NCT00690170

Brief Summary

This study examines the interactive effects of ketamine and nicotine.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2002

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2002

Completed
5.5 years until next milestone

First Submitted

Initial submission to the registry

May 30, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 4, 2008

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

May 9, 2012

Status Verified

May 1, 2012

Enrollment Period

6.5 years

First QC Date

May 30, 2008

Last Update Submit

May 8, 2012

Conditions

Healthy Subjects

Keywords

ketaminenicotineschizophreniacognitive deficitsP300 oddball paradigmMismatch NegativityP50 gating

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (4)

Ketamine and Nicotine

ACTIVE COMPARATOR

* 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

Placebo Comparator

PLACEBO COMPARATOR

-Placebo administration: Normal saline (sodium chloride 0.9%)over 95 minutes

Drug: Placebo

Ketamine and Placebo

ACTIVE COMPARATOR

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

Nicotine and Placebo

ACTIVE COMPARATOR

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

Interventions

KetamineDRUG

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

Also known as: K, Special K
Ketamine and Placebo
NicotineDRUG

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)

Nicotine and Placebo
PlaceboDRUG

Normal saline (sodium chloride 0.9%)administered via IV (in the arm) over 95 minutes

Placebo Comparator
Ketamine and NicotineDRUG

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)

Ketamine and Nicotine

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years old
  • Smokers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Veterans Administration Hospital

West Haven, Connecticut, 06516, United States

Location

Related Publications (1)

  • 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.

    PMID: 22717030DERIVED

MeSH Terms

Conditions

SchizophreniaCognition Disorders

Interventions

KetamineNicotine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersNeurocognitive Disorders

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsSolanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Deepak C D'Souza, M.D.

    Yale University School of Medicine, Department of Psychiatry

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 30, 2008

First Posted

June 4, 2008

Study Start

December 1, 2002

Primary Completion

June 1, 2009

Study Completion

September 1, 2009

Last Updated

May 9, 2012

Record last verified: 2012-05

Locations

US(1)