Ketamine for OUD and Suicidal Ideation in the ED

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.

Status Not yet recruiting
Results Published No
Start date 01 March 2024
End date 31 May 2025
Phase Phase II
Design Blinded
Type Interventional
Generation First
Participants 48
Sex All
Age 17- 99
Therapy No

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

Data attribution

A large set of the trials in our database are sourced from ClinicalTrials.gov (CTG). We have modified these post to display the information in a more clear format or to correct spelling mistakes. Our database in actively updated and may show a different status (e.g. completed) if we have knowledge of this update (e.g. a published paper on the study) which isn't reflected yet on CTG. If a trial is not sourced from CTG, this is indicated on this page and you can follow the link to the alternative source of information.