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NAOMI: The trials and tribulations of implementing a heroin assisted treatment study in North America
BACKGROUND: Opioid addiction is a chronic, relapsing disease and remains a major public health challenge. Despite important expansions of access to conventional treatments, there are still significant proportions of affected individuals who remain outside the reach of the current treatment system an...
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Formato: | Texto |
Lenguaje: | English |
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BioMed Central
2009
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2639576/ https://www.ncbi.nlm.nih.gov/pubmed/19159475 http://dx.doi.org/10.1186/1477-7517-6-2 |
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author | Gartry, Candice C Oviedo-Joekes, Eugenia Laliberté, Nancy Schechter, Martin T |
author_facet | Gartry, Candice C Oviedo-Joekes, Eugenia Laliberté, Nancy Schechter, Martin T |
author_sort | Gartry, Candice C |
collection | PubMed |
description | BACKGROUND: Opioid addiction is a chronic, relapsing disease and remains a major public health challenge. Despite important expansions of access to conventional treatments, there are still significant proportions of affected individuals who remain outside the reach of the current treatment system and who contribute disproportionately to health care and criminal justice costs as well as to public disorder associated with drug addiction. The NAOMI study is a Phase III randomized clinical trial comparing injectable heroin maintenance to oral methadone. The study has ethics board approval at its Montréal and Vancouver sites, as well as from the University of Toronto, the New York Academy of Medicine and Johns Hopkins University. The main objective of the NAOMI Study is to determine whether the closely supervised provision of injectable, pharmaceutical-grade opioid agonist is more effective than methadone alone in recruiting, retaining, and benefiting chronic, opioid-dependent, injection drug users who are resistant to current standard treatment options. METHODS: The case study submitted chronicles the challenges of getting a heroin assisted treatment trial up and running in North America. It describes: a brief background on opioid addiction; current standard therapies for opioid addiction; why there is/was a need for a heroin assisted treatment trial; a description of heroin assisted treatment; the beginnings of creating the NAOMI study in North America; what is the NAOMI study; the science and politics of the NAOMI study; getting NAOMI started in Canada; various requirements and restrictions in getting the study up and running; recruitment into the study; working with the media; a status report on the study; and a brief conclusion from the authors' perspectives. RESULTS AND CONCLUSION: As this is a case study, there are no specific results or main findings listed. The case study focuses on: the background of the study; what it took to get the study started in Canada; the unique requirements and conditions of getting a site, and the study, approved; working with the media; recruitment into the study; a brief status report on the study; and a brief conclusion from the authors' perspectives. TRAIL REGISTRATION: ClinicalTrials.gov registration number: NCT00175357 |
format | Text |
id | pubmed-2639576 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2009 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-26395762009-02-11 NAOMI: The trials and tribulations of implementing a heroin assisted treatment study in North America Gartry, Candice C Oviedo-Joekes, Eugenia Laliberté, Nancy Schechter, Martin T Harm Reduct J Case Study BACKGROUND: Opioid addiction is a chronic, relapsing disease and remains a major public health challenge. Despite important expansions of access to conventional treatments, there are still significant proportions of affected individuals who remain outside the reach of the current treatment system and who contribute disproportionately to health care and criminal justice costs as well as to public disorder associated with drug addiction. The NAOMI study is a Phase III randomized clinical trial comparing injectable heroin maintenance to oral methadone. The study has ethics board approval at its Montréal and Vancouver sites, as well as from the University of Toronto, the New York Academy of Medicine and Johns Hopkins University. The main objective of the NAOMI Study is to determine whether the closely supervised provision of injectable, pharmaceutical-grade opioid agonist is more effective than methadone alone in recruiting, retaining, and benefiting chronic, opioid-dependent, injection drug users who are resistant to current standard treatment options. METHODS: The case study submitted chronicles the challenges of getting a heroin assisted treatment trial up and running in North America. It describes: a brief background on opioid addiction; current standard therapies for opioid addiction; why there is/was a need for a heroin assisted treatment trial; a description of heroin assisted treatment; the beginnings of creating the NAOMI study in North America; what is the NAOMI study; the science and politics of the NAOMI study; getting NAOMI started in Canada; various requirements and restrictions in getting the study up and running; recruitment into the study; working with the media; a status report on the study; and a brief conclusion from the authors' perspectives. RESULTS AND CONCLUSION: As this is a case study, there are no specific results or main findings listed. The case study focuses on: the background of the study; what it took to get the study started in Canada; the unique requirements and conditions of getting a site, and the study, approved; working with the media; recruitment into the study; a brief status report on the study; and a brief conclusion from the authors' perspectives. TRAIL REGISTRATION: ClinicalTrials.gov registration number: NCT00175357 BioMed Central 2009-01-21 /pmc/articles/PMC2639576/ /pubmed/19159475 http://dx.doi.org/10.1186/1477-7517-6-2 Text en Copyright © 2009 Gartry et al; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( (http://creativecommons.org/licenses/by/2.0) ), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Case Study Gartry, Candice C Oviedo-Joekes, Eugenia Laliberté, Nancy Schechter, Martin T NAOMI: The trials and tribulations of implementing a heroin assisted treatment study in North America |
title | NAOMI: The trials and tribulations of implementing a heroin assisted treatment study in North America |
title_full | NAOMI: The trials and tribulations of implementing a heroin assisted treatment study in North America |
title_fullStr | NAOMI: The trials and tribulations of implementing a heroin assisted treatment study in North America |
title_full_unstemmed | NAOMI: The trials and tribulations of implementing a heroin assisted treatment study in North America |
title_short | NAOMI: The trials and tribulations of implementing a heroin assisted treatment study in North America |
title_sort | naomi: the trials and tribulations of implementing a heroin assisted treatment study in north america |
topic | Case Study |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2639576/ https://www.ncbi.nlm.nih.gov/pubmed/19159475 http://dx.doi.org/10.1186/1477-7517-6-2 |
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