Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2012 Nov;107 Suppl 1(0 1):91-7.
doi: 10.1111/j.1360-0443.2012.04043.x.

Effect of hepatitis C virus status on liver enzymes in opioid-dependent pregnant women maintained on opioid-agonist medication

Laura F McNicholas  1 , Amber M Holbrook, Kevin E O'Grady, Hendrée E Jones, Mara G Coyle, Peter R Martin, Sarah H Heil, Susan M Stine, Karol Kaltenbach
Affiliations
Randomized Controlled Trial

Effect of hepatitis C virus status on liver enzymes in opioid-dependent pregnant women maintained on opioid-agonist medication

Laura F McNicholas et al. Addiction. 2012 Nov.

Abstract

Aim: To examine hepatic enzyme test results throughout the course of pregnancy in women maintained on methadone or buprenorphine.

Design: Participants were randomized to either methadone or buprenorphine maintenance. Blood chemistry tests, including liver transaminases and hepatitis C virus (HCV) status, were determined every 4 weeks and once postpartum. As part of a planned secondary analysis, generalized mixed linear models were conducted with aspartate aminotransferase (AST), alanine aminotransferase (ALT) and gamma-glutamyl transferase (GGT) as the dependent variables.

Setting: Six US sites and one European site that provided comprehensive treatment to pregnant opioid-dependent women.

Participants: A total of 175 opioid-dependent pregnant women enrolled in the Maternal Opioid Treatment: Human Experimental Research (MOTHER) study.

Findings: ALT, AST and GGT levels decreased for all subjects across pregnancy trimesters, rising slightly postpartum. HCV-positive subjects exhibited higher transaminases at all time-points compared to HCV-negative subjects, regardless of medication (all Ps < 0.05) condition. Both HCV-positive and negative buprenorphine-maintained participants exhibited lower GGT levels than those who were methadone-maintained (P < 0.05).

Conclusions: Neither methadone nor buprenorphine appear to have adverse hepatic effects in the treatment of pregnant opioid-dependent women.

Trial registration: ClinicalTrials.gov NCT00271219.

PubMed Disclaimer

Conflict of interest statement

Declaration of interests:

The clinical trial was registered with ClinicalTrials.gov (Identifier: NCT00271219; Title: RCT Comparing Methadone and Buprenorphine in Pregnant Women

H.J. discloses that she has received reimbursement for time and travel from Reckitt Benckiser.

KEO’G discloses that he has received reimbursement for time from Reckitt Benckiser.

Figures

Figure 1
Figure 1
Means by HCV status across trimesters: HCV positive (n=66)
Figure 2
Figure 2
Means by HCV Status across trimesters: HCV negative (n= 106)
See this image and copyright information in PMC

References

    1. National Institutes of Health Consensus Development Panel. Effective medical treatment of opiate addiction. JAMA. 1998;280:1936–43. - PubMed
    1. Johnson RE, Jaffe JH, Fudala PJ. A controlled trial of buprenorphine treatment for opioid dependence. JAMA. 1992;267:2750–5. - PubMed
    1. Ling W, Charuvastra C, Collins JF, Batki S, Brown LS, Kintaudi P, et al. Buprenorphine maintenance treatment of opiate dependence: a multicenter randomized clinical trial. Addiction. 1998;93:475–86. - PubMed
    1. Mattick RP, Ali R, White JM, O’Brien S, Wolk S, Danz C. Buprenorphine versus methadone maintenance therapy: a randomized double-blind trial with 405 opioid-dependent patients. Addiction. 2003;98:441–52. - PubMed
    1. Strain EC, Stitzer ML, Liebson IA, Bigelow GE. Comparison of buprenorphine and methadone in the treatment of opiate dependence. Am J Psychiatry. 1994;151:1025–30. - PubMed

Publication types

MeSH terms

Associated data