Completed

NCT Number: NCT03571243

Investigation of Brain Oxygenation and Blood Flow in Smokers

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

Completed

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Key information

Conditions

Cerebral Oxygenation and Blood Flow in Tobacco Use Disorder

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit

Mannheim, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

No intervention

Other

observational study

Primary outcomes

MRI data

Time frame: MRI measurement at one day

oxygenation, blood flow and fMRI data; in smokers pre and post smoking; in never-smokers one session

Sponsors and collaborators

Lead sponsor

Central Institute of Mental Health, Mannheim

Other

Registry information

Official study title

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

Acronym: OEF

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2019
First posted: Jun 27, 2018
Registry last updated: Jul 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.