This pilot, double-blind, placebo-controlled randomized clinical trial (n=50) led by Brigham and Women’s Hospital aims to assess the safety and preliminary efficacy of ketamine (56mg/70kg) treatment for individuals with opioid use disorder (OUD) and suicidal ideation (SI) in the emergency department.
Participants will receive either a single infusion of ketamine (0.8mg/kg) or saline placebo. The study will evaluate the safety of ketamine treatment as the primary aim and determine its preliminary efficacy on opioid- and suicide-related outcomes as the secondary aim.
Eligible participants, English-speaking adults aged 18 and above diagnosed with DSM5 OUD with moderate or severe suicidal ideation, will be enrolled. Exclusion criteria include psychotic disorders, bipolar disorder, and active homicidal tendencies. Safety assessments will be conducted during and after the ketamine or placebo infusion, with follow-up assessments after discharge from the ED. The study is expected to begin in March 2024 and complete in May 2025.
Trial Details
This is a pilot, double-blind, placebo-controlled randomized clinical trial of individuals with opioid use disorder (OUD) with suicidal ideation in the emergency department (ED) to receive either a single infusion of ketamine 0.8mg/kg (n=25) or saline placebo (n=25). The primary aim is to evaluate the safety of the ketamine treatment. The secondary aim is to determine the preliminary efficacy of opioid- and suicide-related outcomes.NCT Number NCT06111339