In infants, the agent was given sublingually under the tongue and to keep it there until it is absorbed, the physicians gave the babies pacifiers to suck. "This is the only report of a sublingual drug ever used in infants," Kraft says.
Many of the mothers of the infants receive care at the Family Center, which cares for the majority of pregnant opioid-addicted women in the Philadelphia area, Dr. Kraft says. The program is directed by co-author Karol Kaltenbach, Ph.D., who is a internationally known expert in the treatment of pregnant women with addiction.
In 2008, the research team published results from their first cohort using buprenorphine in infants. In this study, they enrolled 24 infants, half randomized to buprenorphine and half to standard of care oral morphine. The investigators found that infants treated with buprenorphine had a 23-day length of treatment, compared to 38 days for those treated with morphine. Length of hospital stay in the buprenorphine group was 32 days versus 42 in infants treated with morphine.
"They say that to truly know if buprenorphine is a better treatment for these infants, it will be necessary to conduct a double-blind randomized study in which physicians do not know which treatment has been administered. We are not using buprenorphine in infants who need treatment until we conduct this final step," Dr. Kraft says. "It is important to do the study in the most rigorous way possible, to prove the benefit of the therapy. We are currently in the planning stages of such a study."
|Contact: Rick Cushman|
Thomas Jefferson University