Nicotinic Modulation of Schizophrenia-like Information Processing Deficits in Healthy Subjects

Study Overview
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Brief Summary
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This study examines the interactive effects of ketamine and nicotine.

Official Title
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Nicotinic Modulation of (NMDA) Receptor Antagonist Schizophrenia-like Information Processing Deficits in Humans

Conditions
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Healthy Subjects

Intervention / Treatment
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* Drug: Ketamine
* Drug: Nicotine
* Drug: Placebo
* Drug: Ketamine and Nicotine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-50 years old Smokers

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ketamine and Nicotine<br>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 nicotine IV (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) | Drug: Ketamine and Nicotine<br>* 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)<br>|
| Placebo Comparator: Placebo Comparator<br>-Placebo administration: Normal saline (sodium chloride 0.9%)over 95 minutes | Drug: Placebo<br>* Normal saline (sodium chloride 0.9%)administered via IV (in the arm) over 95 minutes<br>|
| Active Comparator: Ketamine and Placebo<br>Ketamine administration: 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 Placebo administration: Normal saline (sodium chloride 0.9%)over 94 minutes | Drug: Ketamine<br>* 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<br>* Other names: Special K;|
| Active Comparator: Nicotine and Placebo<br>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) | Drug: Nicotine<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ketamine, nicotine, schizophrenia, cognitive deficits, P300 oddball paradigm, Mismatch Negativity, P50 gating