NCT00618280

Brief Summary

In the present study, we investigate healthy subjects and schizophrenic patients who frequently show very low attentional capacity with functional magnetic resonance imaging (fMRI) and electrophysiology (EEG) during attention-requiring tasks to assess the level of attentional network activity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
101

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2008

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

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

January 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 8, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 20, 2008

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

March 2, 2012

Status Verified

March 1, 2012

Enrollment Period

2.4 years

First QC Date

February 8, 2008

Last Update Submit

March 1, 2012

Conditions

Tobacco Use DisorderSchizophrenia

Outcome Measures

Primary Outcomes (1)

  • Effect of nicotine or placebo in healthy subjects and schizophrenic patients on attentional network activity in brain with functional magnetic resonance imaging and EEG

    after last subject out

Secondary Outcomes (1)

  • -Effect of nicotine on a4b2 nAch receptor genotype -Gene Expression of a4b2 nAch -effect of 24 h nicotine withdrawal on modulation special hormones -effect of nicotine on neurophysiological correlates of social stress

    after last subject out

Study Arms (2)

1

ACTIVE COMPARATOR

schizophrenic and non schizophrenic patient stratified by smoking and non smoking will get nicotine and placebo on first day on the second day placebo and nicotine

Drug: nicotine nasal spray

2

PLACEBO COMPARATOR

schizophrenic and non schizophrenic patient stratified by smoking and non smoking will get nicotine and placebo on first day on the second day placebo and nicotine

Drug: nicotine nasal spray

Interventions

nicotine nasal sprayDRUG

0,5 mg nicotine nasal spray or placebo (pepperspray)

Also known as: nicorette nasal spray
12

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • age 18-55
  • informed consent
  • negative drug-screening (cannabis, amphetamine, opiate, cocaine)
  • no drug abuse in medical history for last 6 month
  • no participation of subjects in other pharmacological trials within 6 weeks
  • negative pregnancy test
  • use of effective contraception within participation of trial
  • normotonia (heart rate, RR)
  • nicotine dependence (Fagerström \>4)or not more than 20 cigarettes /lifetime
  • nicotine (smoker serum \> 2ng/mL)
  • DSM-IV criteria for schizophrenia
  • healthy subjects

You may not qualify if:

  • known hypersensitivity towards nicotine or any substance of placebo preparation
  • adenoids
  • Rhinitis vaso.
  • hypersensitivity of air passages
  • cardiovascular diseases (defined)
  • neurological diseases (defined)
  • diabetes mellitus
  • hyperthyreosis
  • phaeochromocytoma
  • Clozapine (schizophrenic)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Psychiatrische Klinik und Poliklinik der Heinrich-Heine-Universität

Düsseldorf, North Rhine-Westphalia, 40629, Germany

Location

Forschungszentrum Jülich GmbH

Jülich, North Rhine-Westphalia, 52425, Germany

Location

Related Publications (2)

  • Warbrick T, Mobascher A, Brinkmeyer J, Musso F, Stoecker T, Shah NJ, Fink GR, Winterer G. Nicotine effects on brain function during a visual oddball task: a comparison between conventional and EEG-informed fMRI analysis. J Cogn Neurosci. 2012 Aug;24(8):1682-94. doi: 10.1162/jocn_a_00236. Epub 2012 Mar 27.

    PMID: 22452559DERIVED

  • Luckhaus C, Henning U, Ferrea S, Musso F, Mobascher A, Winterer G. Nicotinic acetylcholine receptor expression on B-lymphoblasts of healthy versus schizophrenic subjects stratified for smoking: [3H]-nicotine binding is decreased in schizophrenia and correlates with negative symptoms. J Neural Transm (Vienna). 2012 May;119(5):587-95. doi: 10.1007/s00702-011-0743-1. Epub 2011 Dec 11.

    PMID: 22160487DERIVED

Related Links

MeSH Terms

Conditions

Tobacco Use DisorderSchizophrenia

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersSchizophrenia Spectrum and Other Psychotic Disorders

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • G. Winterer, Prof. Dr.

    Department of Psychiatry and Psychotherapy

    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
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2008

First Posted

February 20, 2008

Study Start

January 1, 2008

Primary Completion

June 1, 2010

Study Completion

August 1, 2010

Last Updated

March 2, 2012

Record last verified: 2012-03

Locations

DE(2)