The Andalusian trial on heroin-assisted treatment
In 2003, a randomised controlled trial (RCT) comparing injected diacetylmorphine and oral methadone was carried out in Andalusia, Spain. The subsequent follow-up study evaluated the health and drug use status of participants, 2 years after the completion of the trial. This follow-up cohort study was carried out between March and August 2006. Data collected included information on socio-demographics, drug use, health and health-related quality of life. Patients who received HAT showed better outcomes compared with those not on HAT. The results of this study strengthen the evidence showing that HAT can improve and stabilise the health of long-term heroin users with severe comorbidities and high mortality.
We compared data collected before randomisation and at 2 years for the following three groups: those currently on heroin-assisted treatment (C-HAT), those who have discontinued HAT (D-HAT), and those who have never received HAT (N-HAT). From the total 62 randomised participants in 2003, 54 (87%) were interviewed for this study. Participants were distributed as follow: C-HAT 44.4% (24), N-HAT 22.2% (12) and D-HAT 33.3% (18). Illicit heroin use had a statistically significant decrease in the three groups from baseline to 2 years post trial. Mean days of heroin use were 2.42 (SD = 3.02); 6.56 (SD = 9.48) and 13.92 (SD = 12.59) for the C-HAT, D-HAT and N-HAT groups, respectively. Those currently on HAT were the only group that sustained at 2 years, their marked improvement in health after 9 months of treatment during the trial period.
In 2005, 59.9% of the Spanish population indicated that the medical administration of heroin to solve the drug problem was ‘a very important measure’. However, the current National law does not allow heroin prescription beyond clinical research in RCTs. This places researchers, clinicians and administrations in a contradictory position: Why would we engage in a RCT to answer a question that five other studies have already provided? If we know HAT is effective, why would we ask this severely affected population to participate in a RCT? Why would we support a treatment that can only be provided through ‘compassionate’ use?
Urgent measures are needed to make available other substitution options, aside from methadone, in order to attract and retain opioid users into treatment. HAT clinics are highly controversial and expensive, and as a result, few administrations and research teams pursue its approval and implementation. In Andalusia, supervised HAT clinics did not move forward mostly owing to the drastic decline of heroin injectors (less than 10% are mainly injectors). Thus, research in this Autonomous Community (and possibly others to join) is now focused in non-injected opioids for substitution, capable of being integrated in the MMT system.
The results of this study make evident that HAT has a role in the addiction treatment system for a small group of severely affected opioid-dependent individuals. This study also strengthens the importance of HAT in the stabilisation and improvement of physical and mental health of a group of long-term heroin users with severe comorbidities and high mortality. The impact on the health-care system would be drastic if this cohort remains untreated.
Drug and Alcohol Review, 29, 75–80