The North American Opiate Medication Initiative (NAOMI) was North America’s first-ever clinical trial of prescribed heroin that took place from 2005 to 2008. NAOMI was a randomized trial aimed at testing 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.
The results showed that patients treated with injectable diacetylmorphine were more likely to stay in treatment and more likely to reduce their use of illegal drugs and other illegal activities than patients treated with oral methadone.
The NAOMI study provided injectable HDM, a licensed pain medication, 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, but it did form the basis for SALOME.
Should HDM be proven to be as effective as diacetylmorphine, the benefits of this type of treatment may be achievable without the legal barriers and stigma associated with heroin. Therefore, the NAOMI investigators designed a study to test this hypothesis.
The Study to Assess Longer-term Opioid Medication Effectiveness (SALOME) was a clinical trial that tested alternative treatments for people with chronic heroin addiction who were not benefitting sufficiently from current known treatments. About 10% of the heroin-dependent population does not respond sufficiently from available treatments such as oral methadone.
SALOME compared two similar medications – diacetylmorphine, the active ingredient of heroin, and HDM. This study also tested if those effectively treated with these two injectable medications could be successfully switched and retained to the oral formulations of the medications.
SALOME involved two-stages, with each trial participant remaining for six months in each phase. In stage one, half of the 202 participants were randomized to receive injectable diacetylmorphine, while the other half received injectable HDM. This was a double-blind study — neither the participants nor the researchers or clinical team (other than the pharmacy) were aware of which treatment was being administered. In the second stage, half of the participants were randomized to continue injection treatment exactly as in stage one, while the other half switched to the oral equivalent of the same medication (diacetylmorphine or HDM). The oral version was also provided on a double-blind basis. SALOME concluded in 2015 and the results were published in April 2016.
Once in the study, participants visit the clinic up to three times per day at which, after a pre-treatment assessment (for safety reasons), they receive their medication. After injecting or ingesting their medication, participants are observed until staff determine that it is safe for them to leave. Addiction medicine doctors oversee and monitor the prescriptions for both groups.
Throughout the treatment period, an interdisciplinary team of physicians, nurses, social workers and counselors are available to help participants achieve stability in their life, seek employment and find suitable housing. Some primary care services, HIV, hepatitis C and psychiatric care are also provided. At any time, participants can choose to switch to methadone treatment, to drug-free (abstinence) programs, to detox programs or any other option available.
A research team conducted individual assessments to determine if the treatments are being effective. This team works closely but independently from the clinical team and has no power over clinical decisions.