Two drugs fight addictions during pregnancy

After five years of research, Hendrée Jones, an associate professor at Hopkins, is drawing her final conclusions about the M.O.T.H.E.R. (Maternal Opioid Treatment: Human Experimental Research) project, a randomized clinical trial examining how two drugs help pregnant women overcome opioid addictions.

Opioids include drugs like heroin, oxycodone, codeine and morphine - not exactly things to which your doctor recommends exposing a fetus. The danger of these addictions is that they can lead to babies who are born with severe withdrawal symptoms. Without treatment these symptoms can result in death.

The M.O.T.H.E.R. project is testing two drugs that may help these women. One is methadone, a drug that has been around for years. The other is called buprenorphine, which is relatively new but shows promising results for addiction recovery. Both drugs work in similar ways - they produce the same effects as an opioid, but in a more controlled way.

Basically, methadone and buprenorphine satisfy the patient's opioid craving, but for an extended amount of time. Jones explains that the prescribed, controlled intake of the medicine gives the patient more time to focus on things like getting a job instead of focusing on things like how to get more heroin.

"I can't stand the term 'replacement therapy,'" Jones said. "The medication is taking over what the heroin used to do, but in a different way."

What is especially exciting is that buprenorphine has proven to be effective not only in treating the mothers but also in treating their babies. Results have shown that the average hospital recovery stay for newborns decreased by 1.3 days when mothers took buprenorphine instead of methadone. These two drugs help mothers-to-be overcome opioid addictions and improve their babies' chance of survival.

However, the FDA has yet to approve either. The reason methadone hasn't met approval yet, according to Jones, is that no one has taken the time to put the proof together.

"We probably know more about methadone than we do about any other drug given during pregnancy, but it still doesn't have the label saying it's approved," she said, "and that's ridiculous."

For buprenorphine, the need for approval is a bit more urgent. "Because there are so many patients being put on it, we need to know more about it," Jones said."The beauty of this study is that we're looking at not one, but both the medications... and both could be approved by the FDA for pregnant women."

This approval isn't easy to get, even with five years of research supporting her proposal. Jones said that she is hesitant to assume that the drugs, which have been clearly proven to be beneficial to both the women and their babies, will receive FDA approval.

For Jones, conducting this study has helped her understand the tough life situations that led many of the study participants to drugs. Since the women come in daily to take the medications, Jones and the other researchers have gotten to know them quite well. Some of the original participants have come back to visit with their children.

"We hope that we've had a positive impact. We've had women go on and get jobs, get their GEDs. Not everyone is successful, but we highlight the ones that are," she said. "Success is possible for these women."

Jones is keeping her fingers crossed for success with the FDA too. If this project goes through, she would like to perform a similar study looking at more complex subjects. Instead of treating pregnant women who only have opioid addictions, she would like to research the effectiveness of methadone and buprenorphine on pregnant women who have both opioid addictions and alcohol addictions.

Jones wants to expand the study to include alcohol because it commonly accompanies opioid addictions. Additionally, alcohol is even more dangerous to fetuses than opioid exposure.

"A lot of people assume that if a drug is illegal, it's the worst for the baby," Jones said. "But in reality, alcohol is by far the worst for a fetus."

Though she hasn't gotten to examine alcohol and opioids together yet, Jones is willing to take project M.O.T.H.E.R one step at a time. She admits methadone and buprenorphine aren't miracle drugs, but they do help overcome almost unbreakable opioid addictions.

And, in pregnant women, they can help stop the cycle of addiction. "If you ever want to have a positive impact on the fetus, you have to help the mom," Jones said. "Instead of rejecting and stigmatizing a mom, we should help the mom so she can transmit this positivity to the baby."