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Clinical Trials/NCT03571243
NCT03571243CompletedNot Applicable

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

Central Institute of Mental Health, Mannheim1 site in 1 country30 target enrollmentStarted: April 30, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
30
Locations
1
Primary Endpoint
MRI data

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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)

Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Central Institute of Mental Health, Mannheim
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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