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

Healthy Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00690170
• Other study ID #: 18014
• Status: Completed
• Phase: Phase 1
• First received: May 30, 2008
• Last updated: May 8, 2012
• Start date: December 2002
• Est. completion date: September 2009

Study information

• Verified date: May 2012
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study examines the interactive effects of ketamine and nicotine.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• 18-50 years old

• Smokers

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Subjects
• Schizophrenia

Intervention

Drug:
• Ketamine
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
• 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)
• Placebo
Normal saline (sodium chloride 0.9%)administered via IV (in the arm) over 95 minutes
• 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 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)

Locations

Country	Name	City	State
United States	Veterans Administration Hospital	West Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	IntegNeuro is a computerized battery that consists of an automated stimulus presentation to measure cognitive function.		+25	Yes
Primary	Positive and Negative Syndrome Scale will be used to measure psychotic symptoms.		-90, +10, +105, +180	Yes