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

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

This study examines the interactive effects of ketamine and nicotine.

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 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 Comparator
  • -Placebo administration: Normal saline (sodium chloride 0.9%)over 95 minutes
• Active Comparator: Ketamine and Placebo
  • 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
• Active Comparator: Nicotine and Placebo
  • 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)

Primary Measures

• 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.
  • Time Frame: +65
    Safety Issue?: Yes
• IntegNeuro is a computerized battery that consists of an automated stimulus presentation to measure cognitive function.
  • Time Frame: +25
    Safety Issue?: Yes
• Positive and Negative Syndrome Scale will be used to measure psychotic symptoms.
  • Time Frame: -90, +10, +105, +180
    Safety Issue?: Yes

Inclusion Criteria:

• 18-50 years old
• Smokers

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 50 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: Yale University Other

Overall Clinical Trial Officials and Contacts

Deepak C D'Souza, M.D. Principal Investigator Yale University School of Medicine Department of Psychiatry  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00690170

Study ID Number: 18014

ClinicalTrials.gov Identifier: NCT00690170

Health Authority: United States: Food and Drug Administration