Effect of Ketamine on Laboratory-induced Stress in Healthy Subjects
Condition: Healthy Volunteers
Intervention: Ketamine; Midazolam
Intervention description: administered 1 week prior to a laboratory-induced stress; administered 1 week prior to a laboratory-induced stress
Intervention MeSH terms: Midazolam; Ketamine
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants are assigned to one of two groups in parallel during the duration of the study: the ketamine arm or the midazolam arm.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Midazolam has similar acute anesthetic effects compared to ketamine. This makes midazolam an appropriate substance to gauge whether ketamine can affect stress response thereby acting as an active control.
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Ketamine; Resilience; Stress; Healthy Volunteers

Summary:

      The objective of this study is to examine the effect of a single IV dose of ketamine (0.5
      mg/kg) on laboratory-induced stress in healthy participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females aged 18-45 years;

          -  Does not meet for any current or past psychiatric diagnoses as defined by DSM-V
             criteria;

          -  Participants must have a level of understanding of the English language sufficient to
             agree to all tests and examinations required by the study and must be able to
             participate fully in the informed consent process.

        Exclusion Criteria:

          -  Any current or lifetime psychiatric disorder as determined by the Structured Clinical
             Interview for DSM-V Axis Disorders (SCID-5);

          -  Concomitant use of any medication with central nervous system activity, including
             treatment with antidepressants (classified as SSRIs, SNRIs, Atypical Antidepressants,
             TCAs);

          -  Any unstable medical illnesses including hepatic, renal impairment, gastroenterologic
             (including gastro-esophageal reflux disease), respiratory (including obstructive sleep
             apnea, or history of difficulty with airway management during previous anesthetics),
             cardiovascular (including ischemic heart disease and uncontrolled hypertension),
             endocrinologic, neurologic (including history of severe head injury), immunologic, or
             hematologic disease;

          -  Hypertension (systolic BP >160 mm Hg or diastolic BP >90 mm Hg) at screening or
             immediately prior to treatment with ketamine/midazolam;

          -  Clinically significant abnormal findings of laboratory parameters, physical
             examination, or ECG; clinically significant is defined by an abnormality that suggests
             a disease and/or organ toxicity that is new or has worsened from screening, or if the
             abnormality is of a degree that requires additional active management (e.g., further
             diagnostic investigation).

          -  Patients who have a positive urine toxicology test for illicit substances at screening
             and on the treatment day.

          -  Previous recreational use of PCP or ketamine.

          -  Subjects who have received ketamine in the past.