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Research Questions

  1. What does the high-quality scientific evidence suggest regarding the effectiveness of HAT and SCSs?
  2. What are the legal considerations surrounding potential introduction of HAT and SCSs in the United States?
  3. What are the policy, technical, and community issues surrounding potential introduction of HAT and SCSs in the United States, particularly in areas hard hit by the opioid crisis?

Current levels of opioid-related morbidity and mortality in the United States are staggering. Data for 2017 indicate that there were more than 47,000 opioid-involved overdose deaths, and one in eight adults now reports having had a family member or close friend die from opioids. Increasing the availability and reducing the costs of approved medications for those with an opioid use disorder (OUD) is imperative; however, jurisdictions addressing OUDs and overdose may wish to consider additional interventions. Two interventions that are implemented in some other countries but not in the United States are heroin-assisted treatment (HAT; sometimes referred to as supervised injectable heroin treatment) and supervised consumption sites (SCSs; sometimes referred to as overdose prevention sites). Given the severity of the opioid crisis, there is urgency to evaluate tools that might reduce its impact and save lives. In this mixed-methods report, the authors assess evidence on and arguments made about HAT and SCSs and examine some of the issues associated with implementing them in the United States.

Key Findings

  • Evidence from randomized controlled trials of HAT in Canada and Europe indicates that supervised injectable HAT — with optional oral methadone — can offer benefits over oral methadone alone for treating OUD among individuals who have tried traditional treatment modalities, including methadone, multiple times but are still injecting heroin.
  • Although heroin cannot be prescribed in the United States because it is a Schedule I drug, it would be legal to conduct a human research trial on HAT.
  • The literature on treating OUD with hydromorphone (e.g., Dilaudid) is less extensive than the literature on HAT; however, the existing results are encouraging. Hydromorphone trials in the United States would face fewer barriers than HAT trials.
  • The scientific evidence about the effectiveness of SCSs is limited in quality and the number of locations evaluated.
  • Many SCSs have been around for 15 to 30 years. Persistence does not imply effectiveness, but it seems unlikely that these SCSs — which were initially controversial in many places — would have such longevity if they had serious adverse consequences for their clients or communities.
  • For drug consumption that is supervised, SCSs reduce the risk of a fatal overdose, disease transmission, and harms associated with unhygienic drug use practices; however, there is uncertainty about the size of the population-level effects of SCSs.
  • There are significant legal issues surrounding the implementation of SCSs in the United States..
  • Both HAT and SCSs, as currently implemented, serve only a small share of people who use heroin. It is important to have a sense of potential scale limitations and costs when discussing HAT and SCSs.
  • It might be constructive to view HAT and SCSs as exemplars of broader strategies, not as the only option within their class.

Recommendations

  • Given (1) the increased mortality associated with fentanyl, (2) the fact that some people who use heroin may not respond well to existing medications for OUD, (3) HAT's successful implementation abroad, and (4) questions concerning whether the success would carry over to the United States, HAT trials should be conducted in some of the U.S. jurisdictions that already provide a spectrum of social services and good accessibility to medication treatments for OUD.
  • Conducting trials with HAT and hydromorphone are not mutually exclusive, and it may make sense to include both in the same study, as was done in Canada. Assessing the impact of injectable hydromorphone via clinical trials (with or without a HAT arm) would inform future regulatory decisions about using it as a medication treatment for OUD.
  • Some researchers and advocates believe that, during an emergency like the present opioid crisis, the absence of a large downside risk for an intervention that has strong face validity (e.g., SCSs) may be sufficient for some decisionmakers to proceed, rather than waiting for further evidence. Nevertheless, if attempts to implement SCSs in the United States are successful, a strong research component should be incorporated into these efforts.

Table of Contents

  • Chapter One

    Introduction

  • Chapter Two

    Research Approach

  • Chapter Three

    Heroin-Assisted Treatment

  • Chapter Four

    Supervised Consumption Sites

  • Chapter Five

    Ideas for Informing Future Research and Policy Discussions

  • Appendix

    A Brief History of Heroin-Assisted Treatment Discussions in the United States

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