Nicotine DependenceNCT00254358
A Brain Imaging Study of Nicotine Release in Cigarette Smokers
An observational study of Nicotine Dependence, run by Hadassah Medical Organization.
Trial summary
Tobacco Smoking is the most prevalent addiction in society today causing directly major health hazards and sharing morbidity with other psychiatric disorders. Nicotine binds to acetylcholine receptors and thus elevates DA release and inhibits DA transport. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Nicotine Dependence
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2007to Apr 2007
- 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: smokers in treatment with bupropion
Who may be able to join
- Chronic smokers and healthy non-smokers.
Who cannot join
- Pregnant and breast feeding women.
- Age below 20.
- Neurological disorders.
- Others drugs.
About this study
Tobacco Smoking is the most prevalent addiction in society today causing directly major health hazards and sharing morbidity with other psychiatric disorders. Nicotine binds to acetylcholine receptors and thus elevates DA release and inhibits DA transport. There are few studies using advanced brain imaging techniques to investigate how nicotine releases dopamine in humans. These studies utilized dopamine displacement paradigms with [11C] Raclopride binding to D2 receptor in Positron Emission Tomography (PET). There is evidence that smokers (particularly those who enjoyed smoking) showed decreased [11C] Raclopride binding in the caudate/nucleus accumbens and putamen after smoking cigarettes. These results also indicated that the effects of nicotine on dopaminergic neurotransmission are mediated by pleasure and craving. We propose to investigate the effects of smoking a cigarette ad lib on dopamine release by using dopamine competition paradigm with [I123] IBZM in SPECT. Secondly, we will test the hypothesis that dopamine deficiency is a major vulnerability factor for smoking. This may provide further evidence that dopamine deficiency in some smokers pre-disposes them to enjoy and desire smoking cigarettes more than others.
- Conditions
- Nicotine Dependence
- Keywords
- Nicotine, Dopamine, IBZM
- Medical subject headings
- Tobacco Use Disorder
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2005 (estimated)
- Study startApr 2007
- Study completionApr 2007
Why it stopped: It was decided to use a different protocol with a different radioligand
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nicotine DependenceStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Collaborators
- Herzog Hospital
- Investigators
- Yodphat Krausz, MD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00254358
- Sponsor's protocol ID
- 842902-HMO-CTIL
- Status last verified
- Jun 2008
- First submitted
- 15 Nov 2005
- Last updated
- 4 Jul 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Brain Imaging Study of Nicotine Release in Cigarette Smokers
- ClinicalTrials.gov ID
- NCT00254358
- Acronym / sponsor ID
- 842902-HMO-CTIL
- Conditions
- Nicotine Dependence
- Keywords
- Nicotine, Dopamine, IBZM
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: It was decided to use a different protocol with a different radioligand
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Collaborators
- Herzog Hospital
- Study start
- Apr 2007
- Study completion
- Apr 2007 (actual)
- First posted
- 16 Nov 2005 (estimated)
- 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.
Tobacco Smoking is the most prevalent addiction in society today causing directly major health hazards and sharing morbidity with other psychiatric disorders. Nicotine binds to acetylcholine receptors and thus elevates DA release and inhibits DA transport. There are few studies using advanced brain imaging techniques to investigate how nicotine releases dopamine in humans. These studies utilized dopamine displacement paradigms with [11C] Raclopride binding to D2 receptor in Positron Emission Tomography (PET). There is evidence that smokers (particularly those who enjoyed smoking) showed decreased [11C] Raclopride binding in the caudate/nucleus accumbens and putamen after smoking cigarettes. These results also indicated that the effects of nicotine on dopaminergic neurotransmission are mediated by pleasure and craving. We propose to investigate the effects of smoking a cigarette ad lib on dopamine release by using dopamine competition paradigm with [I123] IBZM in SPECT. Secondly, we will test the hypothesis that dopamine deficiency is a major vulnerability factor for smoking. This may provide further evidence that dopamine deficiency in some smokers pre-disposes them to enjoy and desire smoking cigarettes more than others.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- smokers in treatment with bupropion
Key inclusion criteria (1 listed)
- Chronic smokers and healthy non-smokers.
Key exclusion criteria (4 listed)
- Pregnant and breast feeding women.
- Age below 20.
- Neurological disorders.
- Others drugs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: It was decided to use a different protocol with a different radioligand). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2008.
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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.
Yodphat Krausz, MD principal investigator
Hadassah Medical Organization
Questions about this trial
What is this clinical trial studying?
An observational study of Nicotine Dependence, run by Hadassah Medical Organization.
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 1 inclusion and 4 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: stopped early, as of the sponsor's last update on 4 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
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 was stopped early (reason given: It was decided to use a different protocol with a different radioligand). Results are not available in the source record.
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.
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 4 Jul 2008.