Treating Pregnant and Parenting Women for Substance Use Disorders: Behavioral and Medication Strategies



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Research on the neonatal consequences of prenatal exposure to buprenorphine is quite limited.

  • Research on the neonatal consequences of prenatal exposure to buprenorphine is quite limited.
  • Not enough births have been followed for a sufficient period of time to collect convincing data regarding factors such as cognitive and social development.
  • Same issue of confounding parental and family factors in teasing apart developmental effect.
  • Reviews in Jones et al., Drugs, 2012, and Addiction, 2012

MOTHER: Sites

  • Lead Site Johns Hopkins U PI: H. Jones
  • Brown U PI: B. Lester
  • Thomas Jefferson U PI: K. Kaltenbach
  • U Vermont PI: S. Heil
  • U Vienna PI: G. Fischer
  • U Toronto PI: P. Selby
  • Vanderbilt U PI: P. Martin
  • Wayne State U PI: S. Stine
  • Coordinating Center PI: A. Arria

Compared with methadone-exposed neonates, buprenorphine-exposed neonates

  • Compared with methadone-exposed neonates, buprenorphine-exposed neonates
    • Required 89% less morphine to treat NAS
    • Spent 43% less time in the hospital
    • Spent 58% less time in the hospital being medicated for NAS
  • Both medications in the context of comprehensive care produced similar maternal treatment and delivery outcomes
  • Notes: Significant results are encircled. Site was a blocking factor in all analyses. The O’Brien-Fleming α spending function resulted in α = .0091 for the inferential tests of the Medication Condition effect for the 5 primary outcome measures at the conclusion of the trial.
  • Jones et al., N Engl J Med. 2010
  • p = .00012
  • p = .00000012
  • Buprenorphine
  • Methadone

Clinically meaningful attrition rate in buprenorphine condition

  • Clinically meaningful attrition rate in buprenorphine condition
  • Low rates of illicit drug use during pregnancy and at delivery
  • Maternal outcomes similar in the 2 study conditions
  • Note: Bonferroni’s principle was used to set familywise α = .003125 (nominal α = .05/16) for the secondary outcome measures.
  • Methadone
  • Buprenorphine
  • Jones et al., N Engl J Med. 2010
  • Relationship between Methadone Dose and 9 Clinical Neonatal Outcomes (N=73)
  • Mean (SD)
  • p
  • Total amount of morphine for NAS (mg)
  • 1.7 (3.0)
  •  
  • 1.01
  • .09
  • Duration of treatment for NAS (days)
  • 12.3 (17.2)
  •  
  • 1.01
  • .051
  • Duration of neonatal hospital stay (days)
  • 18.3 (17.2)
  •  
  • 1.00
  • .14
  • Gestational age at delivery (weeks)
  • 38.0 (2.3)
  •  
  • 1.00
  • .84
  • Apgar score at 5 minutes
  • 8.9 (1.0)
  •  
  • 1.00
  • .86
  • 12.8 (5.5)
  • .04
  •  
  • .07
  • Neonatal head circumference (cm)
  • 33.0 (2.1)
  • .00
  •  
  • .80
  • Neonatal weight (gm)
  • 2880.0 (546.2)
  • 1.55
  •  
  • .47
  • Neonatal length (cm)
  • 47.8 (4.)
  • .01
  •  
  • .57
  • Methadone and Buprenorphine: NAS
  • Jones et al., Neurotoxicol Teratol, 2013
  • Relationship between Buprenorphine Dose and 9 Clinical Neonatal Outcomes (N=58)
  • Outcome Variable
  • Mean (SD)
  • Regression Coefficient
  • Adjusted Odds Ratio
  • p
  • Total amount of morphine for NAS (mg)
  • 1.7 (3.0)
  •  
  • .98
  • .70
  • Duration of treatment for NAS (days)
  • 4.6 (6.2)
  •  
  • .99
  • .78
  • Duration of neonatal hospital stay (days)
  • 10.1 (7.0)
  •  
  • .99
  • .95
  • Gestational age at delivery (weeks)
  • 39.1 (2.2)
  •  
  • 1.00
  • .82
  • Apgar score at 5 minutes
  • 9.0 (1.1)
  •  
  • 1.00
  • .99
  • Peak NAS score
  • 11.0 (3.4)
  • -.05
  •  
  • .50
  • Neonatal head circumference (cm)
  • 33.8 (1.9)
  • .01
  •  
  • .78
  • Neonatal weight (gm)
  • 3096.9 (561.2)
  • 1.34
  •  
  • .91
  • Neonatal length (cm)
  • 49.8 (2.7)
  • .04
  •  
  • .48
  • Methadone and Buprenorphine: NAS
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