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Pharmacological Treatment of Opioid Dependence during Pregnancy: Methadone and Buprenorphine

Pharmacological Treatment of Opioid Dependence during Pregnancy: Methadone and Buprenorphine. Overview Karol Kaltenbach, PhD Maternal Addiction Treatment Education and Research Thomas Jefferson University. Pharmacological Management.

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Pharmacological Treatment of Opioid Dependence during Pregnancy: Methadone and Buprenorphine

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  1. Pharmacological Treatment of Opioid Dependence during Pregnancy: Methadone and Buprenorphine Overview Karol Kaltenbach, PhD Maternal Addiction Treatment Education and Research Thomas Jefferson University

  2. Pharmacological Management • Methadone Maintenance has been recommended for opioid dependent pregnant women since the early 1970’s • 1997 NIH Consensus Panel recommended as standard of care

  3. Methadone Maintenance and Pregnancy • Effective methadone maintenance • Prevents the onset of withdrawal for 24 hours • Reduces or eliminates drug craving • Blocks the euphoric effects of other narcotics

  4. Methadone Maintenance and Pregnancy • In addition, during pregnancy methadonemaintenance • Prevents erratic maternal opioid levels and protects the fetus from repeated episodes of withdrawal • Decreases risks to fetus of infection from HIV, hepatitis and sexually transmitted disease • Reduces the incidence of obstetrical and fetal complications

  5. Issues in Methadone and Pregnancy: Historical and Contemporary • Appropriate dose during pregnancy • Severity of neonatal abstinence related to maternal dose

  6. Issues of Dose During Pregnancy • Previous FDA regulations required the lowest “effective” dose • Dose should be based on the same criteria used for non-pregnant patients • Original work by Dole and Nyswander suggests that effective dose is usually in the range of 80-120mg • Current consensus is 50-150mg, with blood plasma levels ≥ 200ng/ml

  7. Issues of Dose During Pregnancy • In the late 1970’s recommendations emerged for pregnant women to be maintained on low dose, i.e.< 20mg • Such low dose recommendations are based on attempts to reduce or eliminate neonatal abstinence and are contrary to the therapeutic objectives of methadone maintenance

  8. Dose and Blood Plasma Levels • Subjects: N=45 pregnant women: • Six stabilized on methadone before they became pregnant. • Thirty-nine were pregnant at the time of their admit for stabilization • Age x=28yrs (19-40 yrs) • Methadone dose x=112 mg (35-215mg) • Gestational age x=26wks (10-38 wks) Drozdick et al, Am J Obstet Gynecol Vol.187, No 5, 2002

  9. Dose and Blood Plasma Levels • Results: 20 women had trough plasma levels in the therapeutic range of >200ng/ml Methadone dose x=128mg (80-190mg) Trough level x=310ng/ml Negative UDS 83%

  10. Dose and Blood Plasma Levels • Results 25 women had trough plasma levels < 200ng/ml Methadone dose x=98.6 (35-215mg) Trough plasma level x=118ng/ml Negative UDS x=40%

  11. Dose and Blood Plasma Levels • Summary of findings • The need for some pregnant women to be maintained on higher doses (>80mg) to be at a therapeutic level • The idiosyncratic variability of adequate dose • The importance of measuring methadone serum levels in making dosing decisions for pregnant women

  12. Neonatal Abstinence • Infants prenatally exposed to heroin or methadone have a high incidence of neonatal abstinence • Neonatal abstinence (NAS) may be more severe and/or prolonged with methadone than heroin • Research indicates that 60-87% of infants born to methadone maintained mothers require treatment for NAS

  13. Issues Regarding Relationship of Maternal Dose and Neonatal Abstinence • Continued debate regarding relationship between maternal dose and NAS • Often recommended to reduce maternal methadone dose to avoid neonatal abstinence • A non-therapeutic maternal dose may promote supplemental drug use and increase risk to the fetus

  14. No Relationship between NAS and Maternal Dose

  15. Methadone Dose and Neonatal Withdrawal • Mean Dose N NWT LOS <20 mg 25 3 7 20-39 mg 20 11 15 >40 mg 20 18 38 Dashe et al. Am J of Obstet Gynecol, 2002

  16. Methadone Dose and Neonatal Withdrawal Mean dose N Mean birth-weight NWT LOS <80mg 50 2769+/-559 34 (68%) 13.3 >80mg 50 2663+/-556 33 (66%) 13.6 Last dose N Mean birth-weight NWT LOS <80mg 39 2811+/-586 29 (74%) 14.2 >80mg 61 2655+/-534 38 (62%) 12.9 Berghella et al. Am J Obstet Gynecol, 2003

  17. Methadone Dose and Neonatal Withdrawal Benzo N Highest NAS NWT LOS Negative 61 10.1+/-4.4 37(61%) 9.6+/-11.5 Positive 39 13.3+/-12.8 30(77%) 19.5+/-26.3 p.08 p.09 p.01

  18. Impact of Buprenorphine • May be effective treatment alternative for some women • Women who don’t want to be maintained on methadone • Women who live in areas where methadone is not available • Women for whom methadone program compliance is difficult

  19. Buprenorphine and NAS • Buprenorphine may produce a NAS that is milder and of shorter duration than methadone. • However, need to insure that history is not repeated and that pharmacotherapy decisions are based on therapeutic objectives of treatment. • Buprenorphine should not be the treatment of choice solely on the basis of reducing symptoms of NAS.

  20. Methadone and Buprenorphine • Will increase treatment options for women • Will increase effectiveness of treatment • IF We recognize that “one size does not fit all” And pharmacotherapy decisions are based on “effective treatment”

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