Healthy Subjects
Conditions
Keywords
ketamine, nicotine, schizophrenia, cognitive deficits, P300 oddball paradigm, Mismatch Negativity, P50 gating
Brief summary
This study examines the interactive effects of ketamine and nicotine.
Interventions
DRUGKetamine
Ketamine: 0.23 mg/kg bolus over one minute followed by maintenance infusion at 0.58mg/kg/hour x 30 minutes, followed by 0.29 mg/kg/hour x 64 minutes
DRUGNicotine
Nicotine: 13.5 µg/kg given over 10 min (1.35 µg/min/kg),IV (in the arm) followed by a constant infusion of 31.02 µg/kg given over 85 min (0.365 µg/min/kg) Placebo: Normal saline (sodium chloride 0.9%)IV (in the arm)
DRUGPlacebo
Normal saline (sodium chloride 0.9%)administered via IV (in the arm) over 95 minutes
DRUGKetamine and Nicotine
0.23 mg/kg of ketamine bolus IV (in the arm) over one minute followed by maintenance infusion at 0.58mg/kg/hour x 30 minutes, followed by 0.29 mg/kg/hour x 64 minutes. 13.5 µg/kg of nicotineIV (in the arm) given over 10 min (1.35 µg/min/kg), followed by a constant infusion of 31.02 µg/kg given over 85 min (0.365 µg/min/kg)
Sponsors
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* 18-50 years old * Smokers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ERP recording procedures: Brain wave activity during tasks involving in processing auditory and visual stimuli with different degrees of attentional and memory demands will be recorded. | +65 |
| IntegNeuro is a computerized battery that consists of an automated stimulus presentation to measure cognitive function. | +25 |
| Positive and Negative Syndrome Scale will be used to measure psychotic symptoms. | -90, +10, +105, +180 |
Countries
United States
Outcome results
None listed