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

2014 ◽  
Vol 39 (1) ◽  
pp. 158-165 ◽  
Author(s):  
Theresa Winhusen ◽  
Christine Wilder ◽  
Scott L. Wexelblatt ◽  
Jeffrey Theobald ◽  
Eric S. Hall ◽  
...  
2014 ◽  
Vol 19 (3) ◽  
pp. 165-173 ◽  
Author(s):  
Melissa R. Johnson ◽  
David R. Nash ◽  
Mary R. Laird ◽  
Robert C. Kiley ◽  
Michael A. Martinez

OBJECTIVES: To compare the length of wean and abstinence severity in neonatal and pediatric patients with neonatal abstinence syndrome or iatrogenic opioid dependence treated with a pharmacist-managed, methadone-based protocol compared with physician-managed patients treated with either methadone or dilute tincture of opium (DTO). METHODS: This was a prospective, single-centered, interventional evaluation of 54 pharmacist-managed patients versus 53 retrospective, physician-managed patients. Wean duration and severity of neonatal abstinence syndrome were compared between groups using the Student t test. RESULTS: Significantly shorter wean duration in in utero-exposed pharmacist-managed patients compared with patients on physician-managed DTO (11.7 days vs 24.2 days, p < 0.001), but not compared with patients on physician-managed methadone (11.7 days vs 47 days, p = 0.101). No statistically significant difference was seen in wean duration in iatrogenic-exposed pharmacist-managed patients compared with patients on either physician-managed DTO or methadone (8.69 days vs 14 days, p = 0.096) and (8.69 days vs 9.82 days, p = 0.34), respectively. There were significantly fewer abstinence scores >12 in pharmacist-managed patients versus physician-managed DTO, but not physician-managed methadone (2.05 vs 17.3, p = 0.008 and 2.05 vs 74.3, p = 0.119, respectively). Significantly fewer abstinence scores ≥8 × 3 consecutively were seen in pharmacist-managed patients compared with patients on either physician-managed DTO or methadone (2.89 vs 11.9, p = 0.01 and 2.89 vs 24, p < 0.001, respectively). CONCLUSIONS: Use of a pharmacist-managed, methadone-based weaning protocol standardizes patient care and has the potential to decrease abstinence severity and shorten duration of wean versus physician-managed patients exposed to opioids in utero. Additionally, a methadone wean of 10% to 20% per day was well tolerated in both neonatal and pediatric patients.


2015 ◽  
Vol 57 ◽  
pp. 218-219
Author(s):  
Jorgos Eleftheriou ◽  
Rafaella Butera ◽  
Mariapina Gallo ◽  
Lorella Faraoni ◽  
Gioia Contessa ◽  
...  

2019 ◽  
Vol 41 (5) ◽  
pp. 733
Author(s):  
Alison Shea ◽  
Kellie Murphy ◽  
Ariel Dalfen ◽  
John Snelgrove ◽  
Donald Wang

2019 ◽  
Vol 2 (11) ◽  
pp. e1914078 ◽  
Author(s):  
Laura J. Faherty ◽  
Ashley M. Kranz ◽  
Joshua Russell-Fritch ◽  
Stephen W. Patrick ◽  
Jonathan Cantor ◽  
...  

2020 ◽  
Vol 97 ◽  
pp. 6
Author(s):  
Lorella Faraoni ◽  
Georgios Eleftheriou ◽  
Raffaella Butera ◽  
Mariapina Gallo ◽  
Andrea Giampreti ◽  
...  

2017 ◽  
Vol 130 (1) ◽  
pp. 10-28 ◽  
Author(s):  
Uma M. Reddy ◽  
Jonathan M. Davis ◽  
Zhaoxia Ren ◽  
Michael F. Greene

Author(s):  
Rachel Wurmser ◽  
Kirsten Wilkins

This chapter provides a summary of a landmark study in women’s mental health. The study addresses the question of whether buprenorphine is an alternative treatment option to methadone for pregnant women with opioid use disorders. The chapter describes the basics of the study, including funding, location, population studied, study design, interventions, results, and limitations. In short, the study demonstrated that neonates born to mothers with opioid dependence taking buprenorphine during pregnancy required less morphine for the treatment of Neonatal Abstinence Syndrome (NAS), shorter periods of treatment for NAS, and shorter hospital stays compared with neonates born to mothers treated with methadone. The chapter briefly reviews other relevant literature and discusses implications. It concludes with a case to help the reader apply the study to clinical practice.


2019 ◽  
Vol 27 (1) ◽  
pp. 423-431 ◽  
Author(s):  
Masumeh Ghazanfarpour ◽  
Mona Najaf Najafi ◽  
Nasibeh Roozbeh ◽  
Mohamadghasem Etemadi Mashhadi ◽  
Atefeh Keramat-roudi ◽  
...  

Sign in / Sign up

Export Citation Format

Share Document