Using buprenorphine instead of methadone — the current standard of care — to treat opioid-dependent pregnant women may result in healthier babies, suggests new findings from an international team led by Johns Hopkins researchers and published in the Dec. 9 issue of the New England Journal of Medicine.
Babies born to mothers taking buprenorphine instead of methadone to counter heroin and/or prescription opioid addiction were likely to need less morphine to deal with drug withdrawal symptoms, spent half as much time in the hospital after delivery and recovered from neonatal abstinence syndrome in half as much time, the study found. Neonatal abstinence syndrome, caused when a fetus is exposed to heroin and/or prescription opioids in the womb, can cause hyperirritability and autonomic nervous system dysfunction, often requiring medication and extended hospital stays for babies born with it.
“In newborns, buprenorphine produces a milder withdrawal than methadone,” says study leader Hendree Jones, Ph.D., a professor of psychiatry and behavioral sciences at the Johns Hopkins University School of Medicine. “Our results support the use of buprenorphine as the treatment of choice for opioid dependence in pregnant women.”
“The use of buprenorphine as an alternative treatment for opioid dependence during pregnancy had not been well studied,” she adds, “making this research important in showing that buprenorphine is a better treatment option than methadone.”
Jones cautions that buprenorphine is not for every opioid-dependent pregnant woman. Future research will focus on which drug is right for which type of patient, she says.
The study, an eight-site, double-blind, randomized, controlled trial titled The Maternal Opioid Treatment: Human Experimental Research (MOTHER) project, compared buprenorphine and methadone in the comprehensive care of 175 opioid-dependent women, ages 18 to 40, who were six to 30 weeks’ pregnant.
Although not specifically FDA approved for such use, methadone, a synthetic opiate, is the accepted and recommended treatment for opioid dependence during pregnancy. Patients — including pregnant women — are prescribed methadone in an effort to keep them away from dangerous and illegal street drugs, including heroin, and the risky life issues associated with procuring and taking illegal drugs. Buprenorphine, a newer compound, is comparable to methadone, and both create similar side effects and outcomes for the mother.
Study participants received extensive prenatal and postnatal care and monitoring. Their care plans included psychological evaluations, blood work, sonograms, daily clinic visits, weekly questionnaires, a non-stress test, case management, and group and individual counseling. The mothers and newborns also were monitored for 28 days following delivery.
Other Johns Hopkins researchers on the study include Donald Jasinski, M.D.; Michael Fingerhood, M.D.; Robert Dudas, M.D.; Cheryl Harrow, NP; Lauren M. Jansson, M.D.; Lorraine Milio, M.D.; Eric Strain, M.D.; George Bigelow, Ph.D.; Connie Lowery, RN; Iona Johnson; Mary Bailes, LCPC; Martha Velez, M.D.; Michelle Tuten, LCSW-C; Vickie Walters, LCSW-C; Jim Monolakis, Pharm.D.; Johns Hopkins Bayview Behavioral Pharmacology Research Unit Pharmacy and Nursing staff; JHBMC Center for Addiction and Pregnancy staff; JHBMC Labor and Delivery staff; JHBMC Newborn Nursery and postpartum staff and JHBMC Neonatal Intensive Care Unit staff.
The study was supported by the National Institute on Drug Abuse.
Johns Hopkins Bayview Medical Center, located in Baltimore, Md., is a full-service, Joint Commission-accredited academic medical center. Among the wide range of services offered are an area-wide trauma center and the state’s only regional adult burn center. Founded in 1773, our 560-bed facility features several centers of excellence including stroke, geriatrics, joint replacement, wound care and bariatrics, to name a few. As part of the Johns Hopkins Health System, our physicians hold full-time faculty positions at the Johns Hopkins University School of Medicine. For more information, visit www.hopkinsbayview.org.
