Colleen Lopez
UCMNetID: Clopez92
Professor Lee
Writing 10 Section 07
15 December 2014
Addiction for Two
Abstract
The usage of maintenance therapies drug treatments such as buprenorphine and
methadone are becoming increasingly common in pregnant women as a method to help cease the
abuse of illicit drugs. After numerous findings, both maintenance therapies have been shown to
cause several side effects to the neonates that were exposed to the treatments while in the womb.
With this in mind, the main focus of this particular inquiry takes aims at investigating which of
the two maintenance treatments is the optimal choice in regards to fetal and neonatal side effects
and outcomes expressed after birth.
(Key)words to Know

Neonate: A newborn typically 28 days old or younger

Neonatal Abstinence Syndrome (NAS): Symptoms, equivalent to that of drug withdrawal
in adults, that neonates usually experience following birth and illicit drug exposure in the
womb
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
Sudden Infant Death Syndrome (SIDS): An unexplained death of a baby that is typically
healthy. SIDS usually occurs in infants that are 1 month to 1 year old.

Buprenorphine (BMT): A maintenance therapy drug that has been used to wing nonpregnant drug abusers off of illicit drug use since the 1990’s. This specific treatment has
not been approved by the FDA for use in pregnant women.

Methadone (MMT): A maintenance therapy drug that has been used since the 1970’s to
taper individuals off of substance abuse. It is the only maintenance therapy drug
recommended for use in pregnant women.
Background
Drug abuse is becoming an increasingly exacerbated problem throughout the world. As
the problem continues to worsens, the amount of women, many of whom in their childbearing
years, will ultimately become addicted to drug substances. In many of these cases, women who
are pregnant do not experience their drug abuse alone. Fetuses can ultimately absorb the
substance taken in by the mother via the umbilical cord and placenta, which could ultimately
cause addiction to occur in fetuses after continuous and extraneous use much like it would in a
fully developed adult. Despite the fetus becoming addicted to the mother’s substance abuse,
there are numerous other health consequences that arise from a mother’s constant use of
substances while pregnant which include: low birth weight, longer hospital stays, premature
delivery, poor nutritional status, developmental delays, and increased risk of both SIDS and
NAS. In the many cases, the addiction follows the baby after birth and then ultimately wreaks
havoc on the baby’s comfort and health through the side effects brought on from withdrawal
symptoms, otherwise known as Neonatal Abstinence Syndrome (NAS) which affects nearly half
of newborns born to opioid-dependent mothers (Unger, Metz, &Fischer,2012).
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In order to avoid such negative occurrences from befalling neonates and to slowly taper
off the maternal parent’s drug abuse, expecting mothers undergo maintenance drug therapies
which occur with the use of either methadone or buprenorphine. Methadone has been used as a
maintenance therapy drug for substance abuse treatment since the 1970s and has been the
recommended treatment for illicit drug abuse for some time. Its counterpart, buprenorphine, has
been utilized for a short amount of time and has only been approved for use in the non-pregnant
population since the 1990s. Despite several decades of public use of both treatments, research is
still being conducted in order to fully understand the consequences that arise in the babies that
are exposed to them in utero. Both treatments have been known to cease or hinder the NAS and
other substance abuse symptoms that arise in premature birth or in the neonates after birth,
however, there have been noted instances where both BMT and MMT have caused repercussions
of various severities of their own. The treatments themselves have been known to cause NAS of
fluctuating severity in neonates who were exposed to maternal drug use and maintenance therapy
in utero. Despite this particular NAS result, there have also been cases where both treatments
have caused numerous other side effects as well. Because little is known about both treatments, it
is in fact probable that the treatments of buprenorphine or methadone therapies were in fact not
in the best interest of the babies’ health, as much it would have been if the side effects of both
therapies had been fully understood and detected. This particular paper revolves around three
main objectives, one of which involves reviewing and examining numerous studies in order to
determine the effects that both maintenance therapies have on newborn babies. After determining
how both treatments affect babies, the focus will then shift to address which of the two therapies
is the superior, or optimal, choice in regards to fetus and neonate health based off of the results
uncovered during the first half of the paper. The lastly emphasis of the study will focus on
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whether the treatments expose fetuses and neonates to possible pain and discomfort and health
risks because many researchers are still trying to uncover all the potential benefits and side
effects of both treatments.
As previously mentioned, maternal drug use during pregnancy does in fact negatively
affect and influence the health of fetuses in utero and neonates after birth by means of
developmental delays, heart attacks, seizures, respiratory failures, strokes, birth defects,
premature birth, low birth weight, behavioral problems, and other severe effects such as still
birth. In order to cease or, at least, curb the symptoms that arise from illicit drug use, in which
mother and baby both simultaneously experience, physicians prescribe either methadone or
buprenorphine maintenance therapies to expecting mothers. In essence, both BMT and MMT can
be expensive, however, with the Affordable Healthcare Act, both treatments in extent will be
covered within many health insurance plans. This would increase the treatment opportunities for
pregnant women addicted to illicit substances as the burden of paying for the treatments are
lifted off their shoulders. It is estimated that the average methadone costs is $203.36 per month
without insurance whereas buprenorphine costs an estimated $500 per month without health
insurance and with the health insurance act, more pregnant substance addicted women will have
the opportunity to seek treatment that could potentially be beneficial to both her and her
child(ren).
Results
There have been numerous studies that have made it a main focus to determine which of
the two maintenance treatments displayed worse consequences and drawbacks when compared
to the counter treatment. Findings regarding this specific inquiry have definitely and greatly
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varied between each study. Numerous side effects have been documented for both maintenance
therapies throughout various studies. Most inquiries have suggested that both buprenorphine and
methadone therapies have similar effects regarding birth weight and height measurements
(Lacroix et al, 2011). Both outcomes tend to be benefitting because both treatments ultimately
hinder negative consequences such as low birth weight (birth weight that is classified as being
less than 2500 grams and premature birth is defined as a baby born before 37 weeks of gestation)
which could ultimately affect the overall health and wellbeing of the neonate (Buckley, Razaghi,
& Haber, 2013; Lacroix et al, 2011).
In regards to malformation and deformities, there were virtually no differences between
the two sets of participants exposed to both therapy drugs (Lacroix et al, 2011). Babies exposed
to methadone in the womb, however, were more likely to suffer withdrawal symptoms, otherwise
known as NAS, after birth. In one particular study, 62.5% of neonates experienced NAS after
methadone exposure than compared to that of 41.2% of babies that experienced NAS after
buprenorphine exposure. Those that experienced NAS after MMT exposure also tended to
experience a much more severer form of the withdrawal symptoms than compared to newborns
that experienced the symptoms after BMT exposure. In these cases, BMT exposure yielded less
serve systems yet NAS systems still occurred (Lacroix et al, 2011; Kaltenbach et al, 2012).
Possible Buprenorphine Side Effects
Babies who have also experienced NAS with buprenorphine exposure required
significantly less amounts of morphine in order to dulcify the irritability and suffering that comes
along with substance withdrawal. Current studies have shown that buprenorphine might actually
have several repercussions beyond the neonate stage of life and into the childhood stage. These
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problems could include difficulties with hand and eye coordination, visual-spatial ability,
organization, and planning capabilities (Sundelin-Wahlsten, & Sarman, 2013). Researchers have
also noted that babies exposed to buprenorphine tended to have an overall larger head
circumference when compared to methadone exposed babies (Welle-Strand et al, 2012). In one
unfortunate study, two infants died as a result from SIDS. Researchers are uncertain whether
BMT had any specific correlation with the deaths of the babies, however, they were also
uncertain if BMT could be the igniter that led to other factors that could have caused the two
infant deaths (Kahila, Saisto, Kivitie-Kallio, Haukkamma, & Halmesmӓki, 2007).
Buprenorphine maintenance treatment has not been approved for use in expectant and
breastfeeding mothers by the FDA. Currently, the FDA classifies buprenorphine maintenance
therapy as a “Category C” drug therapy, which implies that there is little to no well-controlled
studies that have been tested in the human population. A category C classification also means
that there are potential risks that arise from this specific drug treatment and or cause side effects
that can be worse than the maternal drug use that treatment therapy is meant to cease. With this
at hand, little is in place in regards to a legislative manner when it comes to the use of
buprenorphine maintenance therapy besides the fact that it currently not FDA approved which
means mothers are exposing their babies to the treatment at their own risk. In the absence of
sufficient data, the use of buprenorphine will likely not be approved by the FDA. Because of
such circumstances, the use of buprenorphine therapy treatment is solely at the physician and
patients’ risks and in such cases, the prescribing physician must weigh the consequences of BMT
treatment to the cons that arise from continued drug use. Despite lack of approval, there have
been several contrary effects on pregnancy after continuous drug use. With this in mind and with
encouragement from buprenorphine clinical guidelines, physicians must take care and caution
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when prescribing buprenorphine to pregnant women, however, neonates still face the chance of
suffering from the side effects of the treatment after birth. In other words, the attending physician
would potentially have to decide if the buprenorphine maintenance treatment poses too great a
risk to the expecting mother and the unborn fetus all the while keeping the interest of the baby
and mother’s health after birth occurs. If in fact doctors think BMT is not worth the risk, it
would then be determined if the expectant mother should slowly curb the illicit drug use or be
prescribed to methadone maintenance therapy treatment instead of being treated with a BMT
treatment.
Possible Methadone Side Effects
Babies who do become dependent on methadone while in the womb might not experience
NAS symptoms up until four weeks of birth because MMT can be stored in the metabolism for a
prolonged amount of time (Caviston, 1987), however, when withdrawal occurs then babies can
develop a wide array of symptoms. Besides the possible side effects from BMT treatments, there
have been findings that have also suggested possible correlations between fetus exposure to
methadone therapy and possible health related consequences to neonate and childhood
development. Infants who were exposed to MMT tended to face more severe symptoms of
distress such as: constant crying, irritability, hypertonic, poor reaction to visual stimuli, and less
motor maturity than compared to those exposed to buprenorphine (Johnson, Jones, & Fischer,
2003; Soyka, 2013). Other effects include longer hospital stays and NAS treatment than
compared to buprenorphine treatment counterpart drug treatment (Fischer et al, 2006).
Methadone has also been noted to correlate with more occurrences of suppression of the motor
activity (Jansson et al, 2010).
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Potential Alternative
In most cases, morphine will also be utilized along with a maintenance therapy to
alleviate some of the symptoms that arise after birth. For example, MMT might be utilized to
hinder the effects of the mother’s drug use, however, after birth a neonate might still experience
NAS symptoms. This is where morphine comes into the equation. At this point, morphine can be
used to mask the pain and discomfort that the neonate experiences following NAS symptoms.
Mothers could also have the possibility of skipping the maintenance therapy entirely and
utilizing morphine for the after effects that could occur after birth. However, there is still the
possibility that mother’s substance abuse would still be able to induce negative effects. If in fact
mothers choose this specific path, morphine might not also be the optimal route to take because
it could ultimately cause negative correlations to the neural cells of the growing brains in the
fetus or neonate (Unger, Metz, & Fischer, 2012).
◘◘
Regardless of the several repercussions that have been documented with buprenorphine
maintenance use, many researchers have deemed buprenorphine safe enough to be used as a
methadone maintenance treatment substitute; whereas some go as far to state that BMT displays
equal side effects and benefits when compared to MMT therapy and use (Lacroix et al, 2011;
Johnson, Jones, & Fischer, 2003). In fact the buprenorphine clinical guidelines state that BMT is
sufficient enough to use in the pregnant population as long as a prescribing physician highly
weighs the side effects that buprenorphine could cause to occur in a pregnant woman as the
treatment slowly tapers off of illicit drug abuse. Despite semi-approval from the buprenorphine
clinical guidelines, the FDA has yet to approve its use in expectant mothers and have so far
ADDICTION FOR TWO (CLOPEZ92) 9
recommended only methadone maintenance therapy for expecting mothers (Johnson, Jones, &
Fischer, 2003). After many other studies, there has also been many who have disapproved of the
use of buprenorphine for fear that the side effects will greatly impact the neonates’ health
(Sundelin Wahlsten & Sarman, 2013). In simple terms the results uncovered by researchers are
not conclusive and in fact greatly vary from each other much to an extent that some results
contradict or display opposite conclusions that others have come upon.
Implications and Solutions
Results regarding the benefits and side effects of both treatments are at odds as report
findings tend to vary. This, however, may be the result of researcher bias as certain scholarly
articles highly favor methadone treatment, whereas other articles favor the use of buprenorphine.
This bias unfortunately can also influence the validity of the results from the numerous studies
conducted on both the benefits and side effects of both buprenorphine and methadone treatments.
However, there are not enough studies that have been conducted to ensure the validity of any of
the results that researchers have since come across in past studies. This could as well explain the
potential researcher bias that inhibits data and findings of the studies. In essence, several factors
might be benefitting and significant when it comes to potential advancement and understanding
of both of the maintenance therapy treatments used to impede withdrawal symptoms in fetuses
and neonates. One factor includes further investigation and studies. As referenced, the findings in
studies have greatly varied since the beginning of the overall investigation of both treatments’
side effects. In order to validate a specific perspective of current findings, more research needs to
be conducted with more participants as results might face researcher bias which could ultimately
hinder the results currently seen throughput the data collected.
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Another implication that could help influence the decisions and ultimately the FDA’s
approval or disapproval of buprenorphine therapy would revolve around studies in which the
number of individuals per maintenance group is equally established between the two study
groups. Numerous cases have overlooked this potential factor that could ultimately affect the
FDA’s decision to recommend buprenorphine use in pregnant women. In one particular case, a
study focused on a total of 135 pregnant women. Of the total women being observed during the
study, 90 women had undergone buprenorphine therapy while the remaining 45 women of the
study had participated in methadone maintenance therapy (Lacroix et al 2011). Although the sole
focus of the Lacroix et al study was not to observe the effects the treatments had on the mothers
but rather the neonates, this lack of a balanced portion of treatment recipients could alter or
misrepresent the data being gathered throughout the study and thus affect the overall conclusions
that can be drawn upon by others. With much more balance between the two treatment groups,
the FDA will find it better to analyze the results seen from dozens of studies and either approve
or reject the use of buprenorphine treatment in expecting mothers who ultimately need medical
assistance to ward off substance abuse and the withdrawal effects that accompany the cessation
of addiction. Regardless of the FDA’s ultimate decision regarding the future recommendation of
BMT, it is significantly important for a balance of the control groups because physicians would
be able to prescribe the therapy to expectant mothers without knowing all the effects of the
treatments. This could potentially cause future suffering and health risks to the fetuses in the
wombs and the neonates after birth. In essence, it is essential to uncover the risks that are posed
to the babies that are exposed to such treatments and in order to do this, research needs to be
conducted in a much more balanced and controlled manner.
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Studies conducted on the focus on the benefits and side effects of BMT only and not
comparing the two treatments to each other are highly required for further understanding of BMT
treatment. Most studies aim at comparing the pros and cons of BMT to those of MMT, however,
these comparison results are not the only essential data needed. Focusing solely on
buprenorphine will allow researchers to uncover both the benefits and repercussions that arise
from use of the treatment. In some respects, the studies that compare the two treatments together
might house some sense of bias as the researchers might be intent about finding any slight
difference between the two treatments. This could potentially explain why findings and
conclusions constantly vary between different studies. If researchers instead turn away from the
mindset of trying to uncover differences between the two treatments, then perhaps they could
focus their studies on solely the aliments that arise in either buprenorphine or methadone
exposure and thus further the understanding of the effects that both treatments might have on the
newborn recipients.
Besides focusing on a specific treatment, researchers could also cut back on the variables
within their studies. There have been numerous studies that had too many variables. Some
studies focused on the effects of both BMT and MMT all the while observing women whom
were all addicted to different drugs. Instead of observing the effects in many drug addictions,
researchers should instead focus on one particular drug per study. For example, researchers could
focus on the effect that BMT has on mothers who were addicted to, say, heroin. Narrowing down
the focus of the study and eliminating several variables might enable researchers to find much
more conclusive evidence. If this approach is taken, researchers might find that BMT provides
better outcomes to neonates whose mothers were addicted to heroin rather than neonates exposed
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to MMT in the same circumstances which would thus explain why the conclusions greatly
varied.
Conclusion
Many of studies tend to come to varying conclusions about the safety of exposing fetuses
and neonates to buprenorphine therapy. Numerous conclusions tend to view buprenorphine
therapy as a risk to the neonate population (Sundelin Wahlsten & Sarman, 2013). On the other
hand, others have declared that based upon their studies and several other findings that BMT is a
safe treatment that have occasionally provided similar results and side effects when compared to
that of methadone therapy if BMT was given in appropriate dosages (Lacroix et al, 2011; Soyka,
2013). Other findings tend to suggest that buprenorphine is, in fact, the superior treatment when
compared to MMT because it has displayed several instances where outcomes have been much
more favorable in regards to neonatal growth parameters and withdrawal symptoms experienced
when compared to the counter MMT treatment (Welle-Strand et al, 2012; Kahila, Saisto, KivitieKallio, Haukkamma, & Halmesmӓki, 2007). Regardless of the standing of superiority of BMT,
some researchers suggest that the expectant mothers should have more of a say regarding which
maintenance therapy would be benefiting to both her and the baby’s preferences and life
circumstances (Jones et al, 2012). Nevertheless, the evidence displayed in all studies and the
varying conclusions that all studies have drawn to signifies that there is a need for more wellcontrolled and well-designed study cases in order to come to better conclusive understandings of
buprenorphine maintenance therapy’s effects and benefits in the fetus and neonate populations
(Johnson, Jones, & Fischer, 2003). Despite uncertainty with regards to the efficiency and level of
safeness to the health of neonates exposed to buprenorphine, more efficient research needs to be
completed in order to fully understand the pros and cons of not only BMT, but MMT as well.
ADDICTION FOR TWO (CLOPEZ92) 13
One might suggest that there is not any urgency with this specific matter and that physicians
could simply switch one maintenance therapy to the other if the desired outcomes are not being
displayed or risks are becoming too prevalent in a patient and her child. However, studies have
shown that switching therapies midway throughout the treatment could be extremely detrimental
to the fetus.
Based on the evidence at hand, I strongly believe that I am not qualified to make
judgment regarding use or superiority of either maintenance therapy treatment. I strongly believe
that in order to gain a response from the FDA regarding BMT, there needs to be more definite
conclusions because the wellbeing of both substance addicted expecting mothers and their
children could rely strongly on either MMT or BMT for quitting addiction. In essence, mothers
and babies in this specific situation face a double edged sword which includes either facing
addiction head on or the curbing of addiction with a treatment that might ultimately cause serious
side effects of its own.
My Opinion:
At the beginning of my research, I believed that both maintenance treatments were the
ideal treatments for mothers and babies addicted to illicit drugs, however, as I continued with my
research I quickly realized that little was known about the benefits and side effects that both
treatments could have on the fetuses and babies exposed to such treatments in the womb. In most
cases, doctors must simply weigh the benefits and cons of the treatment to that of the potential
outcomes the baby might experience if the treatments are not administered. In most respects to
me, I believe that this could be potentially dangerous to the baby’s health if the proposed
circumstances do not pan out exactly as the prescribing physician had thought. My overall
ADDICTION FOR TWO (CLOPEZ92) 14
opinion towards both treatments have since changed following my research and I believe that
both treatments have the potential to safely and effectively treat addiction in both mother and
child if more is known about the effects that both could have on both treatment recipients
because in essence, babies along with their mothers are fully capable, and do in most cases,
experience drug withdrawal and discomfort, health repercussions, and in some unfortunate cases,
death from drug abuse which is why this particular area of research and study is significantly
important. In regards to the treatments themselves, the guess and check manner in which doctors
prescribe the treatments might raise concerns in an ethical manner because the treatments could
also cause serve side effects to the newborns as well and until the extent of the side effects are
known, the treatments should not be fully utilized in pregnant women because in some cases, the
treatments can end up causing the similar side effects that they are ultimately intended to stop.
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