Consideration of a North American heroin-assisted clinical trial for the treatment of opiate-dependent individuals.

Untreated opiate addiction remains a major public health problem in North America (US and Canada). Increased morbidity and mortality as well as criminal behavior related to untreated opiate dependence constitute significant social and economic burdens. While the principal treatment modality to opiate addiction in North America has been methadone treatment since the 1960s, its reach and effectiveness has been limited; at any given time, only about 25% (US) and 15-20% (Canada) of all opiate addicts are in methadone treatment. Reasons for low levels of treatment participation among this subset of users include perceptions among users that treatment programs are punitive and that the medication is fraught with side effects. In the meantime, alternatives to methadone have been recently approved or are in development, including levo-alpha acetylmethadol and buprenorphine. However, the extent to which they will solve the current problem is still unknown, and therefore development of additional treatment strategies needs to continue. Recent studies of heroin-assisted treatment in Europe (Switzerland, the Netherlands and Great Britain) produced preliminary yet encouraging results in attracting and retaining long-term, treatment-resistant addicts in treatment, as well as improving treatment outcomes. However encouraging, the North American context differs from Europe. A study performed in North America would provide critical information on whether utilizing injectable opiates enhances the overall therapeutic attractiveness and effectiveness of substance abuse treatment to a subset of recalcitrant users. Implications of positive results would expand the continuum of effective interventions in the US and Canada, and increase the number of long-term, treatment-resistant opiate addicts in treatment.