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Center for Substance Abuse Treatment. Medication-Assisted Treatment for Opioid Addiction in Opioid Treatment Programs. Rockville (MD): Substance Abuse and Mental Health Services Administration (US); 2005. (Treatment Improvement Protocol (TIP) Series, No. 43.)

  • This publication is provided for historical reference only and the information may be out of date.

This publication is provided for historical reference only and the information may be out of date.

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Medication-Assisted Treatment for Opioid Addiction in Opioid Treatment Programs.

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Chapter 13. Medication-Assisted Treatment for Opioid Addiction During Pregnancy

In This Chapter …

Acceptance of Methadone Maintenance as the Standard of Care

Diagnosing Opioid Addiction in Pregnant Patients

Medical and Obstetrical Concerns and Complications

Methadone Dosage and Management

Postpartum Treatment of Mothers in MAT

Breast-Feeding

Effects on Neonatal Outcome

Use of Buprenorphine During Pregnancy

Importance of Integrated, Comprehensive Services

Nutrition Assessment, Counseling, and Assistance

Little information exists on the prevalence of opioid use by pregnant women, but there is some information about opioid use by pregnant women entering substance abuse treatment programs. Of the 400,000 women admitted to programs in 1999, 4 percent were pregnant when admitted. Opioids were the primary substance of abuse for 19 percent of both pregnant and nonpregnant women who entered these programs (Office of Applied Studies 2002).

Acceptance of Methadone Maintenance as the Standard of Care

Methadone has been accepted since the late 1970s to treat opioid addiction during pregnancy (Kaltenbach et al. 1998; Kandall et al. 1999). In 1998, a National Institutes of Health consensus panel recommended methadone maintenance as the standard of care for pregnant women with opioid addiction (National Institutes of Health Consensus Development Panel 1998). Effective medical maintenance treatment with methadone has the same benefits for pregnant patients as for patients in general. In addition, methadone substantially reduces fluctuations in maternal serum opioid levels, so it protects a fetus from repeated withdrawal episodes (Kaltenbach et al. 1998). Comprehensive methadone maintenance treatment that includes prenatal care reduces the risk of obstetrical and fetal complications, in utero growth retardation, and neonatal morbidity and mortality (Finnegan 1991).

Methadone and buprenorphine are classified as category C drugs by the U.S. Food and Drug Administration (FDA) (i.e., lacking adequate, well-controlled studies in pregnant women). Even though buprenorphine is a category C drug, studies have also found it safe and effective when used in pregnant women (e.g., Fischer et al. 2000; Lacroix et al. 2004). Buprenorphine may be used with pregnant patients in the United States under certain circumstances (see “Use of Buprenorphine During Pregnancy” later in this chapter).

Diagnosing Opioid Addiction in Pregnant Patients

In the consensus panel's experience, some women who are opioid addicted do not acknowledge pregnancy readily, or they misinterpret early signs of pregnancy, for example, fatigue, headaches, nausea and vomiting, and cramps, as opioid withdrawal symptoms. Consequently, onset of pregnancy may cause these patients to increase their use of illicit opioids or other substances that do not alleviate their perceived withdrawal symptoms but expose their fetuses to increased serum levels of these substances.

Many women who are opioid addicted confuse the amenorrhea caused by their stressful, unhealthful lifestyles with infertility. They might have been sexually active for years without using contraceptives and becoming pregnant. The consensus panel has noted that, because methadone normalizes endocrine functions, it is not unusual for women in the early phases of MAT to become pregnant unintentionally, especially if they receive no counseling for this possibility.

Procedures for diagnosing opioid and other addictions in pregnant women should incorporate information from their medical and substance use histories, physical examinations, drug test reports, and observed signs or symptoms of withdrawal. Other indications of addiction may include evidence of diseases associated with drug use (e.g., hepatitis, bacterial endocarditis, cellulitis), poor attendance for prenatal care, and unexplained fetal growth abnormalities (e.g., intrauterine growth retardation). Using an opioid antagonist to diagnose addiction in pregnant women is absolutely contraindicated (Finnegan 1991); inducing even mild withdrawal can cause premature labor or other adverse fetal effects.

Medical and Obstetrical Concerns and Complications

Pregnant women who abuse substances, including alcohol and nicotine, have a greater-than-normal risk of medical complications. These women should be monitored regularly for signs of anemia, poor nutrition, increased blood pressure, hyperglycemia, sexually transmitted diseases (STDs), hepatitis, preeclampsia, and other complications of pregnancy or health problems related to addiction. Good nutrition, including vitamin supplements, should be encouraged. Pregnant women should be educated about the potential adverse effects of substance use on their fetuses, such as fetal alcohol syndrome and premature labor associated with opioid withdrawal or stimulant use. Patient use of prescribed medications other than methadone should be monitored for compliance with usage directions and for adverse effects.

Chronic substance use in pregnancy can cause medical complications (some are listed in Exhibit 13-1), depending on how substances are administered and when or whether problems are identified and treated. Infections account for a high percentage of these complications in pregnant women who are opioid addicted, as they do in all people who abuse opioids (see chapter 10). Infections can be profoundly harmful to both women and their fetuses, particularly if infections remain unrecognized and untreated during gestation. Hepatitis B and C, bacterial endocarditis, septicemia, tetanus, cellulitis, and STDs are especially frequent (Finnegan 1991).

Exhibit 13-1. Common Medical Complications Among Pregnant Women Who Are Opioid Addicted

Anemia
Bacteremia/septicemia
Cardiac disease, especially endocarditis
Cellulitis
Depression and other mental disorders
Edema
Gestational diabetes
Hepatitis (acute and chronic)
Hypertension/tachycardia
Phlebitis
Pneumonia
Poor dental hygiene
STDs
Chlamydia
Condyloma acuminatum
Gonorrhea
Herpes
HIV/AIDS
Syphilis
Tetanus
Tuberculosis
Urinary tract infections
Cystitis
Pyelonephritis
Urethritis

Adapted from Finnegan 1979.

The rate of vertical perinatal transmission of hepatitis B virus (HBV) is high (ranging from 70 to more than 90 percent [Centers for Disease Control 1988b ; Ranger-Rogez et al. 2002]), especially if a pregnant woman has active infection (determined by a positive hepatitis B antigen test) in the third trimester or within 5 weeks postpartum. If a new mother's hepatitis B antigen test is positive, the neonate should receive both hepatitis B vaccine and hepatitis B immune globulin (Kaltenbach et al. 1998). The rate of perinatal transmission of hepatitis C virus (HCV) is lower than that of HBV, as discussed below; however, vaccines exist for hepatitis A virus and HBV but not for HCV. Recommended laboratory tests for pregnant women who are opioid addicted are listed in Exhibit 13-2.

Exhibit 13-2. Laboratory Tests for Pregnant Women Who Are Opioid Addicted

• Complete blood count with differential and platelets
• Chemistry screen (K, Na, Cl, Ca, P, CO2, creatinine, blood glucose, blood urea nitrogen, total bilirubin, total serum protein albumin)
• Hepatic panel (liver function tests)
• Hepatitis B surface antigen (full panel if positive)
• Hepatitis C antibody
• Rubella titer
• Serology (Venereal Disease Research Laboratory or Rapid Plasma Reagin tests)
• Sickle prep (if appropriate)
• Blood type; Rh and indirect Coombs Varicella (if unsure of history)
• HIV (with counseling)
• Urine tests
Urinalysis—routine and microscopic
Urine culture and sensitivity
Urine drug screen
• Tuberculin skin test (Mantoux)
• Alpha-fetoprotein between 15 and 21 weeks' gestation (optimal, 16 to 18 weeks)
• 1-hour, 50 mg glucose challenge test at 24 to 28 weeks' gestation (at initial visit if risk factors)
• Repeat complete blood count and serology at 24 to 28 weeks' gestation
• Group B Strep vaginal-rectal culture at 35 to 37 weeks' gestation

Reprinted from Obstetrics and Gynecology Clinics of North America, 25(1), Kaltenbach et al., dependence during pregnancy. Effects and management, pp. 139–151, 1998, with permission from Elsevier.

HCV

Pregnant women with a history of injection drug use are at high risk for HCV infection and should be screened for anti-HCV antibody. HCV ribonucleic acid (RNA) testing should be performed if an anti-HCV antibody test is positive. The results facilitate referral for further evaluation, staging, and treatment of liver disease after delivery. Infants whose mothers have hepatitis C should receive HCV RNA testing along with antibody testing for HCV between ages 2 and 6 months and again between 18 and 24 months (Roberts and Yeung 2002).

During pregnancy, HCV can be transmitted vertically from mother to fetus. However, multiple studies have shown low overall HCV vertical transmission risk and greater risk from factors such as HIV co-infection or high HCV viral load (Roberts and Yeung 2002). Vaginal delivery and breast-feeding do not appear to increase the risk of neonatal HCV infection significantly (Dinsmoor 2001; Roberts and Yeung 2002). Available treatments to prevent vertical transmission, however, are limited by the fetal toxicity of the medications currently available for HCV infection.

HIV/AIDS

Pregnant women who are opioid addicted and HIV positive present a unique treatment problem. A limited number of studies with small numbers of patients have examined the relationship of HIV, methadone, and immune function (e.g., Beck et al. 2002; Siddiqui et al. 1993). These studies have not been replicated widely. Therefore, it is difficult to conclude any significant relationship involving HIV, methadone, and immune function until additional studies are completed. Studies on the combined effects of HIV antiretroviral treatment and methadone especially are needed.

During the early 1990s, before effective prevention treatments were available, studies in North America and Europe found mother-to-child or perinatal HIV transmission rates of 16 to 25 percent. However, between 1996 and 2000, after the implementation of new guidelines, studies in the United States found transmission rates of 5 to 6 percent, and more recent studies have found rates below 2 percent when antenatal antiretroviral drugs or zidovudine (AZT) is combined with cesarean section (Centers for Disease Control and Prevention 2001b ). Although AZT prophylaxis reduces the risk of perinatal HIV infection, monotherapy often is inadequate to treat a mother's HIV disease. Combination antiretroviral therapy is now the standard of care (Paul et al. 2001).

Studies in the United States and Europe have found that pregnancy has no effect on HIV progression (Burns et al. 1998; Saada et al. 2000). Studies before the availability of antiretroviral therapy showed no increase in prematurity, low birth weight, or intrauterine growth restriction associated with HIV infection. These data are difficult to interpret because of relatively high rates of adverse events in the control groups attributed to other conditions such as substance abuse (Brocklehurst and French 1998; Bucceri et al. 1997). Studies have not found increases in birth defects or fetal malformation related to HIV infection (Brocklehurst and French 1998).

The consensus panel recommends that women who are opioid addicted and HIV infected receive additional counseling and support during the postpartum period to improve their adherence to antiretroviral therapy and to meet the demands of caring for a newborn. Breast-feeding by HIV-infected women has been associated with an increased risk of HIV transmission and should be discouraged (Nduati et al. 2000).

Obstetrical Complications

Obstetrical complications in pregnant women who are opioid addicted are the same as those seen at increased rates in all women who lack prenatal care (see Exhibit 13-3). These complications may be difficult to diagnose in patients who are opioid addicted because they often deny the existence of complications or avoid medical settings. When obstetrical complications are confirmed, standard treatments, including use of medications to arrest preterm labor, can be initiated safely.

Exhibit 13-3. Common Obstetrical Complications Among Women Addicted to Opioids

Abruptio placentae
Chorioamnionitis
Intrauterine death
Intrauterine growth retardation
Intrauterine passage of meconium
Low Apgar scores
Placental insufficiency
Postpartum hemorrhage
Preeclampsia
Premature labor/delivery
Premature rupture of membranes
Septic thrombophlebitis
Spontaneous abortion

Reprinted from Obstetrics and Gynecology Clinics of North America, 25(1), Kaltenbach et al., Opioid dependence during pregnancy. Effects and management, pp. 139–151, 1998, with permission from Elsevier.

Methadone Dosage and Management

The pharmacology of methadone in pregnant women has been evaluated thoroughly. Methadone is distributed widely throughout the body after oral ingestion, with extensive nonspecific tissue binding creating reservoirs that release unchanged methadone back into the blood, contributing to methadone's long duration of action (Dole and Kreek 1973). Peak plasma levels occur between 2 and 6 hours after a maintenance dose of methadone is ingested, with less than 6 percent of the ingested dose in the total blood volume at this time. Lower sustained plasma concentrations are present during the remainder of a 24-hour period (Stine et al. 2003).

As pregnancy progresses, the same methadone dosage produces lower blood methadone levels, owing to increased fluid volume, a larger tissue reservoir for methadone, and altered opioid metabolism in both the placenta and fetus (Weaver 2003). Women who are methadone maintained often experience symptoms of withdrawal in later stages of pregnancy and require dosage increases to maintain blood levels of methadone and avoid withdrawal symptoms (Jarvis et al. 1999; Kaltenbach et al. 1998). The daily dose can be increased and administered singly or split into twice-daily doses (Kaltenbach et al. 1998).

Historically, treatment providers have based dosing decisions on the need to avoid or reduce the incidence of neonatal abstinence syndrome (NAS) (Kaltenbach et al. 1998; Kandall et al. 1999) rather than to achieve an effective therapeutic dosage. This low-dose approach, which emerged from several 1970s studies (e.g., Harper et al. 1977; Madden et al. 1977), has been contradicted by more recent studies (e.g., Brown et al. 1998; Kaltenbach and Comfort 1997). The consensus panel knows of no compelling evidence supporting reduced maternal methadone dosages to avoid NAS. On the contrary, higher dosages have been associated with increased weight gain, decreased illegal drug use, and improved compliance with prenatal care by pregnant women in MAT and with increased birth weight and head circumference, prolonged gestation, and improved growth of infants born to women in MAT (De Petrillo and Rice 1995; Hagopian et al. 1996). Moreover, reduced methadone dosages may result in continued substance use and increase risks to both expectant mothers and their fetuses (Archie 1998; Kaltenbach et al. 1998). The consensus panel recommends that methadone dosages for pregnant women be determined individually to achieve an effective therapeutic level.

Induction and Stabilization

Methadone dosages for pregnant women should be based on the same criteria as those for women who are not pregnant. Women who received methadone before pregnancy should be maintained initially at their prepregnancy dosage. However, if pregnant women have not been maintained on methadone, the consensus panel recommends that they either be inducted in an outpatient setting by standard procedures or be admitted to a hospital (for an average stay of 3 days) to evaluate their prenatal health status, document physiologic dependence, and initiate methadone maintenance if possible.

For pregnant women being inducted in an outpatient setting, a widely accepted protocol is to give initial methadone doses of 10 to 20 mg per day, with exact dosage based on a patient's opioid use history. A patient should be asked to return at the end of the day for followup evaluation, and the initial dose may be followed by regular adjustments of 5 to 10 mg based on therapeutic response (Archie 1998). Twice daily observation should continue until the patient is stabilized. If evidence of intoxication or withdrawal emerges, treatment providers should adjust the patient's dosage immediately. Most pregnant women can be stabilized within 48 to 72 hours (Kaltenbach et al. 1998). In outpatient settings, where fetal monitors usually are unavailable, it is crucial that patients record measures of fetal movement at set intervals (Jarvis and Schnoll 1995).

Split Dosing

Split-dosing methadone regimens are accepted widely for pregnant patients, but little empirical investigation has been done of its effects on fetuses or maternal plasma levels (Jarvis et al. 1999). Although split dosing may improve maternal compliance with treatment and decrease cocaine use (De Petrillo and Rice 1995), traveling to an opioid treatment program (OTP) twice a day or, for unstable or newly admitted patients, qualifying for take-home medication doses may be difficult.

Managing Polysubstance Use

A large percentage of pregnant women in MAT—up to 88 percent in one study—continue to use other substances including alcohol, nicotine, heroin, cocaine, barbiturates, and tranquilizers (Edelin et al. 1988). The risks of other substance use for both maternal and fetal health are well documented (Reid 1996). It is essential that patients be monitored for use of both licit and illicit drugs and alcohol to manage appropriately the perinatal care of both mothers and infants (Kaltenbach et al. 1998).

Polysubstance use is a special concern during pregnancy because of the adverse effects of cross-tolerance, drug interactions, and potentiation (Kaltenbach et al. 1998) and the serious maternal and fetal health risks from continued substance use and lack of adequate prenatal care (Svikis et al. 1997a ). Chapter 11 provides more information about treatment of multiple substance abuse in MAT; the forthcoming TIP Substance Abuse Treatment: Addressing the Specific Needs of Women (CSAT forthcoming f ) contains additional information on the effects of different substances on pregnant women.

Management of Acute Opioid Overdose in Pregnancy

Opioid overdose in pregnancy threatens both pregnant women and their fetuses. Naloxone, a short-acting, pure opioid antagonist, is the pharmacological treatment of choice for opioid overdose but should be given to pregnant patients only as a last resort (Weaver 2003). Patients should receive naloxone (0.01 mg/kilogram [kg] of body weight) intravenously after an airway is established to ensure adequate respiration. Patients can receive additional naloxone doses every 5 minutes after they regain consciousness. Naloxone's duration of action is from 30 minutes to 2 hours, depending on the dose and type of substance that was used, whereas that of most opioids is from 6 to 8 hours and that of methadone or other long-acting opioids (e.g., morphine sulfate contin, OxyContin®) is from 12 to 48 hours (or more for levo-alpha acetyl methadol). Therefore, symptoms are likely to recur within 30 minutes to 2 hours of naloxone treatment, and treatment providers should continue administering naloxone intravenously or intramuscularly at intervals until the effects of illicit opioids markedly diminish, which may take 2 to 3 days. Special care is needed to avoid acute opioid withdrawal that can harm a fetus. Treatment providers should titrate the naloxone dose against withdrawal symptoms and use a short-acting opioid to reverse acute withdrawal symptoms (Archie 1998).

Managing Withdrawal From Methadone

Withdrawal from methadone, called medically supervised withdrawal (MSW) or dose tapering, is not recommended for pregnant women. When MSW is considered, however, a thorough assessment is important to determine whether a woman is an appropriate candidate for MSW because the procedure frequently results in relapse to opioid use. Appropriate patients for MSW during pregnancy include those who

  • Live where methadone maintenance is unavailable
  • Have been stable in MAT and request MSW before delivery
  • Refuse to be maintained on methadone
  • Plan to undergo MSW through a structured treatment program (Archie 1998; Kaltenbach et al. 1998).

A patient who elects to withdraw from methadone should do so only under supervision by a physician experienced in perinatal addiction treatment, and the patient should receive fetal monitoring. MSW usually is conducted in the second trimester because the danger of miscarriage may increase in the first trimester and the danger of premature delivery or fetal death may increase in the third trimester (Kaltenbach et al. 1998; Ward et al. 1998a ). However, the consensus panel has found no systematic studies on whether withdrawal should be initiated only during the second trimester. If MSW is undertaken, methadone should be decreased by 1.0 to 2.5 mg per day for inpatients and by 2.5 to 10.0 mg per week for outpatients. Fetal movement should be monitored twice daily in outpatients, and stress tests should be performed at least twice a week; MSW should be discontinued if it causes fetal stress or threatens to cause preterm labor (Archie 1998; Kaltenbach et al. 1998).

Postpartum Treatment of Mothers in MAT

Current treatment practices include continuing methadone after delivery either at dosages similar to those before pregnancy or, for women who began methadone maintenance during pregnancy, at approximately half the dosages they received in the third trimester. However, no empirical data support these approaches, and any decrease should be based on signs of overmedication, withdrawal symptoms, or patient blood plasma levels (Kaltenbach et al. 1998).

Breast-Feeding

Mothers maintained on methadone can breast-feed if they are not HIV positive, are not abusing substances, and do not have a disease or infection in which breast-feeding is contraindicated (Kaltenbach et al. 1993). Hepatitis C is no longer considered a contraindication for breast-feeding.

The American Academy of Pediatrics has a longstanding recommendation (1983) that methadone is compatible with breast-feeding only if mothers receive no more than 20 mg in 24 hours. However, studies have found minimal transmission of methadone in breast milk regardless of maternal dose (Geraghty et al. 1997; Wojnar-Horton et al. 1997). McCarthy and Posey (2000) found only small amounts of methadone in breast milk of women maintained on daily doses up to 180 mg and argued that available scientific evidence does not support dosage limits of 20 mg a day for nursing women.

Effects on Neonatal Outcome

NAS

Infants prenatally exposed to opioids have a high incidence of NAS, characterized by hyperactivity of the central and autonomic nervous systems that is reflected in changes in the gastrointestinal tract and respiratory system. Infants with NAS often suck frantically on their fists or thumbs but may have extreme difficulty feeding because their sucking reflex is uncoordinated (Kaltenbach et al. 1998). Withdrawal symptoms may begin from minutes or hours after birth to 2 weeks later, but most appear within 72 hours. Preterm infants usually have milder symptoms and delayed onset. Many factors influence NAS onset, including the types of substances used by mothers, timing and dosage of methadone before delivery, characteristics of labor, type and amount of anesthesia or analgesic during labor, infant maturity and nutrition, metabolic rate of the infant's liver, and presence of intrinsic disease in infants. NAS may be mild and transient, delayed in onset or incremental in severity, or biphasic in its course, including acute neonatal withdrawal signs followed by improvement and then onset of subacute withdrawal (Kaltenbach et al. 1998). Although NAS can be more severe or prolonged with methadone than heroin because of methadone's longer half-life, with appropriate pharmacotherapy, NAS can be treated satisfactorily without any severe neonatal effects.

Onset of NAS may be delayed by other neonatal illnesses. In addition, various other conditions may mimic NAS, such as hypoglycemia, hypocalcemia, sepsis, and neurological illnesses. To rule out such conditions, infants suspected of having NAS should have a complete blood cell count with differential, electrolyte and calcium levels, comprehensive neurological consultation, and head ultrasound if indicated.

An abstinence scoring system should be used to monitor opioid-exposed newborns to assess the onset, progression, and diminution of symptoms (Kaltenbach et al. 1998). The Neonatal Abstinence Score (Finnegan and Kaltenbach 1992) is used widely to estimate NAS severity, determine whether pharmacotherapy is needed, and monitor the optimum response to therapy. All infants of mothers with an opioid use history should be scored every 4 hours. Control is achieved when the average Neonatal Abstinence Score is less than 8, infants exhibit rhythmic feeding and sleep cycles, and infants have optimal weight gains.

If pharmacological management is indicated, several methods have been found useful. The American Academy of Pediatrics Committee on Drugs policy statement on Neonatal Drug Withdrawal (1998) describes several agents for the treatment of NAS including methadone, tincture of opium, paregoric, and morphine. One method (J. Greenspan, Thomas Jefferson University Hospital, Philadelphia, personal communication, October 2006) uses neonatal opium solution (0.4 mg/mL morphine-equivalent; starting dosage, 0.4 mg/kg/day orally in six to eight divided doses [timed with the feeding schedule]). Dosage is increased by 0.04 mg/kg/dose until control is achieved or a maximum of 2.0 mg/kg/day is reached. If Neonatal Abstinence Scores stay high but daily dosage nears maximum, symptoms are reassessed and concurrent phenobarbital therapy considered. When control is achieved, the dosage is continued for 72 hours before pharmacological weaning, in which dosages are decreased 10 percent daily or as tolerated. When 0.2 mg/kg/day is reached, medication may be stopped. Decisions about dosage decrease during pharmacological weaning are based on Neonatal Abstinence Scores, weight, and physical exams.

Maternal Methadone Dosage and Extent of NAS

The relationship between maternal methadone dosage and NAS has been difficult to establish, and the consensus panel believes no compelling evidence shows that methadone reduction avoids NAS. Although a number of investigators have reported significant relationships between neonatal withdrawal and maternal methadone dosage (e.g., Malpas et al. 1995; Mayes and Carroll 1996), most have found no such relationship (e.g., Berghella et al. 2003; Brown et al. 1998).

Perinatal Outcomes

Another area of concern is the intrauterine growth of infants born to women maintained on methadone. Early research yielded somewhat inconsistent findings, and not much new has been added since the 1980s. Studies comparing infants born to women addicted to heroin but not receiving methadone with infants born to women receiving methadone found differential effects, with reduced fetal mortality and greater birth weights indicated for infants of women maintained on methadone (Connaughton et al. 1977; Kandall et al. 1977). Some studies comparing infants born to women not using opioids with infants of women in methadone treatment found lower birth weights in the latter group (Chasnoff et al. 1982; Lifschitz et al. 1983), whereas others found no differences in birth weights (Rosen and Johnson 1982; Strauss et al. 1976).

A study by Kaltenbach and Finnegan (1987) with 268 infants found that those exposed to methadone had lower birth weights and smaller head circumferences than those not exposed to drugs. However, the infants exposed to methadone were not small for their gestational age, and there was a positive correlation between head circumference and birth weight in both groups. These data suggested that infants born to women who are opioid addicted and maintained on methadone may have lower birth weights and smaller head circumferences than non-drug-exposed comparison infants, but the former are not growth restricted.

Researchers (e.g., Chasnoff et al. 1984; Jeremy and Hans 1985) who used the Brazelton Neonatal Behavioral Assessment Scale (Brazelton 1984) to investigate neurobehavioral characteristics in newborns undergoing opioid withdrawal have found differences consistently in behavior between these infants and infants born to women not opioid addicted. Infants exposed to opioids were more irritable, exhibited more tremors, and had increased muscle tone. Several studies have reported less responsiveness to visual stimuli and reduced alertness among infants exposed to opioids (Strauss et al. 1975).

Important aspects of these behavioral characteristics are their implications for mother-infant interactions. In the consensus panel's experience, these infants are frequently difficult to nurture, causing poor mother-infant bonding, which Hoegerman and colleagues (1990) suggested might be the most devastating legacy of perinatal addiction.

Developmental Sequelae

Research on developmental sequelae associated with in utero methadone exposure has found that infants through 2-year-olds function well within the normal developmental range (e.g., Kaltenbach and Finnegan 1986; Rosen and Johnson 1982). Lifschitz and associates (1985) found no significant developmental differences between children of mothers maintained on methadone and children of mothers still using heroin or using no opioids, when sociodemographic, biological, and other health factors were considered. Other data have suggested that maternal drug use is not the most important factor in how opioid-exposed infants and children develop but that family characteristics and functioning play a significant role (Johnson et al. 1987). More information is needed to update or extend these findings from the 1970s and 1980s.

Use of Buprenorphine During Pregnancy

Buprenorphine use for pregnant women has not been approved in the United States, although it may be used with pregnant patients under certain circumstances (see below). It may be a safe and effective treatment for some pregnant women who are opioid addicted, but more research is needed. Several animal studies have been conducted. However, only limited prospective and open-label studies using sublingual buprenorphine tablets in pregnant women have been reported, and these represent the most closely controlled data (e.g., Johnson et al. 2001; Lejeune et al. 2002). Several case studies have been reported, mainly in France, of buprenorphine use during pregnancy (e.g., Marquet et al. 1997, 1998). Johnson and colleagues (2003a ) provided a complete review of these reports. The studies all found that buprenorphine was well accepted by mothers and infants during the early neonatal stage and appeared useful to treat pregnant women who were opioid addicted.

In view of incomplete data and the absence of FDA approval for use of buprenorphine in pregnant patients, the consensus panel recommends that buprenorphine be used only when the prescribing physician believes that the potential benefits justify the risks. For example, patients already maintained and stable on buprenorphine who become pregnant probably should continue on buprenorphine with careful monitoring. Pregnant women who are opioid addicted but cannot tolerate methadone, those for whom program compliance has been difficult, or those who are adamant about avoiding methadone may be good candidates for buprenorphine. In such circumstances, it should be clearly documented in the patient's medical record that she has refused methadone maintenance treatment or that such services are unavailable; that she was informed of the risks of using buprenorphine, a medication that has not been thoroughly studied in pregnancy; and that she understands these risks. When treating pregnant patients, treatment providers should use buprenorphine monotherapy tablets (Subutex®) because no work has been done on the effects of fetal exposure to sublingual naloxone in buprenorphine-naloxone combination tablets (Suboxone®) during pregnancy. Consensus panelists have found that a patient already maintained on buprenorphine-naloxone combination tablets who becomes pregnant can be transferred directly to buprenorphine monotherapy tablets.

A more detailed discussion on buprenorphine use in the treatment and management of pregnant patients and its effects in newborns can be found in TIP 40, Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction (CSAT 2004a ). For a comprehensive review of buprenorphine use in pregnant patients and its effects on the neonate, see the article by Johnson and colleagues (2003a ). Current data indicate that buprenorphine probably is safe and effective for some women who are pregnant and opioid addicted, but more research is needed.

Buprenorphine Effects on NAS

Johnson and colleagues (2003a ) reviewed 21 reports of buprenorphine use during pregnancy, most from Europe, and found that NAS was reported in 62 percent of approximately 309 infants exposed to buprenorphine, with 48 percent requiring treatment and 40 percent confounded by other drug use. Another study of 100 infants of mothers maintained on buprenorphine found NAS in approximately 67 percent (Johnson et al. 2001). Of these, 53 percent required treatment for withdrawal, and approximately 7 percent were admitted to a neonatal intensive care unit. Similar to infants born to women receiving methadone, infants of women receiving comprehensive prenatal care plus buprenorphine had improved birth outcomes compared with those whose mothers received no comprehensive prenatal care.

Buprenorphine-associated NAS generally appears within 12 to 48 hours, peaks at 72 to 96 hours, and lasts 120 to 168 hours, although some reports have indicated buprenorphine-related NAS lasting 6 to 10 weeks. Buprenorphine-associated NAS was found to be less intense than that associated with methadone (Johnson et al. 2003a ). If controlled randomized trials confirm that newborns of mothers treated with buprenorphine have less NAS than those of mothers treated with methadone, it may be appropriate to switch patients from methadone to buprenorphine during early pregnancy to reduce chances for marked withdrawal syndromes in newborns.

Breast-Feeding During Buprenorphine Treatment

Research has indicated that only small amounts of buprenorphine and buprenorphine-naloxone pass into breast milk, with little or no effect on infants (Johnson et al. 2001; Schindler et al. 2003; CSAT 2004a ). These data are inconsistent with product labeling, which advises against breast-feeding in mothers treated with buprenorphine or the buprenorphine-naloxone combination. Based on research data, particularly findings that buprenorphine is likely to be poorly absorbed by infants via the oral route, the consensus panel recommends that women maintained on buprenorphine be encouraged to breast-feed because of the benefits to infants and mother-child interaction. The panel recommends more research, particularly to confirm that infants absorb little buprenorphine during breast-feeding.

Importance of Integrated, Comprehensive Services

Pregnant women who are opioid addicted need comprehensive treatment services, including individual, group, and family therapy to address both the physiological and psychological effects of substance use and psychosocial factors. Psychosocial complications may include disruption of the mother-child relationship, guilt over the adverse effects of addiction on the family, and family adjustment when a newborn is retained in the hospital. Problems associated with domestic violence, financial support, food, housing, and childcare issues can be overwhelming to women in recovery and should be addressed. AIDS prevention, counseling, testing, and educational services should be available during prenatal and parenting classes. Services should be aimed at eliminating substance use, developing personal resources, improving family and interpersonal relationships, eliminating socially destructive behavior, and helping new parents cope with their environment.

Integrated services, whether on site or through linkages to other community-based agencies, encourage prospective patients to enter a treatment program and continue treatment. Services should be woman centered and directly address traumatic events. The array of services may include

  • Special groups to address problems of pregnant women who are opioid addicted
  • Available treatments for women addicted to opioids, including pharmacotherapies
  • Education and discussion groups on parenting and childcare
  • Special groups and services for children and other family members
  • Couples counseling
  • Case management and assistance in locating safe, affordable housing.

The forthcoming TIP Substance Abuse Treatment: Addressing the Specific Needs of Women (CSAT forthcoming f ) has more detailed information on the psychosocial components of women-centered treatment.

Psychosocial Barriers

Women addicted to opioids typically face financial, social, and psychological difficulties that affect their options and treatment progress. Many have histories of negative experiences with the legal system or children's protective services that may cause them to be resistant to or noncompliant with treatment. Guilt and shame coupled with low self-esteem and self-efficacy can produce behaviors difficult for some staff members to tolerate, such as lateness, missed appointments, continued illegal drug use, and demanding or provocative behaviors. For successful treatment, care should be provided in a gender-specific, nonpunitive, nonjudgmental, nurturing manner, with attention to each patient's fears and cultural beliefs (Kaltenbach et al. 1998; Ward et al. 1998a ).

Contingency Management Treatment Strategies

As discussed in chapter 8, contingency management strategies offering positive reinforcement for behavioral change have been effective in treating a range of substance use disorders. Voucher-based reinforcement therapy (VBRT) has been particularly effective in increasing abstinence from substances and strengthening behaviors such as compliance with treatment plans and participation in vocational training (Kidorf et al. 1998; Petry 2000; Silverman et al. 1996). These and other studies also have suggested that VBRT may help manage polysubstance abuse and improve retention for pregnant women in MAT.

Although few systematic studies have been done with pregnant women who are opioid addicted, available evidence has indicated that positive-contingency rewards for abstinence or treatment attendance can improve pregnancy outcomes (Chang et al. 1992; Jones et al. 2001). Contingency management incentives for this population have ranged from cash (Carroll et al. 1995; Chang et al. 1992) to vouchers exchangeable for goods and services (Jones et al. 2000, 2001; Svikis et al. 1997b ).

Carroll and colleagues (1995) compared the effectiveness of an enhanced treatment program for pregnant patients that included a contingency management component, in which clients could earn $15 weekly for three consecutive negative drug tests, with an unenhanced treatment program. The group receiving enhanced treatment had better neonatal outcomes, but the two groups did not differ in percentages of positive drug tests. The authors attributed these results primarily to more frequent prenatal care in the contingency management group. However, results of the study were limited by the small sample size (seven women in each group), the inability to discern which components contributed to improved outcomes, and use of a demanding contingency procedure that reinforced continuous abstinence (e.g., three consecutive negative drug tests) but not discrete abstinence (each negative drug test).

Many pregnant women who receive MAT discontinue treatment prematurely, with the highest dropout rates occurring on transfer from residential to outpatient treatment. A related series of controlled, randomized studies (Jones et al. 2000, 2001; Svikis et al. 1997b ) examined whether brief voucher incentives improved patient participation and decreased substance use during this transition phase. In pregnant women maintained on methadone, low-value incentives did not influence substance use (Jones et al. 2000). However, greater incentives, using an escalating reinforcement procedure, both decreased substance use and increased full-day outpatient treatment attendance (Jones et al. 2001).

Overall, these studies have suggested that contingency management using positive rewards for desired behaviors may be an important adjunct to MAT for pregnant women. It is noteworthy that interventions such as VBRT not only are compatible with MAT but address both continued substance abuse and poor program attendance.

Nutrition Assessment, Counseling, and Assistance

People with substance use disorders often are poorly nourished. Substances themselves may impair users' metabolism, interfere with nutrient availability, and affect appetite. However, other lifestyle factors associated with substance use play a significant role, including poverty, poor eating and exercise habits, lack of concern about nutrition and health, and diets restricted by physiological conditions.

Pregnancy is an opportune time to help women improve their health-related attitudes and behaviors. The consensus panel recommends that all pregnant patients in MAT receive

  • An assessment of nutritional status, eating habits, and weight
  • Education on appropriate diet and weight to meet optimal targets for the pregnancy
  • Counseling to ensure that special nutrition-related medical and psychosocial problems are addressed—with high priority given to stopping or substantially reducing cigarette, alcohol, and other substance use with known adverse effects on fetuses
  • Supplemental nutrients when nutritional needs cannot be met by diet changes
  • Information about and referral to food assistance programs.

Nutritional Education for Pregnant Patients in MAT

Most pregnant women in MAT can benefit from nutritional guidance that encourages them to have wholesome, well-balanced diets consistent with their ethnic or cultural backgrounds and financial situations. Such guidance helps them understand how diet and substance use affect the fetus, pregnancy, labor and delivery, and breast-feeding.

Some OTPs have trained nurses or other staff members who facilitate a nutrition education program. In addition, the National Center for Nutrition and Dietetics of the American Dietetic Association (800-366-1655 or www.eatright.org) refers inquirers to registered dietitians in the local area who provide individual or group counseling or program information about diet during pregnancy. Another useful resource, Pregnancy and Nutrition, a seven-page pamphlet developed by the National Women's Health Information Center (www.4women.gov/faq/preg-nutr.htm), covers recommended dietary allowances for pregnant women, diet changes and weight gain, cravings, exercise, dietary supplements, diabetes, morning sickness, and nausea.

OTPs wishing to assess patients' knowledge about nutrition might be interested in the U.S. Department of Agriculture's 22-page survey forms (www.barc.usda.gov/bhnrc/foodsurvey) to ascertain respondents' knowledge of nutrition, food composition, labeling requirements, and serving sizes, as well as eating habits and attitudes.

Food Program Assistance for Pregnant Patients in MAT

Pregnant women in MAT who are nutritionally at risk or financially needy may be eligible for supplemental food assistance. Their school-age children also might qualify for school breakfast and lunch programs, as well as summer food programs. OTP counselors should be familiar with the services and requirements of each type of program and make appropriate referrals. Facts about food stamps can be found at www.fns.usda.gov/fns. Information about the Federal Women, Infants, and Children program can be accessed at www.fns.usda.gov/wic or www.nal.usda.gov/wicworks.

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