November 12, 2004

Study examines new option for babies born addicted to narcotics

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Lynette Gillis, M.D.

Study examines new option for babies born addicted to narcotics

Researchers in the schools of Medicine and Nursing are teaming up on a new study designed to determine whether a new option could mean less severe withdrawal symptoms for the estimated 350,000 babies reportedly born addicted to narcotics each year.

The research is part of a multi-center, national study at eight sites over five years, funded by the National Institute on Drug Abuse, a division of the National Institutes of Health. Peter R. Martin, M.D., professor of Psychiatry and Pharmacology and director of the Division of Addiction Medicine, and Karen D'Apolito, Ph.D., R.N., assistant professor of Nursing and director of the Neonatal Nurse Practitioner Program at VUSN, are co-principal investigators on the project.

“Right now, pregnant women who have an opioid addiction are treated with methadone. Currently, this is the standard treatment for opioid dependency during pregnancy and the safest available option for newborns, because it reduces drug use by women during pregnancy and prevents potential miscarriage,” said D'Apolito.

But, she said, the current treatment using methadone has not proven to be the best option for the newborns. “After birth, the babies have severe withdrawal signs and symptoms. In some cases, seizures may develop. These babies require pharmacologic treatment that prolongs hospitalization,” D'Apolito added.

D'Apolito and Martin will set out to prove what a pilot study at Johns Hopkins University Medical Center suggests — that giving pregnant women buprenorphine instead of methadone could offer a better outcome for newborns. The preliminary research, involving 309 babies in uncontrolled studies and case reports, showed newborns treated with buprenorphine may experience milder withdrawal symptoms than babies treated with methadone after delivery. “It may be a good thing for the baby in utero and also great for the mom,” D'Apolito said. “She eats better, feels better, and can stop using illicit drugs.”

Buprenorphine may prove to be a better choice for both the mother and child. “We're treating two for the price of one,” Martin said. “This is something we can do to help the offspring and perhaps help the women as well,” he added.

Buprenorphine has been approved for use in women who are not pregnant, but researchers said this study could help encourage Food and Drug Administration approval for use of the drug for opioid addiction during pregnancy.

The double-blind, double-dummy, randomized control trial will involve giving each participant two medications. In some cases, participants will receive buprenorphine and a placebo, or methadone and a placebo. Methadone is a liquid taken by mouth and buprenorphine is a tablet. So each person in the study will get a liquid and a tablet, but no one associated with the study will know which participant is getting which medication.

“We'll look at the severity of withdrawal in babies, the number of babies that require treatment for withdrawal, and in those babies who are treated, we'll look at how long they have to be treated, the length of their hospital stay, and growth parameters,” said D'Apolito.

The project team also includes: Stelian Paul Bodea-Barothi, M.D., assistant professor of Psychiatry; Barbara Engelhardt, M.D., associate professor of Pediatrics, Division of Neonatology; Cornelia Graves, M.D., interim director of Maternal Fetal Medicine, associate professor of Obstetrics and Gynecology, and assistant dean for Diversity in Medical Education; Christopher Greeley, M.D., assistant professor of Pediatrics; the VUSN Nurse-Midwifery Faculty; the Middle Tennessee Treatment Center; the Vanderbilt Addiction Center; and the High-Risk Prenatal Unit.

VUMC hopes to recruit 60 pregnant women to combine results with hundreds of other research subjects at the other seven locations across the United States and abroad. Enrollment is expected to begin by the end of the year. For more information call: 343-7607.