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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Deepak C. D'Souza, Yale University
ClinicalTrials.gov Identifier:
NCT00690170
First received: May 30, 2008
Last updated: May 8, 2012
Last verified: May 2012
  Purpose

This study examines the interactive effects of ketamine and nicotine.


Condition Intervention Phase
Healthy Subjects
Drug: Ketamine
Drug: Nicotine
Drug: Placebo
Drug: Ketamine and Nicotine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Basic Science
Official Title: Nicotinic Modulation of (NMDA) Receptor Antagonist Schizophrenia-like Information Processing Deficits in Humans

Resource links provided by NLM:


Further study details as provided by Yale University:

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

Enrollment: 30
Study Start Date: December 2002
Study Completion Date: September 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18-50 years old
  • Smokers
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by Yale University

Additional 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
Study First Received: May 30, 2008
Last Updated: May 8, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Yale University:
ketamine
nicotine
schizophrenia
cognitive deficits
P300 oddball paradigm
Mismatch Negativity
P50 gating

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

ClinicalTrials.gov processed this record on October 21, 2014