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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

Tracking Information
First Submitted Date  ICMJE May 30, 2008
First Posted Date  ICMJE June 4, 2008
Last Update Posted Date May 9, 2012
Study Start Date  ICMJE December 2002
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 30, 2008)
  • 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 ]
  • IntegNeuro is a computerized battery that consists of an automated stimulus presentation to measure cognitive function. [ Time Frame: +25 ]
  • Positive and Negative Syndrome Scale will be used to measure psychotic symptoms. [ Time Frame: -90, +10, +105, +180 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: May 30, 2008)
  • CADSS: scale that measures perceptual alterations. [ Time Frame: -90, +10, +105, +180 ]
  • Visual Analog Scale: a 5-item feeling state scale associated with ketamine. [ Time Frame: -90,+10, +105, +180 ]
  • Ketamine, nicotine and cotinine blood levels will be measured to rule out any pharmacokinetic interactions [ Time Frame: -60,+5(ketamine only), +20(nicotine and cotinine only), +65, +100,+180 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Nicotinic Modulation of Schizophrenia-like Information Processing Deficits in Healthy Subjects
Official Title  ICMJE Nicotinic Modulation of (NMDA) Receptor Antagonist Schizophrenia-like Information Processing Deficits in Humans
Brief Summary This study examines the interactive effects of ketamine and nicotine.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Healthy Subjects
Intervention  ICMJE
  • 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
  • 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)

Study Arms  ICMJE
  • 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)
    Intervention: Drug: Ketamine and Nicotine
  • Placebo Comparator: Placebo Comparator
    -Placebo administration: Normal saline (sodium chloride 0.9%)over 95 minutes
    Intervention: Drug: Placebo
  • 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

    Intervention: Drug: Ketamine
  • 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)
    Intervention: Drug: Nicotine
Publications * D'Souza DC, Ahn K, Bhakta S, Elander J, Singh N, Nadim H, Jatlow P, Suckow RF, Pittman B, Ranganathan M. Nicotine fails to attenuate ketamine-induced cognitive deficits and negative and positive symptoms in humans: implications for schizophrenia. Biol Psychiatry. 2012 Nov 1;72(9):785-94. doi: 10.1016/j.biopsych.2012.05.009. Epub 2012 Jun 19.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 30, 2008)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2009
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 18-50 years old
  • Smokers
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00690170
Other Study ID Numbers  ICMJE 18014
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Deepak C. D'Souza, Yale University
Study Sponsor  ICMJE Yale University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Deepak C D'Souza, M.D. Yale University School of Medicine Department of Psychiatry
PRS Account Yale University
Verification Date May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP