Investigation of Brain Oxygenation and Blood Flow in Smokers
NCT ID: NCT03571243
Last Updated: 2019-07-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
30 participants
OBSERVATIONAL
2018-04-30
2019-06-30
Brief Summary
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Detailed Description
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In this study, the oxygen extraction fraction (OEF), the cerebral blood flow (CBF) and the cerebral metabolic rate of oxygen (CMRO2) are to be measured in smokers and non-smokers using MRI. On the one hand, the influence of chronic smoking (i.e. smokers versus non-smokers) and on the other hand the effect of acute nicotine administration (in smokers) on these parameters will be examined. Furthermore, the influence of these parameters on fMRI results is to be investigated using the example of a stimulus-reaction task. It can be assumed that the OEF does not change through nicotine administration, but differs in smokers and non-smokers and is associated with the strength of tobacco addiction in smokers. CBF and CMRO2 are expected to be reduced in abstinent smokers, but can be normalized by nicotine administration. In this study, 20 smokers and 10 never-smokers will be investigated. Never-smokers will be examined once with MRI and questionnaires, whereas smokers will be examined twice: before and after a smoking break.
Conditions
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Study Design
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CASE_ONLY
CROSS_SECTIONAL
Study Groups
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smokers
no intervention
no intervention
observational study
never-smokers
no intervention
no intervention
observational study
Interventions
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no intervention
observational study
Eligibility Criteria
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Inclusion Criteria
* right-handed
* normal or correctable eyesight
* Sufficient ability to communicate with the investigators, to answer questions in oral and written form
* "Fully Informed Consent"
* "Written Informed Consent"
* Group 1 - Smokers: Occasional smoker or tobacco consumption disorder according to DSM 5
* Group 2 - Never-Smokers: Consumption of less than 20 cigarettes in life
Exclusion Criteria
* Withdrawal of the declaration of consent
* severe internal, neurological and psychiatric comorbidities
* Pharmacotherapy with psychoactive substances within the last 14 days
* Current substance abuse
* Axis 1 disorder according to ICD-10 and DSM 5 (except tobacco use disorder and specific phobia within the last 12 months)
18 Years
65 Years
ALL
Yes
Sponsors
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Central Institute of Mental Health, Mannheim
OTHER
Responsible Party
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Principal Investigators
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Sabine Vollstädt-Klein
Role: PRINCIPAL_INVESTIGATOR
ZI Mannheim
Locations
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Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit
Mannheim, , Germany
Countries
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Other Identifiers
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44
Identifier Type: -
Identifier Source: org_study_id
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