Buprenorphine versus methadone in the treatment of pregnant opioid-dependent patients: Effects on the neonatal abstinence syndrome

Hendree E. Jones; Rolley E. Johnson; Donald R. Jasinski; Kevin E. O'Grady; Christian A. Chisholm; Robin E. Choo; Michael Crocetti; Robert Dudas; Cheryl Harrow; Marilyn A. Huestis; Lauren M. Jansson; Michael Lantz; Barry M. Lester; Lorraine Milio

doi:10.1016/j.drugalcdep.2004.11.013

Buprenorphine versus methadone in the treatment of pregnant opioid-dependent patients: Effects on the neonatal abstinence syndrome

Hendree E. Jones, Rolley E. Johnson, Donald R. Jasinski, Kevin E. O'Grady, Christian A. Chisholm, Robin E. Choo, Michael Crocetti, Robert Dudas, Cheryl Harrow, Marilyn A. Huestis, Lauren M. Jansson, Michael Lantz, Barry M. Lester, Lorraine Milio

School of Medicine

Research output: Contribution to journal › Article › peer-review

218 Scopus citations

Abstract

This study was designed to compare the neonatal abstinence syndrome (NAS) in neonates of methadone and buprenorphine maintained pregnant opioid-dependent women and to provide preliminary safety and efficacy data for a larger multi-center trial. This randomized, double-blind, double-dummy, flexible dosing, parallel-group controlled trial was conducted in a comprehensive drug-treatment facility that included residential and ambulatory care. Participants were opioid-dependent pregnant women and their neonates. Treatment involved daily administration of either sublingual buprenorphine or oral methadone using flexible dosing of 4-24 mg or 20-100 mg, respectively. Primary a priori outcome measures were: (1) number of neonates treated for NAS; (2) amount of opioid agonist medication used to treat NAS; (3) length of neonatal hospitalization; and (4) peak NAS score. Two of 10 (20%) buprenorphine-exposed and 5 of 11 (45.5%) methadone-exposed neonates were treated for NAS (p = .23). Total amount of opioid-agonist medication administered to treat NAS in methadone-exposed neonates was three times greater than for buprenorphine- exposed neonates (93.1 versus 23.6; p = .13). Length of hospitalization was shorter for buprenorphine-exposed than for methadone-exposed neonates (p = .021). Peak NAS total scores did not significantly differ between groups (p = .25). Results suggest that buprenorphine is not inferior to methadone on outcome measures assessing NAS and maternal and neonatal safety when administered starting in the second trimester of pregnancy.

Original language	English (US)
Pages (from-to)	1-10
Number of pages	10
Journal	Drug and alcohol dependence
Volume	79
Issue number	1
DOIs	https://doi.org/10.1016/j.drugalcdep.2004.11.013
State	Published - Jul 1 2005

Keywords

Buprenorphine
Infants
Methadone
NAS
Opioids
Prenatal
Women

ASJC Scopus subject areas

Toxicology
Pharmacology
Psychiatry and Mental health
Pharmacology (medical)

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10.1016/j.drugalcdep.2004.11.013

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Jones, H. E., Johnson, R. E., Jasinski, D. R., O'Grady, K. E., Chisholm, C. A., Choo, R. E., Crocetti, M., Dudas, R., Harrow, C., Huestis, M. A., Jansson, L. M., Lantz, M., Lester, B. M., & Milio, L. (2005). Buprenorphine versus methadone in the treatment of pregnant opioid-dependent patients: Effects on the neonatal abstinence syndrome. Drug and alcohol dependence, 79(1), 1-10. https://doi.org/10.1016/j.drugalcdep.2004.11.013

Jones, HE, Johnson, RE, Jasinski, DR, O'Grady, KE, Chisholm, CA, Choo, RE, Crocetti, M, Dudas, R, Harrow, C, Huestis, MA, Jansson, LM, Lantz, M, Lester, BM & Milio, L 2005, 'Buprenorphine versus methadone in the treatment of pregnant opioid-dependent patients: Effects on the neonatal abstinence syndrome', Drug and alcohol dependence, vol. 79, no. 1, pp. 1-10. https://doi.org/10.1016/j.drugalcdep.2004.11.013

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title = "Buprenorphine versus methadone in the treatment of pregnant opioid-dependent patients: Effects on the neonatal abstinence syndrome",

abstract = "This study was designed to compare the neonatal abstinence syndrome (NAS) in neonates of methadone and buprenorphine maintained pregnant opioid-dependent women and to provide preliminary safety and efficacy data for a larger multi-center trial. This randomized, double-blind, double-dummy, flexible dosing, parallel-group controlled trial was conducted in a comprehensive drug-treatment facility that included residential and ambulatory care. Participants were opioid-dependent pregnant women and their neonates. Treatment involved daily administration of either sublingual buprenorphine or oral methadone using flexible dosing of 4-24 mg or 20-100 mg, respectively. Primary a priori outcome measures were: (1) number of neonates treated for NAS; (2) amount of opioid agonist medication used to treat NAS; (3) length of neonatal hospitalization; and (4) peak NAS score. Two of 10 (20%) buprenorphine-exposed and 5 of 11 (45.5%) methadone-exposed neonates were treated for NAS (p = .23). Total amount of opioid-agonist medication administered to treat NAS in methadone-exposed neonates was three times greater than for buprenorphine- exposed neonates (93.1 versus 23.6; p = .13). Length of hospitalization was shorter for buprenorphine-exposed than for methadone-exposed neonates (p = .021). Peak NAS total scores did not significantly differ between groups (p = .25). Results suggest that buprenorphine is not inferior to methadone on outcome measures assessing NAS and maternal and neonatal safety when administered starting in the second trimester of pregnancy.",

keywords = "Buprenorphine, Infants, Methadone, NAS, Opioids, Prenatal, Women",

author = "Jones, {Hendree E.} and Johnson, {Rolley E.} and Jasinski, {Donald R.} and O'Grady, {Kevin E.} and Chisholm, {Christian A.} and Choo, {Robin E.} and Michael Crocetti and Robert Dudas and Cheryl Harrow and Huestis, {Marilyn A.} and Jansson, {Lauren M.} and Michael Lantz and Lester, {Barry M.} and Lorraine Milio",

note = "Funding Information: We are indebted to the patients who participated in this study. We also thank Judy Jakubowski and Jenna Schulcz for the countless hours of hard work and dedication in seeing this study to completion. We also thank the following individuals and groups (listed alphabetically) for their assistance with this study: Gad Alpan; Behavioral Pharmacology Research Unit clinic, dispensary and pharmacy staff; Center for Addiction and Pregnancy staff; Robin Clay; Ed Cone; Data Safety Monitoring Board members (J.T. Christmas, Joseph Collins, Paul Fudala, Charles Gorodetzky, Karol Kaltenbach, and Sidney Schnoll); Meade Eggelston; Joan Hamilton, Chuka Jenkins; Johns Hopkins Bayview Medical Center General Clinical Research Center staff, Johns Hopkins Bayview Medical Center Labor and Delivery, pediatric, NICU and A2West staff; Sherri Kacinko; Tim Mudric; Tina Robilotto; Patricia Suess, Martha Velez, and Vickie Walters. Dr. Johnson is now employed by Reckitt Benckiser (the manufacturer of buprenorphine). This research was supported by grants DA R01 12220 from the National Institute on Drug Abuse and M01RR-02719 from the General Clinical Research Centers Program of the National Center of Research Resources, National Institutes of Health. ",

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doi = "10.1016/j.drugalcdep.2004.11.013",

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T1 - Buprenorphine versus methadone in the treatment of pregnant opioid-dependent patients

T2 - Effects on the neonatal abstinence syndrome

AU - Jones, Hendree E.

AU - Johnson, Rolley E.

AU - Jasinski, Donald R.

AU - O'Grady, Kevin E.

AU - Chisholm, Christian A.

AU - Choo, Robin E.

AU - Crocetti, Michael

AU - Dudas, Robert

AU - Harrow, Cheryl

AU - Huestis, Marilyn A.

AU - Jansson, Lauren M.

AU - Lantz, Michael

AU - Lester, Barry M.

AU - Milio, Lorraine

N1 - Funding Information: We are indebted to the patients who participated in this study. We also thank Judy Jakubowski and Jenna Schulcz for the countless hours of hard work and dedication in seeing this study to completion. We also thank the following individuals and groups (listed alphabetically) for their assistance with this study: Gad Alpan; Behavioral Pharmacology Research Unit clinic, dispensary and pharmacy staff; Center for Addiction and Pregnancy staff; Robin Clay; Ed Cone; Data Safety Monitoring Board members (J.T. Christmas, Joseph Collins, Paul Fudala, Charles Gorodetzky, Karol Kaltenbach, and Sidney Schnoll); Meade Eggelston; Joan Hamilton, Chuka Jenkins; Johns Hopkins Bayview Medical Center General Clinical Research Center staff, Johns Hopkins Bayview Medical Center Labor and Delivery, pediatric, NICU and A2West staff; Sherri Kacinko; Tim Mudric; Tina Robilotto; Patricia Suess, Martha Velez, and Vickie Walters. Dr. Johnson is now employed by Reckitt Benckiser (the manufacturer of buprenorphine). This research was supported by grants DA R01 12220 from the National Institute on Drug Abuse and M01RR-02719 from the General Clinical Research Centers Program of the National Center of Research Resources, National Institutes of Health.

PY - 2005/7/1

Y1 - 2005/7/1

N2 - This study was designed to compare the neonatal abstinence syndrome (NAS) in neonates of methadone and buprenorphine maintained pregnant opioid-dependent women and to provide preliminary safety and efficacy data for a larger multi-center trial. This randomized, double-blind, double-dummy, flexible dosing, parallel-group controlled trial was conducted in a comprehensive drug-treatment facility that included residential and ambulatory care. Participants were opioid-dependent pregnant women and their neonates. Treatment involved daily administration of either sublingual buprenorphine or oral methadone using flexible dosing of 4-24 mg or 20-100 mg, respectively. Primary a priori outcome measures were: (1) number of neonates treated for NAS; (2) amount of opioid agonist medication used to treat NAS; (3) length of neonatal hospitalization; and (4) peak NAS score. Two of 10 (20%) buprenorphine-exposed and 5 of 11 (45.5%) methadone-exposed neonates were treated for NAS (p = .23). Total amount of opioid-agonist medication administered to treat NAS in methadone-exposed neonates was three times greater than for buprenorphine- exposed neonates (93.1 versus 23.6; p = .13). Length of hospitalization was shorter for buprenorphine-exposed than for methadone-exposed neonates (p = .021). Peak NAS total scores did not significantly differ between groups (p = .25). Results suggest that buprenorphine is not inferior to methadone on outcome measures assessing NAS and maternal and neonatal safety when administered starting in the second trimester of pregnancy.

AB - This study was designed to compare the neonatal abstinence syndrome (NAS) in neonates of methadone and buprenorphine maintained pregnant opioid-dependent women and to provide preliminary safety and efficacy data for a larger multi-center trial. This randomized, double-blind, double-dummy, flexible dosing, parallel-group controlled trial was conducted in a comprehensive drug-treatment facility that included residential and ambulatory care. Participants were opioid-dependent pregnant women and their neonates. Treatment involved daily administration of either sublingual buprenorphine or oral methadone using flexible dosing of 4-24 mg or 20-100 mg, respectively. Primary a priori outcome measures were: (1) number of neonates treated for NAS; (2) amount of opioid agonist medication used to treat NAS; (3) length of neonatal hospitalization; and (4) peak NAS score. Two of 10 (20%) buprenorphine-exposed and 5 of 11 (45.5%) methadone-exposed neonates were treated for NAS (p = .23). Total amount of opioid-agonist medication administered to treat NAS in methadone-exposed neonates was three times greater than for buprenorphine- exposed neonates (93.1 versus 23.6; p = .13). Length of hospitalization was shorter for buprenorphine-exposed than for methadone-exposed neonates (p = .021). Peak NAS total scores did not significantly differ between groups (p = .25). Results suggest that buprenorphine is not inferior to methadone on outcome measures assessing NAS and maternal and neonatal safety when administered starting in the second trimester of pregnancy.

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Buprenorphine versus methadone in the treatment of pregnant opioid-dependent patients: Effects on the neonatal abstinence syndrome

Abstract

Keywords

ASJC Scopus subject areas

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