title: NAOMI: The trials and tribulations of implementing a heroin assisted treatment study in North America.
abstract: 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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov registration number: NCT00175357.
authors.affiliation: CIHR Canadian HIV Trials Network and the Centre for Health Evaluation & Outcome Sciences (CHEOS), Vancouver, BC, Canada. cgartry@shaw.ca
authors.forename: Candice C
authors.initials: CC
authors.lastname: Gartry
authors.forename: Eugenia
authors.initials: E
authors.lastname: Oviedo-Joekes
authors.forename: Nancy
authors.initials: N
authors.lastname: Laliberté
authors.forename: Martin T
authors.initials: MT
authors.lastname: Schechter