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

Phase 1

Completed

• Conditions: Healthy Subjects
• Interventions: Drug: Ketamine and Nicotine; Drug: Placebo; Drug: Nicotine; Drug: Ketamine

• Registration Number: NCT00690170
• Lead Sponsor: Yale University

Brief Summary

This study examines the interactive effects of ketamine and nicotine.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-12
• Study First Submitted: 2008-05-30
• Study First Submitted QC: 2008-05-30
• Study First Posted: 2008-06-04
• Primary Completion: 2009-06
• Study Completion: 2009-09
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-08
• Last Update Posted: 2012-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 18-50 years old
• Smokers

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Ketamine and Nicotine	Ketamine 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 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)
Placebo Comparator	Placebo	-Placebo administration: Normal saline (sodium chloride 0.9%)over 95 minutes
Nicotine and Placebo	Nicotine	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)
Ketamine and Placebo	Ketamine	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

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Veterans Administration Hospital; 🇺🇸 West Haven, Connecticut, United States