Editor’s Note: This article was adapted from an article that ran in the Journal of Substance Abuse Treatment (JSAT), in accordance with a partnership agreement between Counselor Magazine and JSAT,  to bridge the gap between research and clinical practice in the addiction field.

Clinicians face many challenges daily in attempting to develop and implement a treatment program for a pregnant woman suffering from opioid dependence. This article uses a specific case study that is illustrative of the type of situations encountered by clinicians who are treating opioid-dependent pregnant patients, in order to answer some common questions and discuss evidence-based approaches to meeting the clinical challenges faced when managing opioid-dependence during pregnancy.

It is estimated that each year, 53,400 babies are exposed to heroin or nonmedical opioid analgesics in the womb (NIDA, 1996). Since this survey was published, the nonmedical use of analgesics has increased for pregnant women, with self-reported use increasing from 51,900 in 1993, to an average of 109,000 in 2002 to 2004 (Colliver et al., 2006).

As our case study demonstrates, dependence on illicit opioids like heroin or misused prescription opioids often begins many years before pregnancy. This opioid use disorder often continues during pregnancy and is typically closely associated with a multitude of environmental, personal and medical factors, many of which can contribute to increased morbidity in the neonate. Low birth weight, increased infection and prematurity have been associated with the aforementioned risk factors, all of which pose a risk for developmental sequelae of these children [see Kaltenbach et al. (1998) for a review]. 

Identifying the patient
How to screen pregnant women for opioid dependence. Asking open-ended questions about substance use before pregnancy may be informative, as is asking about items on a DSM criteria checklist for substance abuse or dependence. The Drug Abuse Screening Test (DAST; Skinner, 1982) is widely used to identify patients who have a problem with drugs. If opioid dependence is the problem, quantifying the presence and severity of withdrawal can be performed using the Clinical Opiate Withdrawal Scale (COWS; Wesson et al., 1999) and the Subjective Opiate Withdrawal Scale (SOWS; Bradley et al., 1987; Gossop, 1990; Handelsman et al., 1987). Given the stigma and fears associated with admitting illicit opioid use, a more objective screening method, like urine drug screening, is helpful for problem verification. The legal ramifications of screening and reporting of maternal substance use in pregnancy differs state by state, and counselors should be familiar with local laws.

In addition to drug problems, patients also have numerous pressing concerns (see Figure 1) that, if addressed, enhances a patient’s ability to initiate and continue the treatment process. The drug abuse treatment counselor may provide valuable case management and coordination of the pregnant patient’s case to ensure multiple issues are being addressed. Collaboration of addiction counseling agencies, physicians and ancillary social services ensures the patient is referred and receives prompt and effective assistance. Communi­cation among team members is vital. Program rules should be clearly communicated to patients and consistently applied. Program rules and policies should be patient-centered, empowering (not punitive), and reflect a barrier-reduction approach to treatment.

Assessing the patient
Therapeutic alliance building. Regardless of prior treatment history, it is imperative for all staff interacting with patients to convey a message of hope and optimism, and that the patient holds the potential for treatment success. Routine assessment questions should be approached in a sensitive, caring and non-judgmental manner. Asking open-ended questions in a direct and straight forward manner (e.g., “How has heroin use affected your life?”; “What specific concerns do you have today?”) may elicit factual information about drug use and the patient’s other problems. An effective interview should focus questions on the “what, who, when, where, how” and typically avoid “why” questions that patients often have difficulty answering, feel are stigmatizing and may fear that their answers will be used by providers to judge their suitability to be a parent. More candid answers and open rapport will be built using simple ­language, avoiding ‘street’ terms, and maintaining, nonjudgmental and accepting voice or body language when asking or receiving answers to more sensitive questions about sexual and/or interpersonal violence history.  Efforts should be taken to ensure that patients are not repeatedly asked for the same information by different staff and that laws regarding confidentiality and reporting of abuse are known to the patient and followed by all staff.

Individualized treatment. Each patient should receive individualized treatment based upon a comprehensive assessment. Using the case study as an example, Mary’s comprehensive assessment revealed the case vignette information influenced her individualized treatment plan (Figure 1). 
Build motivation and commitment to treatment. Often patients spend hours completing self-report questionnaires during an intake assessment; summarizing this information and providing a written synopsis to patients has proven helpful in building motivation for behavior change and commitment to treatment as well as conveying to the patient that she is understood by the treatment team (see Figure 2). This technique is employed in motivational interviewing (Miller et al., 2002). Tailoring feedback to each patient’s situation provides a simple and effective way to convey the impact of drug use on multiple life areas and help the patient explore their motivation to change. Effective feedback is given in a neutral and nonjudgmental manner. Feedback first presents positive behaviors and/or protective factors and then summarizes the areas that would benefit from improvement.  This feedback can be used to develop an agreed upon treatment plan with the patient. Revisiting the initial feedback summary can be helpful over the course of treatment to track progress toward specific personal and program goals.

Using an agonist to treat opioid-dependence during pregnancy
Opioid-agonist treatment objectives for pregnant patients, like Mary, are similar to those of their non-pregnant counterparts. These objectives include: preventing opioid withdrawal signs/symptoms; comfortable medication induction; and blocking the rewarding effects of illicit opioids while diminishing the motivation (i.e., craving, social interactions) to use illicit opioids and other drugs of abuse. There also are the pregnancy-specific objectives of eliminating fetal exposure to illicit opioids and other drugs and stabilizing the intrauterine environment to avoid fetal exposure to episodic periods of intoxication and withdrawal as such exposures could have deleterious consequences for fetal and post-birth health.

Meeting these objectives may optimize both drug treatment retention and compliance with prenatal care. The patient and provider should discuss the benefits and disadvantages of both available agonist medications to determine which one is best for her (See Figure 1). Regardless of medication selection, comprehensive services specific to the problems associated with opioid-dependence and pregnancy are vital for initiating and sustaining substance abstinence (Finnegan, 1991). 

Methadone. Methadone is a manufactured drug that can replace some of the effects of heroin and other opioids and has the advantage that it is long acting (less to no euphoria) and can be taken orally rather than by injection. Although not approved for use by the FDA for pregnant patients, it is considered the standard of care given over 40 years of experience with treatment. Like any medication, methadone has associated risks or side effects for both mother and child. Risks for the mother are the same as for non-pregnant patients; however, the pregnancy status introduces some added complications and considerations. For example, it is often difficult to distinguish between pregnancy-related symptoms and methadone side-effects (e.g., nausea and vomiting in first and second trimester). There are known reductions in fetal heart rate and movement following methadone dosing, yet the implication of these fetal changes on long-term development are unknown. Risk of neonatal withdrawal (e.g., poor feeding, disrupted sleep, extreme irritability, etc.) following methadone exposure in the womb also is a clinical concern. Rating scales are available to assess and prescribe medication treatment regimes for withdrawal. With­drawal severe enough to require treatment does not appear to be associated with any long-term developmental consequences for the child. The benefits of methadone over continued illicit opioid use include: eliminating the need for illicit opioid use; decreasing risk of HIV risk behaviors; reducing drug seeking behaviors, such as prostitution and other criminality; protecting the fetus from repeated episodes of withdrawal; and increasing retention in treatment [see Kaltenbach et al, 1998 for review]. Thus, benefits that methadone provides within a comprehensive care setting to this patient population far outweigh its potential risks.

Buprenorphine. Although only approved for the treatment of opioid-dependence in non-pregnant individuals, buprenorphine is being prescribed frequently to opioid-dependent pregnant patients. Like methadone, buprenorphine is a manufactured medication that works to treat opioid-dependence by blocking the effects of other opioids, and is generally accepted by patients because it produces some positive psychoactive effects that helps to maintain patient adherence with medication ingestion. Buprenor­phine produces less physical dependence or respiratory depression than methadone, and abruptly stopping buprenorphine generally produces mild withdrawal. It is for these reasons that buprenorphine may be beneficial for the pregnant mother and possibly the neonate.

Buprenorphine comes in two forms (Subutex® (buprenorphine alone) and Suboxone® (buprenorphine with naloxone). Either type of tablets are taken by holding them under the tongue and produce similar clinical effects (e.g., Stoller et al., 2001). The addition of naloxone in Suboxone® helps reduce the chance that the medication will be misused by opioid-dependent individuals. Suboxone® is relatively contraindicated in pregnancy due to the unknown effects of naloxone on the developing fetus. In pregnant women, buprenorphine alone (Subutex®) is preferred.

Currently available data about the prenatal exposure to buprenorphine does not indicate that buprenorphine treatment during pregnancy is associated with greater risk to the mother or embryo/fetus than treatment with methadone (see Jones et al., 2008). How­ever, management of patients on bupre­norphine presents unique challenges and potential benefits compared to those encountered with methadone. Given the different ways the two ­medications work, methadone and buprenorphine cannot be used interchangeably and methadone-maintained patients are not always good candidates for buprenorphine.  

The maternal and neonatal risks of buprenorphine are similar to those ­mentioned for methadone. Currently, buprenorphine appears as safe as methadone for the pregnant mother and her child; however, methadone remains the standard of care due to the considerably longer period of experience in its administration in pregnant women. The benefits to the mother include those noted with methadone, as well as the additional benefit of reduced respiratory depression with increasing doses. The benefits to the child include those discussed above with methadone.

Medication selection
While medication choice is often dictated by medication availability in a geographical area, medication selection should be made by the provider in consultation with the patient based upon the patient’s individual situation. There are some clear decision points in medication selection for those patients new to opioid treatment and those patients already stabilized on an agonist medication prior to pregnancy. First, patients stabilized on methadone before pregnancy should not have their medication discontinued, as case studies associated such morbidities as stillbirth, fetal distress and premature delivery with detoxification from methadone (Blinick et al., 1969; Rementeria & Nunag, 1973; Zuspan et al., 1975). Moreover, most methadone maintained patients who become pregnant would not be candidates for transition from methadone stabilization to buprenorphine as this transfer introduces the possibility for destabilization and drug use relapse.  Second, buprenorphine should be prescribed only when specialized services for pregnant women in methadone maintenance programs are unavailable in the community or the patient has refused methadone (CSAT, 2004).  Because methadone is the recommended treatment for pregnant women, many women taking buprenorphine who become pregnant are being transferred from buprenorphine to methadone (Jones et al., in press a).

Methadone induction. Guidelines for inducing pregnant patients to methadone have been well-established (CSAT, 1993, 2005; Kaltenbach et al., 1998). 

Buprenorphine induction. Although not FDA-approved for use in pregnancy, buprenorphine is being used to treat pregnant patients when the risk: benefit ratio favors buprenorphine treatment. Subutex® is the preferred medication over Suboxone®. Using Subutex avoids prenatal exposure to an additional medication, naloxone, which has unknown potential for fetal and neonatal toxicity. 

The complex pharmacology (mu oipioid receptor partial agonist/kappa opioid receptor antagonist) of buprenorphine may make induction more challenging. Administering buprenorphine too soon after the last opioid ingested or in too high a dose, increases the potential for significant precipitated withdrawal. As with methadone, if the buprenorphine dose is too low, it may not relieve withdrawal symptoms completely, or for 24 hours until the next dose is due (e.g., Lintzeris et al., 2001). 

Our own experience has shown that rapid induction onto 12-14 mg of buprenorphine in two to three days can be accomplished in pregnant women (e.g., Jones et al., 2005a,b; Fischer et al., 2006). Ideally, doses should be based upon the severity of opioid dependence. The pharmacology of buprenorphine makes it less likely to result in sedation.

Induction issues common to both medications. Regardless of medication prescribed, patients should be cautioned to avoid both licit and illicit drugs for her health, the health of the fetus, treatment success and potential interaction of the medication that could lead to adverse reactions and overdose. The risk of overdose is especially increased when benzodiazepines are used and should be used with extreme caution if at all.  Some­times additional medications that are safe for use during pregnancy are needed to ease the common symptoms of withdrawal during induction onto either methadone or buprenorphine (Jones et al., 2008). Educating patients regarding behavioral methods to control withdrawal symptoms may minimize medication use. For example, to address Mary’s sleeping difficulty she received information concerning sleep hygiene (e.g., bedtime preparation routine, no caffeine drinks after 6 p.m.). These techniques improved her sleep and a prescribed sleep aid was unnecessary.

Psychosocial issues arising during induction. Initiating treatment can be simultaneously exciting and stressful. There are new rules and consistency in behavioral expectations with which patients are not familiar. Experienced clinicians are experts in dealing with late arrivals, requests for additional medication, premature take-home medication requests and purported emergencies that preclude daily clinic visits. Partners of the pregnant patient who are active drug users, unsupportive of treatment and/or against medication during pregnancy (as in Mary’s case) are frequent barriers to successful care. Partner education and engagement in treatment (if appropriate), can help overcome partner resistance and increase the social support of the pregnant patient.

Medication stabilization
Methadone. Methadone stabilization protocols and recommended dose adjustment guidelines are available in the CSAT TIP #43 (2005). Methadone is generally administered once daily.  How­ever, as pregnancy progresses, patients may need elevations of their dose to maintain therapeutic plasma levels and prevents relapse and break-through withdrawal signs and symptoms.  If single daily doses fail to mitigate withdrawal, split-dosing (total daily dose is given in two divided doses separated by at least eight hours) is a successful option. 

Buprenorphine. For stabilization, doses between 4 mg to 24 mg per day may be appropriate for non-pregnant patients (Chiang & Hawks, 2003); however, there is no recommended minimum or maximum dose in the buprenorphine product insert. As with methadone, the primary goal in choosing a stable dose of buprenorphine for a given patient should be to attain a level that suppresses opioid withdrawal effects, and hence, provides the best opportunity to retain the patient in treatment. Given the long biological half-life of buprenorphine and unique pharmacology it is anticipated that split dosing will generally not be necessary.

Preventing relapse. The best approach to relapse prevention is to recognize and address the patient’s warning signs before drug use occurs. The patient’s clinical presentation at each visit should be noted for any changes that suggest precursors to relapse. Careful observation and probing questions about the patient’s behavior will often reveal what behaviors need to be in place to support drug abstinence. For example, after two months of providing drug-negative urine samples, consistently participating in daily NA meetings and week-day online GED course attendance, Mary’s counselor noticed she had sporadic NA attendance and missed two of the five GED sessions in one week. 

Managing relapse. Reviewing the antecedents and consequences of illicit drug use with a functional analysis helps keep the focus on the who, what, how, when, and where of drug use and provides and opportunity to implement treatment plan changes to minimize continued drug use by the patient. In Mary’s case, she began using heroin again following a fight with her boy­friend. The counselor acknowledged the lapse in a non-judgmental manner and focused the session on helping Mary identify ways that she could prevent such an event from becoming a relapse. 

While any illicit drug use is concerning, which illicit drug a patient is using is also a key to determining areas for treatment plan revision. For example, opioid use relapse may indicate the need for a dose increase because she is metabolizing the methadone too quickly or is being exposed to cues that set the occasion for her use. If there is no evidence of withdrawal and the medication dose is ­adequate, what other factors are maintaining her behavior (e.g., self-medication to numb trauma symptoms).  For some women, pregnancy can be a time when intrusive images or feelings of past trauma emerge. Some of these thoughts and feelings may coincide with the baby moving inside her.  If non-opioids are being used, the dose of her medication may not require an adjustment, as metha­done and buprenorphine only treat opioid dependence; however, the role that opioid abstinence symptoms play in this behavior (e.g., benzodiazepines or alcohol used to self-medicate anxiety or other withdrawal symptoms) needs consideration as does the potential lethal combinations of CNS depressants. The concomitant abuse of non-opioid licit (including tobacco and alcohol) and illicit drugs is an issue to address ­clinically. 

Post-partum treatment phase
With some exceptions (e.g., medication-induced slow labor or operative delivery requiring anesthesia), patients should continue to receive their agonist medication without interruption (e.g., daily dosing) while hospitalized before and after childbirth (CSAT, 2005; Jones et al., 2006c, in press b). 

Mothers can be an important source of information about the Neonatal Abstinence Syndrome (NAS) signs of the infant, so it is important that she be ­provided with education specifically related to her own child’s NAS symptoms and treatment. Treatment of NAS is important for the infant’s health and well-being rather than a source of guilt that the mother did something “wrong” to her child during pregnancy.

Breast-feeding. Breast milk is the most complete form of nutrition for infants (e.g., USDHHS, 2000). There is little methadone in breast milk and ingesting breast milk relative to formula appears associated with less severe NAS (Abdel-Latif et al., 2005); so, breast-feeding is compatible with methadone and should be encouraged. Gradual weaning from breast-feeding is recommended, as at least two infants appeared to develop NAS following abrupt discontinuation of breast-feeding by women receiving 70 mg and 130 mg of methadone, respectively (Malpas & Darlow, 1999). Breast-feeding is not recommended in women who are HIV-positive status and/or continue using illicit drugs and/or alcohol. Hepatitis C is not a contraindication for breast-feeding. As nicotine has been found in breast-milk, cigarette smokers should be counseled about the negative effects of smoking on health and encouraged to quit. The recommendations regarding breast-feeding for mothers maintained on buprenorphine follow the same indications as with methadone (CSAT, 2005).  Mothers should also be advised that there isn’t enough methadone or buprenorphine in breast milk to treat NAS. Moreover, they should not try to give any of their own medication to the child to treat NAS. If they are concerned about withdrawal in the child they should seek medical help ­immediately.

Considering dose changes of metha­done or buprenorphine. Post-delivery, recommendations suggest that patients be maintained on methadone doses similar to levels received prior to pregnancy. If patients wish to be medication free upon delivery of the child, they should be advised of the stresses of early motherhood, the possibility of relapse during medication tapering and the benefits of agonist maintenance. Clinical recommendations suggest that postpartum methadone doses may be reduced to half the dosage required in the third trimester (CSAT, 2005).

These recommendations may depend on the amount of metha­done received during pregnancy (Jones et al., in press a). Given the large individual variability among patients, dose changes should be guided by signs and symptoms of over- or under-medication (Kaltenbach et al., 1998).

Mary’s  progress
Mary’s case illustrates current opioid and cocaine dependence. Her treatment assessment included multiple components, which helped her treatment team understand the context of her drug dependencies and enabled them to effectively plan her treatment (see Figure 1). 
Mary lives near the city methadone clinic via bus route. Given her opioid use severity profile of multiple injections daily, she and her care provider agreed that methadone maintenance was best for her.  Mary’s induction onto and maintenance on methadone was uneventful. 

Mary’s positive screen for major depression and Post-Traumatic Stress Disorder (PTSD) was followed up with assessment, evaluation, and treatment by a psychiatrist. The addiction psychiatrist and local hospital obstetrician coordinated medication regimens to treat Mary’s major depression and anemia and to manage her hepatitis C. The choice of medication for depression was such that it was safe in pregnancy and did not interfere with the metabolism of the methadone. Mary’s adherence to her multi-medication regimen was im­proved due to her counselor’s assistance with Medicaid enrollment to pay for multi-component care. Mary took an online GED class to obtain a high school equivalent degree to increase her job opportunities. Finally, Mary was introduced to a 12-month abstinent program graduate who became her “recovery sister”/ NA sponsor. With the exception of her lapse early in treatment, Mary attended 90 NA meetings in the first 100 days of treatment.

With her counselor’s consistent reminders, Mary attended 90 percent of her scheduled obstetrical appointments and delivered a baby girl, with head circumference, length, and birth weight within normal limits for the delivery at 38 weeks gestational age. Mary, fully abstinent from both heroin and cocaine for the last trimester of her pregnancy, breast-fed her baby with repeated help from the lactation consultant. Mary’s baby had some signs of withdrawal but these were not severe enough to require medication treatment. At four weeks postpartum Mary complained of feeling too sedated on her dose and it was reduced by 10 mg. In talking with Mary several weeks after the birth of her baby, she was very pleased to have a healthy baby and with the progress she made in treatment. Mary commented that “Methadone has given me my life back and enabled me to care for my child.”  

Hendree Jones, PhD is a licensed psychologist in the state of Maryland, an Associate Professor at Johns Hopkins University (JHU) School of Medicine and the Director of Research for the Center for Addiction and Pregnancy, and the Executive Program Director of Cornerstone, an aftercare program for detoxified heroin dependent patients. For more than 15 years she has been funded by NIDA as a principal investigator designing and leading studies that focus on the in utero exposure
to abused substances.

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This article is published in Counselor, The Magazine for Addiction Professionals, October 2009, v.10, n.5, pp.10-19.

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BabyBulldog2010  - Rebuilding Lives: Helping Women Recover from Opioi   |150.142.232.xxx |2011-06-24 04:10:20 Hello: I noticed that the a portion of the Clinical Vingette is missing. Please assist me with how to proceed to getting a copy of the missing portion. Thanks Linda Reply 0   0

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