drug-related deaths (drds) soon after release: i effectiveness on trial: ii naloxone (heroin...
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Drug-Related Deaths (DRDs) soon after release: I
Effectiveness on Trial: II Naloxone (heroin antidote) on
release to reduce overdose deaths
1991 WASH Willing [ethical]
Anonymous [no deductive disclosure]
Saliva & linked self-Q [high volunteer rate]
HIV surveillance
Linked to self-Q on risks [frank answers]
Overdose deaths in 2 weeks after HIV injectors’ releases from HMP
Edinburgh [1983-94]
8 times higher than for comparable other fortnights at liberty (p < 0.01)
7 drug-related deaths, 6 from overdose.
1. Seaman, Brettle & Gore: BMJ (1998)
2. Male index releases from Scottish prisons in July to Dec. 1996-99
[Bird & Hutchinson: Addiction 2003]
Eligibility set by [B+H]Applied by Scottish Prison Service
[SPS]
maleborn in 1960+ & aged 15-35 years on release
served 14+ days in prison1st release in July-Decembercalendar years: 1996 to 1999
Design assumptions
1. ~ 20,000 eligible releases
2. At least 40% adult & 20% young offender male index releases = injectors (IDUs)
3. Drugs-Related Deaths (DRDs): mainly IDUs
4. In 1990s: one DRD per 3000 recently released IDU-days (not 1 per 1000, as Seaman)
5. Relative Risk: 1st fortnight DRDs = 4
Drugs-related deaths in fortnight after prison: 19 486 male ex-prisoners, aged
15-35 years, released after 14+days’ incarceration
DEATHS 1st 2 weeks
subsequent 5 fortnights
RELATIVERISK(95% CI)
Drugs-related
34 23(11 in 2nd fortnight +12 in next 8 wks)
7 (3 to 16)
Other causes
3 18 0.8 (0.2 to 2.4)
Internationally, 6 major studies
Merrall et al., 2010 Addiction Studies
DRDs; pys at risk
DRD rate per 1 000 pys
1st fortnight Relative
Risk(95% CI)1st
fortnight2nd
fortnightnext 8 weeks
UK (E&W +
Scotland)
92; 2 588
36
20; 2 547
8
42; 10 795
4
7.5(5.7 to 9.9)
Australia(NSW & Western)
187; 7 759
24
64; 7 416
9
144; 27 334
5
4.0(3.4 to 4.8)
USA (Washington State & New Mexico prisons)
27; 1 466
18
8; 462
17
5; 1 426
4
3; 462
6
10; 5 409
2
10; 1 845
5
8.4(5.0 to 14.2)
3.1(1.3 to 7.1)
Why prisoners + outside implications?
Need + Research Efficiency
i) concentration of adult
heroin injectors (~ 40%)ii) at very high riskiii) well-defined period
soon after releaseiv) Third to half injectors
in prison in past yearv) proof-of-principle for
other settings
1 in 8 Scottish DRDs occurs in 4 weeks after
release!
Prison-based interventions
a) Information leaflet: how to avoid overdose risk after release
b) Naloxone on release: heroin antidote
UK’s Advisory Council on the Misuse of
Drugs: already on the case in 2000 . . .
2005
Naloxone was added to UK’s exempt list
of Prescription Only
Medicinesfor administration
by anyone in an emergency to
save life
N-ALIVE: randomise 56,000 eligible prisoners in 50 UK prisons in 5 years
“Good luck, Prof Bird . . . “
Three musketeers (2008): John Strang, Max Parmar & Sheila Bird
Design assumptions: N-ALIVE
Eligibility: 18-44 years, history of heroin injection, 7+ days’ incarceration.
1. At 80% of overdoses, some-one else is present
2. 75% chance ex-prisoner carries Naloxone in 1st 4 weeks post-release; 50% chance in next 8 weeks
3. 50% chance that Naloxone is administered by present other.
Effectiveness in 1st 4 weeks = 30% Effectiveness in weeks 5 to 12 = 20%
4. 21st C: One overdose death in 1st 4 weeks per 200 ever-IDUs randomised to control group.
5. Contamination . . .
Prison-based, with-consent* RCT for 56,000 pre-release adult IDUs
Expected drugs deaths
1st 4 weeks after release
Next 8 weeks
after release
Controls
[28,000 IDUs]140 35
Naloxone
[28,000 IDUs] 98 28
UK-affordable cost of Naloxone
If CE threshold is £20K ($40K) per
life year gained, &
Naloxone prevents
42 drug deaths in 1st+2nd fortnight per
28,000 IDU releases
Per injector-inmate, UK’s NHS can afford
to pay:
{42 * £20K }/28,000 = £30
for pre-release
Naloxone
N-ALIVE designed to fit with UK prison routines . . .
Induction: drug awareness + N-ALIVE DVD 1-1 consent: each randomized prisoner
has an assigned N-ALIVE pack.Assigned N-ALIVE packs held in Pharmacy or
Prisoner’s valuables.
Prisoner escort release from court . . .Date of release is critical.
*N-ALIVE DVD copy for prisoner’s family ** Re-randomization of recidivists . . . ?
N-ALIVE cleaves to prison routines
Prisoner-induction includes drugs awareness session: N-ALIVE DVD added.
(educates peers/family re N-ALIVE & Naloxone)
N-ALIVE addiction workers: informed consent, randomisation, liaison with
pharmacy & Clinical Trials Unit re release dates.
(half-time is research activity)
N-ALIVE pack handled by pharmacy & escort staff as a medicine that accompanies
prisoner to court, on transfers. (issued only on release)
Informed consent by prisoners
• Treatments = Naloxone or control pack at release [information leaflet & prepaid reply card]
• Confidential database linkage to deaths register [and NFO A&E admissions in N-ALIVE PILOT RCT]
• Random assignment ~ blinded until release
• Follow-up of recidivists via brief self-Q (unique #)
• Single phone contact in 1st or 2nd fortnight after release (for HALF only of randomised participants & in PILOT RCT only . . . Because phone-contact contaminates N-ALIVE intervention)
N-ALIVE Recidivist self-Q
RCT flag against prisoner number so that on re-incarceration [applies to 60% of IDUs]
IDU attends prison health to answer no-names, selotape-seal, self-Q re
overdose(s) witnessed [fatal/non], overdose(s) experienced [alone/accompanied] & naloxone [use/disposal/acquisition/where kept] &
heroin use.
Pilot N-ALIVE . . . & kicking via
Medical Research Council’s Clinical Trials Unit: welcomes international collaborations
Scottish Prison Service (Karen Norrie, Andrew Fraser; Ruth Parker, Stephen Heller-Murphy;
governors, security & HC)
Health Department/Prison Service in E&W (Dave Marteau, Martin Lee)
Prisoners in both services