Dataset Information

Randomized controlled pilot trial of naloxone-on-release to prevent post-prison opioid overdose deaths.

ABSTRACT:

Background and aims

Naloxone is an opioid antagonist used for emergency resuscitation following opioid overdose. Prisoners with a history of heroin injection have a high risk of drug-related death soon after release from prison. The NALoxone InVEstigation (N-ALIVE) pilot trial (ISRCTN34044390) tested feasibility measures for randomized provision of naloxone-on-release (NOR) to eligible prisoners in England.

Design

Parallel-group randomized controlled pilot trial.

Setting

English prisons.

Participants

A total of 1685 adult heroin injectors, incarcerated for at least 7 days pre-randomization, release due within 3 months and more than 6 months since previous N-ALIVE release.

Intervention

Using 1 : 1 minimization, prisoners were randomized to receive on release a pack containing either a single 'rescue' injection of naloxone or a control pack with no syringe.

Measurements

Key feasibility outcomes were tested against prior expectations: on participation (14 English prisons; 2800 prisoners), consent (75% for randomization), returned prisoner self-questionnaires (RPSQs: 207), NOR-carriage (75% in first 4 weeks) and overdose presence (80%).

Findings

Prisons (16) and prisoners (1685) were willing to participate [consent rate, 95% confidence interval (CI) = 70-74%]; 218 RPSQs were received; NOR-carriage (95% CI = 63-79%) and overdose presence (95% CI = 75-84%) were as expected. We randomized 842 to NOR and 843 to control during 30 months but stopped early, because only one-third of NOR administrations were to the ex-prisoner. Nine deaths within 12 weeks of release were registered for 1557 randomized participants released before 9 December 2014.

Conclusions

Large randomized trials are feasible with prison populations. Provision of take-home emergency naloxone prior to prison release may be a life-saving interim measure to prevent heroin overdose deaths among ex-prisoners and the wider population.

SUBMITTER: Parmar MK

PROVIDER: S-EPMC5324705 | biostudies-literature | 2017 Mar

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Randomized controlled pilot trial of naloxone-on-release to prevent post-prison opioid overdose deaths.

Parmar Mahesh K B MK Strang John J Choo Louise L Meade Angela M AM Bird Sheila M SM

Addiction (Abingdon, England) 20161213 3

<h4>Background and aims</h4>Naloxone is an opioid antagonist used for emergency resuscitation following opioid overdose. Prisoners with a history of heroin injection have a high risk of drug-related death soon after release from prison. The NALoxone InVEstigation (N-ALIVE) pilot trial (ISRCTN34044390) tested feasibility measures for randomized provision of naloxone-on-release (NOR) to eligible prisoners in England.<h4>Design</h4>Parallel-group randomized controlled pilot trial.<h4>Setting</h4>En ...[more]

PMID: 27776382

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Project description:IntroductionFatal overdoses from opioids increased four-fold from 1999 to 2009, and they are now the leading cause of death among Americans under 50. Legislation has been passed by every state to increase access to naloxone but dispensing by community pharmacies remains low.ObjectivesThe objective of this study was to pilot test a proactive opioid overdose counseling intervention and a passive naloxone intervention, and the implementation strategies developed to support their delivery, in rural community pharmacies on relevant implementation outcomes.MethodsThe interventions, implementation strategies, and the overall pilot study approach were developed in a collaborative partnership with a regional supermarket pharmacy chain. They selected 2 rural pharmacies to participate in the pilot study and 2 non-intervention pharmacies to serve as comparison sites. Two interventions were pilot tested in the 2 intervention pharmacies: 1)a proactive opioid overdose counseling intervention and 2) a passive naloxone intervention. An explanatory sequential mixed-methods design was utilized to evaluate adoption, feasibility, acceptability, and appropriateness outcomes after the 3-month observation period.ResultsBetween the 2 intervention pharmacies, 130 patients received the opioid overdose counseling intervention. 44 (33.8%) were prescribed and dispensed naloxone. Zero naloxone prescriptions were written or dispensed at the comparison pharmacies. Interviews with pharmacy staff found the interventions to be feasible, acceptable, and appropriate in their settings.ConclusionThis small scale pilot study in partnership with a regional supermarket pharmacy chain had positive results with a third of patients who received the opioid overdose counseling intervention being dispensed naloxone. However, the majority of patients did not receive naloxone indicating additional revisions to the intervention components and/or implementation strategies are needed to improve the overall impact of the interventions.

Project description:IntroductionCommunity programs to teach nonmedical laypeople how to recognize an opioid overdose and effectively resuscitate the victim using naloxone have proliferated recently as a significant component of harm-reduction efforts. Although many such programs target laypeople like first responders or friends and family members of people who use drugs, there are currently no programs that specifically target addiction counselors, despite their work with a client population at high risk of an opioid overdose.MethodsThe four-hour curriculum designed by the authors covered opioid agonist and antagonist pharmacology; opioid toxidrome signs; legal implications and indications for using the naloxone kits; and hands-on training. Participants were two cohorts of addiction counselors and addiction counseling trainees at our institution and an affiliated Opioid Treatment Program methadone clinic. Surveys testing participant knowledge and confidence were conducted at baseline, immediately post-training, six months post-training, and 12 months post-training.ResultsOverall, opioid and naloxone pharmacology knowledge, as well as the confidence to intervene in an overdose emergency, improved among participants in both cohorts. Knowledge scores at baseline (n = 36, median 5/10) improved significantly immediately post-training (n = 31, median 7/10, P < 0.0001, Wilcoxon signed-rank test) and were sustained six (n = 19) and 12 months (n = 11) later. Two participants reported using their naloxone kits to successfully reverse a client overdose in the 12 months after taking the course.DiscussionThese results from our knowledge translation pilot project suggest that our educational program to train addiction counselors in opioid pharmacology and toxicology, allowing them to recognize and respond to an opioid overdose, is feasible and could be effective. Specific barriers to implementing such educational programs include cost, stigma, and unclear best practice for designing and conducting these programs.ConclusionsFurther study of providing opioid pharmacology education and overdose and naloxone training to addiction counselors and counseling trainees appears to be warranted.

Project description:BackgroundDrug overdose is the leading cause of death after release from prison, and this risk is significantly higher among women compared to men. Within the first 2 weeks after release, the risk of death from drug overdose is 12.7 times higher than the general population, with risk of death further elevated among females. Although female inmates have higher rates of opioid use disorder and post-release overdose fatality, justice-involved women are under-represented in studies of medications for opioid use disorder. The Reducing Overdose After Release from Incarceration (ROAR) pilot intervention and evaluation (recruitment June 2019 through December 2020) aims to reduce opioid overdose among women released to the community following incarceration in state prison. The evaluation further assesses induction, acceptance and effectiveness of extended release naltrexone in a female post-prison population.Methods/designIn the week prior to their release, female adults in custody with moderate to severe opioid use disorder start treatment with extended release naltrexone, an injectable opioid antagonist that blocks the effects of opioids for up to 1 month. All ROAR participants receive training to use naloxone rescue kits and are provided nasal naloxone at release. Ongoing support from a certified recovery mentor to facilitate sustained engagement with treatment for substance use disorders begins in the month prior to release from prison and continues for 6 months in community. We evaluate the association between ROAR participation and the primary outcome of opioid overdose. Using administrative data provided by the Oregon Department of Corrections and the Oregon Health Authority, we compare the odds of overdose among ROAR participants versus a comparison group of females released from prison during the study period. Evaluation activities in community includes survey and qualitative interviews for 6 months post release, as well as a review of clinic records to assess retention on medication among the pilot cohort (N = 100).DiscussionROAR is a collaboration between Oregon's public health, criminal justice, and medical communities. The ROAR intervention and evaluation provide critical information on improving interventions to prevent opioid overdose and improve retention on treatment in community in an overlooked, high-risk population: incarcerated women re-entering the community.Trial registrationClinical Trials.gov TRN: NCT03902821 .

Project description:BackgroundNaloxone-based interventions as part of health systems can reverse an opioid overdose. Previous systematic reviews have identified the effectiveness of naloxone; however, the role of context and mechanisms for its use has not been explored. This realist systematic review aims to identify a theory of how naloxone works based on the contexts and mechanisms that contribute to the success of the intervention for improved outcomes.MethodsPre-registered at PROSPERO, this realist review followed RAMESES standards of reporting. Keywords included 'naloxone' and ' opioid overdose'. All study designs were included. Data extraction using 55 relevant outputs based on realist logic produced evidence of two middle-range theories: Naloxone Bystander Intervention Theory and Skills Transfer Theory.ResultsHarm reduction and/or low threshold contexts provide a non-judgemental approach which support in-group norms of helping and empower the social identity of the trained and untrained bystander. This context also creates the conditions necessary for skills transfer and diffusion of the intervention into social networks. Stigma and negative attitudes held by first responders and stakeholders involved in the implementation process, such as police or GPs, can prohibit the bystander response by inducing fear in responding. This interferes with skills transfer, naloxone use and carriage of naloxone kits.ConclusionsThe findings provide theoretically informed guidance regarding the harm reduction contexts that are essential for the successful implementation of naloxone-based interventions. Peer-to-peer models of training are helpful as it reinforces social identity and successful skills transfer between bystanders. Health systems may want to assess the prevalence of, and take steps to reduce opioid-related stigma with key stakeholders in contexts using a low threshold training approach to build an environment to support positive naloxone outcomes.Trial registrationPROSPERO 2019 CRD42019141003.

Dataset Information

Randomized controlled pilot trial of naloxone-on-release to prevent post-prison opioid overdose deaths.

Background and aims

Design

Setting

Participants

Intervention

Measurements

Findings

Conclusions

Publications

Randomized controlled pilot trial of naloxone-on-release to prevent post-prison opioid overdose deaths.

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