Page last updated June 9, 2020 by Doug McVay, Editor/Senior Policy Analyst.

51. North American Opiate Medication Initiative (NAOMI)

"The North American Opiate Medication Initiative (NAOMI) is a carefully controlled (clinical trial) that will test whether medically prescribed heroin can successfully attract and retain street-heroin users who have not benefited from previous repeated attempts at methadone maintenance and abstinence programs.
"The NAOMI study will enroll 470 participants at three sites in Vancouver, Montreal and Toronto. The Toronto and Montreal sites are expected to begin recruitment this spring.
"Each site will enroll about 157 participants. About half of these volunteers will be assigned to receive pharmaceutical-grade heroin (the experimental group) and half will receive methadone (the control group). The prescribed heroin will be self-administered under careful medical supervision within a specially designed clinic. Those in the heroin group will be treated for 12 months then transitioned, over three months, into either methadone-maintenance therapy or another treatment program. The researchers expect a 6-9 month recruitment period, so that the total time to complete the study will be 21 to 24 months."

Health Canada News Release, "North America's First Clinical Trial Of Prescribed Heroin Begins Today," (Vancouver: February. 9, 2005).

52. Heroin Maintenance - Research - North American Opioid Medication Initiative

18. What was NAOMI?
"NAOMI was North America’s first-ever clinical trial of prescribed heroin that took place from 2005 to 2008.
"It was led by researchers from PHC and UBC, and tested whether medically prescribed heroin (diacetylmorphine) was more effective than methadone therapy for individuals with chronic heroin addiction who were not benefiting from other conventional treatments.
"19. Who participated in the NAOMI study?
"NAOMI enrolled 251 chronic, heroin dependent participants (192 in Vancouver and 59 in Montreal)."

"24. What did NAOMI find?
"The NAOMI Trial results, published in the prestigious medical publication the New England Journal of Medicine, showed that participants treated with diacetylmorphine reported improved physical and mental health, were 62 per cent more likely to remain in addiction treatment and 40 per cent less likely to take illegal drugs and commit crimes to support their habit than were those treated with methadone.
"After a year, 88 per cent of those treated with diacetylmorphine remained in treatment, compared with 54 per cent in the methadone group.
"Data from NAOMI and other long-term studies with medically prescribed heroin show that many of the patients of these studies also transition from injection to oral treatments, detox programs and abstinence."

"25. What happened to the NAOMI participants after they completed the study?
"Doctors were unable to secure approval from the federal government to give patients diacetylmorphine.
"All participants who received injection medication were encouraged to switch to methadone.
"Providence agreed to provide interim funding for the continued operations of a methadone program at the clinic site. SALOME was designed to continue the work of NAOMI."

"SALOME Clinical Trial Questions and Answers," Providence Healthcare, Vancouver, British Columbia, last accessed March 3, 2017.

53. North American Opioid Medication Initiative

"1. Heroin-assisted therapy proved to be a safe and highly effective treatment for people with chronic, treatment-refractory heroin addiction. Marked improvements were observed including decreased use of illicit “street” heroin, decreased criminal activity, decreased money spent on drugs, and improved physical and psychological health.
"2. The NAOMI trial attracted the most chronic and marginalized heroin users who were outside the treatment system and continued to use heroin despite numerous previous treatment attempts. Both heroin-assisted therapy and optimized methadone maintenance treatment achieved high retention rates and remarkable response rates in this difficult-to-treat group.
"3. Contrary to pre-existing concerns, the treatment clinics appeared to have no negative impacts on the surrounding neighbourhoods.
"4. Participants on hydromorphone did not distinguish this drug from heroin. Moreover, hydromorphone appeared to be equally effective as heroin although the study was not designed to test this conclusively. If this were proven to be true, hydromorphone-assisted therapy could offer legal, political and logistical advantages over heroin and could be made more widely available."

"Reaching the Hardest to Reach–Treating the Hardest-to-Treat," The NAOMI Study Team (Ottawa, Ontario: Canadian Institutes of Health, October 17, 2008), pp. 2 and 18.

54. Findings from the North American Opiate Medication Initiative

"Our study had two primary findings. First, we found that most study participants were motivated for treatment, despite not accessing it in at least the past 6 months (as per trial entry criteria). This may be the result of a lack of accessible or attractive treatment options available to them. Second, we found that baseline motivation for treatment did not predict retention in either HAT [heroin assisted treatment] or MMT [methadone maintenance treatment], however motivated patients receiving HAT were more likely to achieve response than unmotivated patients. While HAT is likely to retain patients regardless of motivational status, success in treatment, in terms of decreases in illicit drug use and crime, is more likely among motivated patients, as measured in our study. Further, HAT was statistically significantly more effective than MMT on each of the outcomes assessed."

Nosyk, Bohdan; Geller, Josie; Guh, Daphne P.; Oviedo-Joekes, Eugenia; Brissette, Suzanne; Marsh, David C.; Schechter, Martin T.; Anis, Aslam H., "The effect of motivational status on treatment outcome in the North American Opiate Medication Initiative (NAOMI) study," Drug and Alcohol Dependence (Philadelphia, PA: College on Problems of Drug Dependence, September 2010), pp. 3-4.

55. Comparison of Effectiveness of Heroin-Assisted Treatment and Methadone Maintenance Treatment, by Gender

"The present study investigated treatment response and retention by gender in North America’s first randomized controlled trial of injectable diacetylmorphine [DAM]. DAM showed greater effectiveness than MMT with respect to treatment retention and response at 12 months for both men and women, although there were significant treatment differences in more sub-scores for men than women. There were no gender differences in overall clinical response and retention at 12 months in the DAM and MMT groups."

Oviedo-Joekesa, Eugenia; Guh, Daphne; Brissette, Suzanne; Marchand, Kirsten; Marsh, David; Chettiarb, Jill; Nosyk, Bohdan; Krausz, Michael; Anisa, Aslam; Schechtera, Martin T., "Effectiveness of diacetylmorphine versus methadone for the treatment of opioid dependence in women," Drug and Alcohol Dependence, (Philadelphia, PA: College on Problems of Drug Dependence, September 2010), p. 4.

56. What is the SALOME clinical trial?

"The Study to Assess Longer-term Opioid Medication Effectiveness (SALOME) is a clinical study that tests alternative treatments for people with chronic heroin addiction who are not benefiting sufficiently from available treatments such as oral methadone.

"SALOME compared two medications – diacetylmorphine, the active ingredient of heroin, and hydromorphone (HDM), a legal, licensed pain medication.

"Studies in Canada and Europe have demonstrated that treatment with diacetylmorphine is more effective than oral methadone for some of the most vulnerable heroin users. HDM has now been shown to be as good as diacetylmorphine and should now become an alternative for those currently not benefitting from methadone and other treatments, and be integrated in the treatment continuum available through licensed doctors."

"SALOME Clinical Trial Questions and Answers," Providence Healthcare (Vancouver, British Columbia: 2016).

57. How are SALOME and NAOMI trials related?

"The NAOMI study provided injectable HDM to a small group of participants. An unexpected finding was that many participants couldn’t tell the difference between the effects of diacetylmorphine and HDM.

"However, the small number of participants receiving HDM did not permit researchers to draw any definite and scientifically valid conclusions as to the efficacy of HDM as a treatment option.

"Therefore, the SALOME investigators designed a study to test this hypothesis.

"SALOME aimed to determine alternative treatments for people with chronic heroin addiction not benefitting sufficiently from available treatments such as oral methadone."

"SALOME Clinical Trial Questions and Answers," Providence Healthcare (Vancouver, British Columbia: 2016).

58. Support for Insite

Vancouver's Insite

"Since its inception, Insite has been subject to an independent review by a team of physicians and scientists put in place to provide an 'arm’s length' evaluation of the program. The results of this scientific evaluation have been published in peer-reviewed academic journals and have indicated that Insite has reduced unsafe injection practices, public disorder, overdose deaths and HIV/Hepatitis while increasing uptake of addiction services and detox [8]. To date, there have been over three-dozen peer-reviewed papers evaluating Insite published making it one of the most evaluated healthcare programs in the history of Canada [9-38]. In light of the evidence, the program has garnered widespread support from Canadian physicians, scientists and healthcare professionals."

Small, Dan, "An appeal to humanity: legal victory in favour of North America’s only supervised injection facility: Insite," Harm Reduction Journal (London, United Kingdom: October 2010), Vol. 7, p. 3.

59. Insite, Canada's First Supervised Consumption Facility

"Insite opened on 21 September of 2003 under an exemption granting it status as a scientific pilot study until 12 September 2006. The primary goals of the program are: (1) to reach a marginalized group of IDUs with healthcare and supports who would otherwise be forced to use drugs in less safe settings (2) to reduce dangerous injection practices (syringe sharing) thereby reducing the risk of infectious diseases like HIV and HCV; and (3) to reduce fatal overdoses in the population of people that use the facility. The program also aims to provide referrals to treatment and detoxification, reduce public disorder (public injection) and validate the personhood of a deeply stigmatized target population."

Small, Dan, "An appeal to humanity: legal victory in favour of North America’s only supervised injection facility: Insite," Harm Reduction Journal (London, United Kingdom: October 2010), Vol. 7, p. 1.

60. Studies Show Many Positive Benefits From Supervised Consumption Facilities

"The British Columbia Centre for Excellence in HIV/AIDS was commissioned to evaluate Insite. A study published in 2006 showed that there was an increase in uptake of detoxification services and addiction treatment.13 Another study published that year showed that Insite did not result in increased relapse among former drug users, nor was it a negative influence on those seeking to stop drug use.14 Results of studies using mathematical modelling showed that about one death from overdose was averted per year by Insite.1 A subsequent study estimated 2–12 deaths averted per year.15 Although these studies did not have sufficient power to detect any difference in incidence of blood-borne infections, Kerr and colleagues did find that Insite users were 70% less likely to report needle-sharing than those who did not use the facility.16 Before the opening of Insite, those same individuals reported needle-sharing that was on par with cohort averages. As for public order, Wood and colleagues found that there was no increase in crime following the opening of the facility.17 In fact, there had been statistically significant decreases in vehicle break-ins and theft, as well as decreases in injecting in public places and injection-related litter."

Dooling, Kathleen and Rachlis, Michael, "Vancouver’s supervised injection facility challenges Canada’s drug laws," Canadian Medical Association Journal (Ottawa, Ontario: September 21, 2010), Vol. 182, Issue 13, p. 1441.