N-ALIVE shows large clinical trials are feasible in prisons
13 Mar 2017
The results of the largest ever prison-based individually randomised trial have been published in the journal Addiction. The N-ALIVE trial results show that large-scale trials of public health interventions are feasible within prisons.
Between 6,000 and 8,000 drug-related deaths are reported in Europe every year, with opioids, such as heroin, as the major cause. Prisoners with a history of heroin injection are at particularly high risk of heroin overdose soon after they are released, with one death per 200 prisoners released.
The prescription drug naloxone reverses the effects of opioids including heroin, and, in the UK, it can be administered by anyone to save life in an emergency. However, in England it is not routinely given to prisoners with a history of injecting to take home when they are released. Some people were concerned that providing naloxone may encourage more use of heroin, so more evidence was needed to see if naloxone-on-release was a useful public health approach.
A trial big enough to show whether giving naloxone to prisoners when they are released can have an impact on drug-related deaths would need 56,000 prisoners to take part. No trial of that scale in prisons has ever taken place, so N-ALIVE was set up as a pilot, to see if the main trial would be feasible.
N-ALIVE recruited 1685 prisoners from 16 prisons in England between May 2012 and December 2014. They were randomised to one of two groups:
- The naloxone group received a wallet containing an information DVD and a pre-filled syringe of naloxone with separate plunger and needle
- The control group received a wallet with an information DVD, but no naloxone syringe.
At the point of release, the former prisoner was given their N-ALIVE wallet, at which point it was clear to them whether they had been assigned to the naloxone group or the no-naloxone control group. In December 2014 recruitment to N-ALIVE was stopped early, based on interim data from N-ALIVE, and data from Scotland’s National Naloxone Programme. Data from N-ALIVE showed that ex-prisoners were twice as likely to use their naloxone to save someone else’s life as to save their own. In the N-ALIVE pilot trial we were only able to count a reduction in drug-related deaths in those people who were taking part in the trial. This was also the planned outcome measure for the main trial. The interim data meant that the main N-ALIVE trial would be unlikely to be able to detect a reduction in overdose deaths among people taking part in the trial as the naloxone was being used substantially on people outside the trial. Data from Scotland showed that providing naloxone routinely to prisoners on release from prison was associated with a fall in drug-related deaths within four weeks of release.
While the main N-ALIVE trial will not go ahead, the pilot trial has shown that large prison-based trials are feasible, and that prisoners are willing to take part in trials that are relevant to their health. Giving prisoners take-home emergency naloxone on prison release may be a life-saving measure to prevent heroin overdose deaths among ex-prisoners and the wider population.