Cerebral Oxygenation and Blood Flow in Tobacco Use DisorderOEFNCT03571243
Investigation of Brain Oxygenation and Blood Flow in Smokers
An observational study of Cerebral Oxygenation and Blood Flow in Tobacco Use Disorder, run by Central Institute of Mental Health, Mannheim at 1 site in Germany.
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 Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Oxygenation and Blood Flow in Tobacco Use Disorder
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 30 Apr 2018to 30 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: residents from Mannheim/Heidelberg Germany and other.
Who may be able to join
- 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
Who cannot join
- women: pregnancy
- 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)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit
Mannheim
About this study
Official title: Investigation of Oxygenation and Blood Flow in the Brain of Smokers and Their Relation to Smoking Abstinence.
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
Read the 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.
- Being tested
- no intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
observational study
| Study group | Role | What they receive |
|---|---|---|
| smokers | no intervention Receives: Other: no intervention | |
| never-smokers | no intervention Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI data
oxygenation, blood flow and fMRI data; in smokers pre and post smoking; in never-smokers one session
Measured: MRI measurement at one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2018
- Study start30 Apr 2018
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Oxygenation and Blood Flow in Tobacco Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Institute of Mental Health, Mannheim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sabine Vollstädt-Klein, Principal investigator, ZI Mannheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03571243
- Sponsor's protocol ID
- 44
- Acronym
- OEF
- Status last verified
- Jul 2019
- First submitted
- 18 Jun 2018
- Last updated
- 5 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Oxygenation and Blood Flow in the Brain of Smokers and Their Relation to Smoking Abstinence.
- ClinicalTrials.gov ID
- NCT03571243
- Acronym / sponsor ID
- OEF / 44
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Central Institute of Mental Health, MannheimUniversity, hospital or other
- Study start
- 30 Apr 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 27 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| smokers | – | Other: no interventionno intervention |
| never-smokers | – | Other: no interventionno intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- residents from Mannheim/Heidelberg Germany and other.
Key inclusion criteria (8 listed)
- 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"
Key exclusion criteria (6 listed)
- women: pregnancy
- Withdrawal of the declaration of consent
- severe internal, neurological and psychiatric comorbidities
- Pharmacotherapy with psychoactive substances within the last 14 days
- Current substance abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionobservational study | Other | never-smokers, smokers |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sabine Vollstädt-Klein principal investigator
ZI Mannheim
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Oxygenation and Blood Flow in Tobacco Use Disorder, run by Central Institute of Mental Health, Mannheim at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRI data (time frame: MRI measurement at one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2019.