Boston Medical Center has long been a leader in addiction medicine, touching all aspects of care, including pregnancy. At BMC’s Project RESPECT, a high-risk obstetrical and addiction recovery program, providers care for women with opioid use disorder (OUD) during and after their pregnancy. To manage OUD, the standard of care is medication-assisted treatment (methadone or buprenorphine), which is known to be safe and effective during pregnancy. Over the last few years, Project RESPECT providers have seen a handful of women who had been on naltrexone which was then discontinued due to pregnancy. Naltrexone is an opioid receptor blocker and while it is not the first line treatment for OUD, it can be an effective tool in assisting recovery for some patients. However, guidelines for naltrexone therapy during pregnancy are unclear and most naltrexone providers do not feel comfortable prescribing it to pregnant women. Denied treatment, these women experienced dangerous and potentially unnecessary gaps in recovery care which resulted in destabilization and often, relapse.
The gap in care while pregnant is something the providers at Project RESPECT sought to prevent. It begged the question, why stop the use of naltrexone in pregnancy and disrupt a treatment option keeping these women stabilized?
A study led by Elisha Wachman, MD, neonatologist at Boston Medical Center and Kelley Saia, MD, director of Project RESPECT sets out to learn if naltrexone could be an alternative treatment during pregnancy for women who have OUD and are already stable on the medication. The main goal of this study is to acquire good, solid data on the use and safety of naltrexone during pregnancy, which includes studying how the medication affects both mothers and babies from delivery to one year after post-partum—an area that is able to be observed due in large part to BMC’s strong collaboration across departments and the continuity of care between prenatal care, delivery and pediatrics. This study will also look at pharmacokinetic data, which includes understanding blood levels of the medication during pregnancy. These levels will help determine, how much of the medication is transferred to the infant or how much of it is transferred into breast milk—key factors in determining the correct dosage of naltrexone.
Another aspect of the study is comparing women who are on naltrexone to those who are on commonly used medications such as buprenorphine. In doing so, the study will better recognize naltrexone’s impact on infant development as opposed to another OUD management medication during pregnancy. Lastly, the study will begin discovering if naltrexone use during pregnancy bears any changes to babies’ genetic risk profiles.
Naltrexone will not be appropriate for every expectant mother, but it could it be appropriate for some. This study could help women with OUD in the future by providing evidence-based medicine to safely expand treatment options.
“If you look across the country, it’s pretty limited on who is doing this and people who feel comfortable with this treatment. BMC is ahead of the curve,” Wachman states. BMC’s leadership in all aspects of addiction and recovery have made it understandably obvious as to why this study makes so much sense to live at this hospital. As other obstetric and gynecologists and physicians in the United States are still slowly embracing taking care of pregnant women with substance use disorders, BMC proves it’s at the forefront.
While the study is still in its early stages, data is showing participants are experiencing continued stabilization of their opioid use disorder through the stress of pregnancy. Saia explains, “Women are getting pressure from every angle of society about what to do and what not to do in pregnancy and being able to confidently offer them this option is powerful for them, for their own self efficacy and for their progress in recovery.” Looking ahead, both Wachman and Saia plan to continue to be diligent with their research and how it is rolled out so they can generate solid and credible data about the safety and use of naltrexone in pregnant women.
As the study continues to gain traction, the goal is to increase recruitment of women who are stable on naltrexone prior to pregnancy. This will not only create good data but will allow these women to help other women who are in the same situation as them. “It’s great to be on the cutting-edge of all of this and seeing things change over time as we learn more,” Wachman concludes.. “You know things definitely aren’t stagnant at all in this area. So we are constantly changing our care practices and it’s really exciting to be a part of it all.”
