RELEVANCE: Methamphetamine (MA) is more prevalent than many other drugs, including opioids, with 37 million users of MA and amphetamine worldwide and 1.4 million past-year users in the U.S. alone in 2016. The number of MA poisoning deaths has steadily risen in recent years, from >3,700 in 2014 to 10,333 in 2017. Importantly, MA has been recognized as contributing substantially to the U.S. opioid crisis, with about half of MA poisoning deaths also caused by opioids. In the U.S., the annual economic cost of MA use is estimated to be $23.4 billion and use is strongly associated with HIV transmission. There are no FDA-approved pharmacologic treatments for MA use disorder, a major gap in addiction medicine, especially because behavioral interventions alone have limited efficacy and would likely benefit from adjunctive pharmacologic therapy.
DESCRIPTION: Previous randomized, placebo-controlled, double-blind trials have demonstrated a net reduction in MA positive urines in participants given mirtazapine. Before moving on to a larger trial, the FDA has requested additional data on the effects mirtazapine on those individuals using both MA and opioids. This drug-drug interaction (DDI) study will provide that data.
STATUS: This study is currently under regulatory review.