SUBSTANCE ABUSE AND TREATMENT
Opioid Dependent Pregnant Women:
Maternal and Neonatal Outcomes with Buprenorphine
By Arthur Falek, Ph.D.
A paper in the June issue of Drug and Alcohol Dependence (63:97-103,
2001) Rolley E. Johnson at Johns Hopkins School of Medicine and
thirteen co-authors reported an apparent effective treatment for
opioid dependent, pregnant women that seems to safeguard the health
of both the mother and her child. It is estimated that in the
United States there are 5,000 to 10,000 infants born to opioid
dependent women each year. Prenatal methadone treatment, introduced
to protect the child from the medical consequences of neonatal
abstinence syndrome (NAS), unfortunately, was found to result
as well in a high incidence of NAS needing extensive treatment
The current publication is focused on another manufactured opiate,
the partial mu agonist buprenorphine. It is based on over twenty
years of findings from many preclinical (animal) studies, ninety-seven
retrospective clinical (human subjects) reports along with a new
prospective study designed to test this pharmacologic agent in
three pregnant, opioid dependent women and their infants. The
findings are that buprenorphine appears to be safe and effective
for both the mother and child.
For the mother, treatment with 8-12 mg. buprenorphine daily in
the latter weeks of pregnancy resulted in little to no neuronal
symptoms of opioid withdrawal. Furthermore, preclinical findings
indicated that buprenorphine would not impair her fertility or
reproductive function while subjective findings by the three women
showed minimal levels of heroin craving.
As to buprenorphine in breast milk, it would seem that while
the plasma to breast milk ratio is 1, the amount of breast milk
absorbed by the infant appears to be low. Therefore, the authors
suggest buprenorphine may be advantageous over other opioid agonist
medications to treat this special population. For the child, buprenorphine
in combination with comprehensive prenatal care resulted in short
term hospitalization, ~ 4 ½ days, to treat a relatively
mild NAS evidenced by tremors, hyperactive neuropsychological
responses and shortened sleep after feeding. No pharmacological
treatments were needed for the three infants. Although in the
three study infants NAS signs were present within the first 12
hours after birth and peaked by 72 hours, by 120 hours after birth
the NAS signs were fewer than those seen at 12 hours after birth.
Of importance, the investigators report that none of the infants
required pharmacological treatment for withdrawal. Two other measures
of neurobehavioral integrity, the NICU (neonatal intensive care
unit) Network Neurobehavioral Scale (NNNS) and the Infant Acoustic
Cry were analyzed and both were found to be within normal range.
The authors also report that the infants presented a number of
adaptive behaviors including hand or thumb to mouth behaviors
and showed no signs of heightened arousal.
It is noted that this first prospective, pilot study of buprenorphine
for the treatment of opioid dependent pregnant women has a number
of limitations including small sample size, open label design
lack of controls and the fact that two of three women were in
residential care throughout their pregnancy. They indicate that
findings from more appropriate controlled studies will be necessary
to determine the generalization of the initial observations.
The Maternal Substance Abuse and Child Development Project is funded in part by the Georgia Department of Human Resources Division of Public Health.
The Maternal Substance Abuse and Child Development
Study is under the direction of Claire D. Coles Ph.D., with the
Department of Psychiatry and Behavioral Science, Emory University
School of Medicine. For more information, please contact: Claire
D. Coles: email@example.com
Karen K. Howell: firstname.lastname@example.org