Neonatal Abstinence Syndrome after Methadone or Buprenorphine Exposure. New England Journal of Medicine, 2010; 363 (24): 2320 DOI: 10.1056/NEJMoa1005359
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