Design considerations for point-of-care clinical trials comparing methadone and buprenorphine treatment for opioid dependence in pregnancy and for neonatal abstinence syndrome.

Abstract

RATIONALE:

In recent years, the U.S. has experienced a significant increase in the prevalence of pregnant opioid-dependent women and of neonatal abstinence syndrome (NAS), which is caused by withdrawal from in-utero drug exposure. While methadone-maintenance currently is the standard of care for opioid dependence during pregnancy, research suggests that buprenorphine-maintenance may be associated with shorter infant hospital lengths of stay (LOS) relative to methadone-maintenance. There is no "gold standard" treatment for NAS but there is evidence that buprenorphine, relative to morphine or methadone, treatment may reduce LOS and length of treatment.

DESIGN:

Point-of-care clinical trial (POCCT) designs, maximizing external validity while reducing cost and complexity associated with classic randomized clinical trials, were selected for two planned trials to compare methadone to buprenorphine treatment for opioid dependence during pregnancy and for NAS. This paper describes design considerations for the Medication-assisted treatment for Opioid-dependent expecting Mothers (MOMs; estimated N = 370) and Investigation of Narcotics for Ameliorating Neonatal abstinence syndrome on Time in hospital (INFANTs; estimated N = 284) POCCTs, both of which are randomized, intent-to-treat, two-group trials. Outcomes would be obtained from participants' electronic health record at three participating hospitals. Additionally, a subset of infants in the INFANTs POCCT would be from mothers in the MOMs POCCT and, thus, potential interaction between medication treatment of mother and infant could be evaluated.

CONCLUSION:

This pair of planned POCCTs would evaluate the comparative effectiveness of treatments for opioid dependence during pregnancy and for NAS. The results could have a significant impact on practice.

• Authors: Theresa Winhusen, Christine Wilder, Scott L Wexelblatt, Jeffrey Theobald, Eric S Hall, Daniel Lewis, James Van Hook, Michael Marcotte
• Journal: Contemporary clinical trials (Contemp Clin Trials) Vol. 39 Issue 1 Pg. 158-65 (Sep 2014) ISSN: 1559-2030 [Electronic] United States
• PMID: 25183042 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)
• Copyright: Copyright © 2014 Elsevier Inc. All rights reserved.

Chemical References

• Buprenorphine
• Methadone

Topics

• Adult
• Birth Weight
• Buprenorphine (therapeutic use)
• Female
• Humans
• Infant, Newborn
• Length of Stay
• Methadone (therapeutic use)
• Neonatal Abstinence Syndrome (drug therapy)
• Opiate Substitution Treatment (methods)
• Opioid-Related Disorders (drug therapy)
• Pregnancy
• Pregnancy Complications (drug therapy)
• Research Design