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

Ketamine

Brief Summary

This study examines the interactive effects of ketamine and nicotine.

Intervention / Treatment

  • Ketamine (DRUG)
    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 (DRUG)
    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 (DRUG)
    Normal saline (sodium chloride 0.9%)administered via IV (in the arm) over 95 minutes
  • Ketamine and Nicotine (DRUG)
    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)

Condition or Disease

  • Healthy Subjects

Phase

  • Phase 1

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 18 Years to 50 Years
    Enrollment: 30 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Basic Science

    Masking

    TRIPLE:
    • Participant
    • Care Provider
    • Investigator

    Clinical Trial Dates

    Start date: Dec 01, 2002
    Primary Completion: Jun 01, 2009 ACTUAL
    Completion Date: Sep 01, 2009 ACTUAL
    Study First Posted: Jun 04, 2008 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: May 08, 2012

    Sponsors / Collaborators

    Lead Sponsor: Yale University
    Responsible Party: N/A

    Location

    West Haven, Connecticut, USA

    Participant Groups

    • * 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 administration: Normal saline (sodium chloride 0.9%)over 95 minutes

    • 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

    • 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 Criteria

    Sex: All
    Minimum Age: 18
    Maximum Age: 50
    Age Groups: Adult
    Healthy Volunteers: Yes

    Inclusion Criteria:

    * 18-50 years old
    * Smokers

    Primary Outcomes
    • 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
    • IntegNeuro is a computerized battery that consists of an automated stimulus presentation to measure cognitive function. +25
    • Positive and Negative Syndrome Scale will be used to measure psychotic symptoms. -90, +10, +105, +180

    More Details

    NCT Number: NCT00690170
    Other IDs: 18014
    Study URL: https://clinicaltrials.gov/study/NCT00690170
    Last updated: Sep 29, 2023