Tobacco Use DisorderPhase 1/2NIKOGENNCT00618280
Social Cognition,Attentional Network and Nicotine Drug Dependency - A Pharmacological Clinical Trail
A Phase 1/2 study testing nicotine nasal spray in people with Tobacco Use Disorder and Schizophrenia, run by Heinrich-Heine University, Duesseldorf at 2 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use Disorder, Schizophrenia
- What is being tested?
- nicotine nasal spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 101 participants
- Where
- 2 sitesGermany
- Study dates
- Jan 2008to Aug 2010
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- known hypersensitivity towards nicotine or any substance of placebo preparation
- adenoids
- Rhinitis vaso.
- hypersensitivity of air passages
- cardiovascular diseases (defined)
- neurological diseases (defined)
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- diabetes mellitus
- hyperthyreosis
- phaeochromocytoma
- Clozapine (schizophrenic)
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Psychiatrische Klinik und Poliklinik der Heinrich-Heine-Universität
Düsseldorf, North Rhine-Westphalia, 40629
Forschungszentrum Jülich GmbH
Jülich, North Rhine-Westphalia, 52425
About this study
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.
Read the detailed description
Nicotine is improving attentional capacity which goes along with an activation of the attentional network in the brain. So far, however, it is unresolved whether nicotine is used for the purpose of self-medication by those nicotine-dependent subjects who suffer from subclinical or clinical attentional deficits which may sustain nicotine addiction. 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. It is anticipated that low attentional network activity (during baseline condition, after nicotine challenge and after withdrawal) predicts the degree of nicotine dependence including the strength of withdrawal symptoms and relapse rate after smoking cessation. In addition, we expect that functional variations within alpha4beta2 nAch receptor genotype are associated with attentional capacity and -by extension - with nicotine dependence.
Additionally Self-medication of attentional deficits and of increased stress vulnerability may contribute to nicotine-dependence both in schizophrenia patients and healthy subjects. However, very little is known about the effect of nicotine on stress in schizophrenia. In particular social stressors are highly relevant in schizophrenia often resulting in social withdrawal. A factor contributing to the stress-eliciting nature of social interaction is the misidentification of social information during communication with others. The present project aims at an investigation of nicotine effects on such social information processing and its neurophysiological correlates and on social stress responses. Using a 2x2-factorial design effects of nicotine vs. placebo are experimentally investigated in smoking schizophrenia patients in comparison to smoking healthy controls each after an overnight smoking deprivation. Nicotine will be administered by nasal spray delivering a systemic does of 2 mg nicotine. Event-related EEG potentials will be recorded during the presentation of pictures of facial affect and neutral control stimuli to assess social information processing and its neurophysiological correlates. In addition a videotaped semi-standardized conversation skills role-play test will be used as a social stress situation to assess self-reported and non-verbal affective responses.
- Conditions
- Tobacco Use Disorder, Schizophrenia
- Being tested
- nicotine nasal spray
- Medical subject headings
- Tobacco Use Disorder, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nicotine nasal sprayDrug
Also called nicorette nasal spray
0,5 mg nicotine nasal spray or placebo (pepperspray)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: nicotine nasal spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of nicotine or placebo in healthy subjects and schizophrenic patients on attentional network activity in brain with functional magnetic resonance imaging and EEG
Measured: 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
Measured: after last subject out
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionJun 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
- More trials run by Heinrich-Heine University, DuesseldorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Collaborators
- German Research Foundation
- Responsible party
- Sponsor
- Investigators
- G. Winterer, Prof. Dr., Principal investigator, Department of Psychiatry and Psychotherapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00618280
- Sponsor's protocol ID
- NIKOGEN_HHU_2006
- Acronym
- NIKOGEN
- Status last verified
- Mar 2012
- First submitted
- 8 Feb 2008
- Last updated
- 2 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22452559Luckhaus 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.
PubMed 22160487
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Cognition,Attentional Network and Nicotine Drug Dependency - A Pharmacological Clinical Trail
- ClinicalTrials.gov ID
- NCT00618280
- Acronym / sponsor ID
- NIKOGEN / NIKOGEN_HHU_2006
- Conditions
- Tobacco Use Disorder, Schizophrenia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Collaborators
- German Research Foundation
- Study start
- Jan 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 20 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Nicotine is improving attentional capacity which goes along with an activation of the attentional network in the brain. So far, however, it is unresolved whether nicotine is used for the purpose of self-medication by those nicotine-dependent subjects who suffer from subclinical or clinical attentional deficits which may sustain nicotine addiction. 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. It is anticipated that low attentional network activity (during baseline condition, after nicotine challenge and after withdrawal) predicts the degree of nicotine dependence including the strength of withdrawal symptoms and relapse rate after smoking cessation. In addition, we expect that functional variations within alpha4beta2 nAch receptor genotype are associated with attentional capacity and -by extension - with nicotine dependence.
Additionally Self-medication of attentional deficits and of increased stress vulnerability may contribute to nicotine-dependence both in schizophrenia patients and healthy subjects. However, very little is known about the effect of nicotine on stress in schizophrenia. In particular social stressors are highly relevant in schizophrenia often resulting in social withdrawal. A factor contributing to the stress-eliciting nature of social interaction is the misidentification of social information during communication with others. The present project aims at an investigation of nicotine effects on such social information processing and its neurophysiological correlates and on social stress responses. Using a 2x2-factorial design effects of nicotine vs. placebo are experimentally investigated in smoking schizophrenia patients in comparison to smoking healthy controls each after an overnight smoking deprivation. Nicotine will be administered by nasal spray delivering a systemic does of 2 mg nicotine. Event-related EEG potentials will be recorded during the presentation of pictures of facial affect and neutral control stimuli to assess social information processing and its neurophysiological correlates. In addition a videotaped semi-standardized conversation skills role-play test will be used as a social stress situation to assess self-reported and non-verbal affective responses.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: nicotine nasal sprayschizophrenic 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 |
| 2 | Placebo comparator | Drug: nicotine nasal sprayschizophrenic 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 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (10 listed)
- known hypersensitivity towards nicotine or any substance of placebo preparation
- adenoids
- Rhinitis vaso.
- hypersensitivity of air passages
- cardiovascular diseases (defined)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nicotine nasal sprayAlso: nicorette nasal spray0,5 mg nicotine nasal spray or placebo (pepperspray) | Drug | 1, 2 |
Primary outcome
Effect of nicotine or placebo in healthy subjects and schizophrenic patients on attentional network activity in brain with functional magnetic resonance imaging and EEG
Time frame: after last subject out
1 secondary outcome
-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
Time frame: after last subject out
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2012.
- Derived from this study: PubMed 22452559Warbrick 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.
- Derived from this study: PubMed 22160487Luckhaus 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
G. Winterer, Prof. Dr. principal investigator
Department of Psychiatry and Psychotherapy
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing nicotine nasal spray in people with Tobacco Use Disorder and Schizophrenia, run by Heinrich-Heine University, Duesseldorf at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of nicotine or placebo in healthy subjects and schizophrenic patients on attentional network activity in brain with functional magnetic resonance imaging and EEG (time frame: after last subject out). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00618280, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2012.