Clinical trial NCT03571243: Investigation of Brain Oxygenation and Blood Flow in Smokers
Official title: Investigation of Oxygenation and Blood Flow in the Brain of Smokers and Their Relation to Smoking Abstinence.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Oxygenation and Blood Flow in Tobacco Use Disorder
Lead sponsor: Central Institute of Mental Health, Mannheim
Sponsor class: OTHER
First posted: 2018-06-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: residents from Mannheim/Heidelberg Germany and other.

Brief summary: Cerebral oxygenation and blood flow in tobacco use disorder and their relation to smoking abstinence will be measured with MRI" ändern in "Cerebral oxygenation and blood flow in tobacco use disorder

Detailed description: In this study, cerebral oxygenation and tobacco-related attentional bias in smokers and non-smokers will be measured with magnetic resonance imaging (MRI).

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.

Eligibility criteria: Inclusion Criteria:

* age between 18 and 65
* 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:

* women: pregnancy
* Withdrawal of the declaration of consent
* Exclusion criteria for an MRI scan
* 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)

Primary outcomes:
measure: MRI data
timeFrame: MRI measurement at one day
Secondary outcomes:
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit
Study officials:
affiliation: ZI Mannheim
name: Sabine Vollstädt-Klein
role: PRINCIPAL_INVESTIGATOR
References: