Challenges of enrolling participants with alcohol and opioid use disorders in the emergency department for clinical trials of ketamine: The experience from two randomized controlled trials.

Conducting double-blind placebo-controlled trials of ketamine for alcohol and opioid use disorders in the emergency department is extremely difficult. Over the study period, 180 individuals with alcohol use disorder were screened but none were eligible to enroll. Of 234 emergency department visits for opioid use disorder, only 8 were eligible, 4 consented, and all 4 were randomized and treated with ketamine or placebo, but none completed follow-up. The findings reinforce the need for innovative strategies to conduct such trials in this population.

Study at a glance

Abstract

Application of psychedelics including ketamine may be important adjuncts in the treatment of alcohol and opioid use disorders. Most patients with alcohol or opioid use disorder (AUD/OUD) may present to the emergency department (ED) seeking care both for substance use and associated complaints. Understanding safety and preliminary efficacy of ketamine and other psychedelics to improve the care and potentially facilitate linkage to long term care for AUD/OUD in the ED is of high importance. Here, we describe our experience conducting rigorous double blind placebo controlled trials to evaluate safety of ketamine in the ED for AUD/OUD and the challenges in conducting this research among this important population. We conducted two studies to evaluate the safety of a single dose ketamine infusion for individuals seeking detox with AUD and those seeking psychiatric care who had OUD. Studies were conducted at an urban community and academic ED with variable pharmacy capabilities. Over the study period study 1 (AUD) screened N = 180 individuals for the study of which N = 3 were preliminarily eligible. None were able to pass full eligibility criteria resulting in no enrollments. Study 2 (OUD) screened N = 234 ED visits were screen of which N = 8 were eligible and N = 4 consented. All four participants were successfully randomized and treated with ketamine or placebo. We were unable to conduct follow up in any of the participants. Enrollment of ED patients with AUD/OUD for ketamine trials in the ED is difficult and fraught with multiple challenges. Even with enrollment in the ED, follow up can be a significant challenge. This reinforces the need to consider innovative strategies to conduct ketamine and other psychedelic related trials among ED patients with AUD/OUD.