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Completed

NCT Number: NCT00690170

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

This study examines the interactive effects of ketamine and nicotine.

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Key information

Conditions

Healthy Subjects Cognition Disorders Mental Disorders Neurocognitive Disorders Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Veterans Administration Hospital

West Haven, Connecticut, 06516, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18-50 years old
  • Smokers

Treatment and study plan

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

Other names: K, Special K

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)

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Official study title

Nicotinic Modulation of (NMDA) Receptor Antagonist Schizophrenia-like Information Processing Deficits in Humans

Important dates

Study start
2002
Primary completion
2009
Study completion
2009
First posted
Jun 4, 2008
Registry last updated
May 9, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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