Investigation of Brain Oxygenation and Blood Flow in Smokers

Cerebral Oxygenation and Blood Flow in Tobacco Use Disorder Clinical Trial

— OEF  

Official title:

Investigation of Oxygenation and Blood Flow in the Brain of Smokers and Their Relation to Smoking Abstinence.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03571243
• Other study ID #: 44
• Status: Completed
• Start date: April 30, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: July 2019
• Source: Central Institute of Mental Health, Mannheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cerebral Oxygenation and Blood Flow in Tobacco Use Disorder
• Tobacco Use Disorder

Intervention

Other:
• no intervention
observational study

Locations

Country	Name	City	State
Germany	Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit	Mannheim

Sponsors (1)

Lead Sponsor	Collaborator
Central Institute of Mental Health, Mannheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MRI data	oxygenation, blood flow and fMRI data; in smokers pre and post smoking; in never-smokers one session	MRI measurement at one day