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

Primary Purpose

Healthy Subjects

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Ketamine
Nicotine
Placebo
Ketamine and Nicotine
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Healthy Subjects focused on measuring ketamine, nicotine, schizophrenia, cognitive deficits, P300 oddball paradigm, Mismatch Negativity, P50 gating

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 18-50 years old
  • Smokers

Sites / Locations

  • Veterans Administration Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Ketamine and Nicotine

Placebo Comparator

Ketamine and Placebo

Nicotine and Placebo

Arm Description

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)

Outcomes

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.
IntegNeuro is a computerized battery that consists of an automated stimulus presentation to measure cognitive function.
Positive and Negative Syndrome Scale will be used to measure psychotic symptoms.

Secondary Outcome Measures

Full Information

First Posted
May 30, 2008
Last Updated
May 8, 2012
Sponsor
Yale University
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1. Study Identification

Unique Protocol Identification Number
NCT00690170
Brief Title
Nicotinic Modulation of Schizophrenia-like Information Processing Deficits in Healthy Subjects
Official Title
Nicotinic Modulation of (NMDA) Receptor Antagonist Schizophrenia-like Information Processing Deficits in Humans
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
December 2002 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yale University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Subjects
Keywords
ketamine, nicotine, schizophrenia, cognitive deficits, P300 oddball paradigm, Mismatch Negativity, P50 gating

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ketamine and Nicotine
Arm Type
Active Comparator
Arm Description
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)
Arm Title
Placebo Comparator
Arm Type
Placebo Comparator
Arm Description
-Placebo administration: Normal saline (sodium chloride 0.9%)over 95 minutes
Arm Title
Ketamine and Placebo
Arm Type
Active Comparator
Arm Description
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
Arm Title
Nicotine and Placebo
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Ketamine
Other Intervention Name(s)
K, Special K
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Nicotine
Intervention Description
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 Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Normal saline (sodium chloride 0.9%)administered via IV (in the arm) over 95 minutes
Intervention Type
Drug
Intervention Name(s)
Ketamine and Nicotine
Intervention Description
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 Outcome Measure Information:
Title
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
Title
IntegNeuro is a computerized battery that consists of an automated stimulus presentation to measure cognitive function.
Time Frame
+25
Title
Positive and Negative Syndrome Scale will be used to measure psychotic symptoms.
Time Frame
-90, +10, +105, +180

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 18-50 years old Smokers
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deepak C D'Souza, M.D.
Organizational Affiliation
Yale University School of Medicine Department of Psychiatry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Veterans Administration Hospital
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06516
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22717030
Citation
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.
Results Reference
derived

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

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