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Prisoners with a history of heroin use by injection have a high risk of drug\u2010related death in the first weeks after prison\u2010release. The N\u2010ALIVE trial was planned as a large prison\u2010based randomised controlled trial (RCT) to test the effectiveness of naloxone\u2010on\u2010release in the prevention of fatal opiate overdoses soon after release. The N\u2010ALIVE pilot trial was conducted to test the main trial's assumptions on recruitment of prisons and prisoners, and the logistics for ensuring that participants received their N\u2010ALIVE pack on release.<\/jats:p><\/jats:sec><jats:sec><jats:title>Design and Methods<\/jats:title><jats:p>Adult prisoners who had ever injected heroin, were incarcerated for \u22657\u2009days and were expected to be released within 3\u2009months were eligible. Participants were randomised to receive, on liberation, a pack containing a single \u2018rescue\u2019 injection of naloxone or a control pack with no naloxone syringe. The trial was double\u2010blind prior to prison\u2010release.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>We randomised 1685 prisoners (842 naloxone; 843 control) across 16 prisons in England. We stopped randomisation on 8 December 2014 because only one\u2010third of administrations of naloxone\u2010on\u2010release were to the randomised ex\u2010prisoner; two\u2010thirds were to others whom we were not tracing.<\/jats:p><\/jats:sec><jats:sec><jats:title>Discussion and Conclusions<\/jats:title><jats:p>Prevention RCTs are seldom conducted within prisons; we demonstrated the feasibility of conducting a multi\u2010prison RCT to prevent fatality from opioid overdose in the outside community. We terminated the N\u2010ALIVE trial due to the infeasibility of individualised randomisation to naloxone\u2010on\u2010release. Large RCTs are feasible within prisons.<\/jats:p><\/jats:sec>","DOI":"10.1111\/dar.12592","type":"journal-article","created":{"date-parts":[[2017,9,21]],"date-time":"2017-09-21T06:32:42Z","timestamp":1505975562000},"page":"487-498","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":12,"title":["Methods for delivering the UK's multi\u2010centre prison\u2010based naloxone\u2010on\u2010release pilot randomised trial (N\u2010ALIVE): Europe's largest prison\u2010based randomised controlled trial"],"prefix":"10.1111","volume":"37","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6424-0554","authenticated-orcid":false,"given":"Angela Mary","family":"Meade","sequence":"first","affiliation":[{"name":"MRC Clinical Trials Unit at University College London  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sheila Macdonald","family":"Bird","sequence":"additional","affiliation":[{"name":"MRC Biostatistics Unit University of Cambridge, Institute of Public Health  Cambridge UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John","family":"Strang","sequence":"additional","affiliation":[{"name":"National Addiction Centre, King's College London  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tracey","family":"Pepple","sequence":"additional","affiliation":[{"name":"MRC Clinical Trials Unit at University College London  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laura Lea","family":"Nichols","sequence":"additional","affiliation":[{"name":"MRC Clinical Trials Unit at University College London  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Monica","family":"Mascarenhas","sequence":"additional","affiliation":[{"name":"MRC Clinical Trials Unit at University College London  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Louise","family":"Choo","sequence":"additional","affiliation":[{"name":"MRC Clinical Trials Unit at University College London  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mahesh Kumar Bhikhubhai","family":"Parmar","sequence":"additional","affiliation":[{"name":"MRC Clinical Trials Unit at University College London  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2017,9,21]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.1136\/emj.2003.009613"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1360-0443.2003.00264.x"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1360-0443.2007.02081.x"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0376-8716(03)00187-X"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0376-8716(02)00024-8"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.1186\/1747-597X-4-1"},{"key":"e_1_2_11_8_1","doi-asserted-by":"publisher","DOI":"10.3399\/bjgp11X613106"},{"key":"e_1_2_11_9_1","doi-asserted-by":"publisher","DOI":"10.3109\/16066350802531273"},{"key":"e_1_2_11_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(14)62338-2"},{"key":"e_1_2_11_11_1","doi-asserted-by":"publisher","DOI":"10.2105\/AJPH.2014.302498"},{"key":"e_1_2_11_12_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.a1655"},{"key":"e_1_2_11_13_1","first-page":"309","article-title":"From evidence to policy: the Scottish National Naloxone Programme","volume":"19","author":"McAuley A","year":"2012","journal-title":"Drugs (Abingdon Engl)"},{"key":"e_1_2_11_14_1","first-page":"66","article-title":"Take\u2010home naloxone to prevent fatalities from opiate\u2010overdose: protocol for Scotland's public health policy evaluation, and a new measure to assess impact","volume":"22","author":"Bird SM","year":"2014","journal-title":"Drugs (Abingdon Engl)"},{"key":"e_1_2_11_15_1","unstructured":"BennettT HollowayK. 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