To explore whether intravenous ketamine followed by buprenorphine produces more rapid and sustained anti-suicidal effects than ketamine followed by placebo, investigators will conduct a single study that will take approximately 2.5 years to complete. 60 subjects (60 infusions) or approximately 24 infusions per year.
Topic Depression
Suicidality
Country United States of America
Visit trial
Status
Recruiting
Results Published
Start date
01 August 2020
End date
01 December 2022
Phase
Phase III
Design
Blinded
Type
Interventional
Generation
First
Participants
60
Sex
All
Age
18- 70
Therapy
No
Trial Details
The investigators hypothesize that patients who receive buprenorphine following ketamine will demonstrate significantly greater anti-suicidal effects beginning at day 7 and maintained for the entire four weeks of the study as well as longer times to recurrence than will those who receive ketamine followed by placebo. As secondary analyses, the investigators will test whether there is a relationship of improvement in sleep and pain to change in suicide ratings. Aim 2: To assess the potential role played by the opioid properties of a single infusion of ketamine, investigators will for the ketamine portion determine ketamine and metabolite blood levels during and after the infusion as well as pupillary changes and correlate them to anti-suicidal response at Day 1. Investigators will also collect blood to determine buprenorphine blood levels, prolactin as well as collecting data on pupillary changes and then assess for potential relationships with anti-suicidal response.Trial Number NCT04116528
Sponsors & Collaborators
Stanford UniversityResearchers at Stanford are exploring the potential of ketamine, MDMA and psilocybin by connecting neuroscience, psychiatry and anesthesiology.