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

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ClinicalTrials.gov Identifier: NCT00690170
Recruitment Status : Completed
First Posted : June 4, 2008
Last Update Posted : May 9, 2012
Sponsor:
Information provided by (Responsible Party):
Deepak C. D'Souza, Yale University

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

Condition or disease Intervention/treatment Phase
Healthy Subjects Drug: Ketamine Drug: Nicotine Drug: Placebo Drug: Ketamine and Nicotine Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Official Title: Nicotinic Modulation of (NMDA) Receptor Antagonist Schizophrenia-like Information Processing Deficits in Humans
Study Start Date : December 2002
Primary Completion Date : June 2009
Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Ketamine
U.S. FDA Resources

Arm Intervention/treatment
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)
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)

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

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
Other Names:
  • K
  • Special K
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)
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)



Primary Outcome Measures :
  1. 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 ]
  2. IntegNeuro is a computerized battery that consists of an automated stimulus presentation to measure cognitive function. [ Time Frame: +25 ]
  3. Positive and Negative Syndrome Scale will be used to measure psychotic symptoms. [ Time Frame: -90, +10, +105, +180 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18-50 years old
  • Smokers

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00690170


Locations
United States, Connecticut
Veterans Administration Hospital
West Haven, Connecticut, United States, 06516
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Deepak C D'Souza, M.D. Yale University School of Medicine Department of Psychiatry

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Deepak C. D'Souza, Associate Professor, Yale University
ClinicalTrials.gov Identifier: NCT00690170     History of Changes
Other Study ID Numbers: 18014
First Posted: June 4, 2008    Key Record Dates
Last Update Posted: May 9, 2012
Last Verified: May 2012

Keywords provided by Deepak C. D'Souza, Yale University:
ketamine
nicotine
schizophrenia
cognitive deficits
P300 oddball paradigm
Mismatch Negativity
P50 gating

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Nicotine
Ketamine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents