Nicotine DependenceNCT00429208
Effect Of Nicotine on Neurocognitive Performance of Cigarette Smokers
A study testing Nicotine in people with Nicotine Dependence and Smoking, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
This research project addresses the hypothesis that a neurocognitive profile characterized by impairment of response inhibition and sustained attention may be a risk factor for smoking initiation and nicotine dependence among young women. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Nicotine Dependence, Smoking, Tobacco Use Disorder
- What is being tested?
- Nicotine
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2007to Apr 2007
- Phase
- Interventional
- 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 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Reported smoking cigarettes on a daily basis at the time of the original study and continue to smoke currently
- Manifested poor performance on the MFFT (The neurocognitive test that yielded differences between smokers and non-smokers)
- Competent and willing to give written informed consent
Who cannot join
- Pregnancy, breast-feeding, non-use of contraception such that the possibility of pregnancy cannot be excluded
- Intake of any medication that may potentially interact with nicotine.
- Any current or past medical condition that represents a contra-indication to nicotine administration.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hadassah Medical Organization
Jerusalem
Arik Tzukert, DMD, 00 972 2 6776095, arik@hadassah.org.il
Hadas Lemberg, PhD, 00 972 2 6777572, lhadas@hadassah.org.il
About this study
Official title: Effect Of Nicotine on Neurocognitive Performance of Cigarette Smokers: A Double-Blind, Within-Subjects, Placebo-Controlled Study
This research project addresses the hypothesis that a neurocognitive profile characterized by impairment of response inhibition and sustained attention may be a risk factor for smoking initiation and nicotine dependence among young women. Nicotine has short- term, facilitating effects on attention and response inhibition. Therefore, individuals who are impaired on cognitive functions such as these and initiate cigarette smoking may be more likely to maintain the habit and develop nicotine dependence. The research protocol specifically tests whether administration of nicotine to non-abstinent, regular cigarette smokers improves cognitive function in those domains where the participants had previously been shown to manifest performance deficits
- Being tested
- Nicotine
- Keywords
- Nicotine Dependence, Smoking, Tobacco Use Disorder, Nicotine Use Disorder
- Medical subject headings
- Tobacco Use Disorder, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NicotineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurocognitive functions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2007 (estimated)
- Study startFeb 2007
- Study completionApr 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- Avi Yakir, MD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00429208
- Sponsor's protocol ID
- yakir@hmo
- Status last verified
- Jan 2007
- First submitted
- 30 Jan 2007
- Last updated
- 31 Jan 2007
- Results posted
- No
Publications
Yakir A, Rigbi A, Kanyas K, Pollak Y, Kahana G, Karni O, Eitan R, Kertzman S, Lerer B. Why do young women smoke? III. Attention and impulsivity as neurocognitive predisposing factors. Eur Neuropsychopharmacol. 2007 Apr;17(5):339-51. doi: 10.1016/j.euroneuro.2006.09.004. Epub 2006 Nov 30.
PubMed 17141485
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Nicotine on Neurocognitive Performance of Cigarette Smokers: A Double-Blind, Within-Subjects, Placebo-Controlled Study
- ClinicalTrials.gov ID
- NCT00429208
- Acronym / sponsor ID
- yakir@hmo
- Keywords
- Nicotine Dependence, Smoking, Tobacco Use Disorder, Nicotine Use Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Feb 2007
- Study completion
- Apr 2007 (estimated)
- First posted
- 31 Jan 2007 (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.
This research project addresses the hypothesis that a neurocognitive profile characterized by impairment of response inhibition and sustained attention may be a risk factor for smoking initiation and nicotine dependence among young women. Nicotine has short- term, facilitating effects on attention and response inhibition. Therefore, individuals who are impaired on cognitive functions such as these and initiate cigarette smoking may be more likely to maintain the habit and develop nicotine dependence. The research protocol specifically tests whether administration of nicotine to non-abstinent, regular cigarette smokers improves cognitive function in those domains where the participants had previously been shown to manifest performance deficits
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Reported smoking cigarettes on a daily basis at the time of the original study and continue to smoke currently
- Manifested poor performance on the MFFT (The neurocognitive test that yielded differences between smokers and non-smokers)
- Competent and willing to give written informed consent
Key exclusion criteria (3 listed)
- Pregnancy, breast-feeding, non-use of contraception such that the possibility of pregnancy cannot be excluded
- Intake of any medication that may potentially interact with nicotine.
- Any current or past medical condition that represents a contra-indication to nicotine administration.
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 |
|---|---|---|
| Nicotine | Drug | – |
Primary outcome
Neurocognitive functions
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2007.
- Results publication: PubMed 17141485Yakir A, Rigbi A, Kanyas K, Pollak Y, Kahana G, Karni O, Eitan R, Kertzman S, Lerer B. Why do young women smoke? III. Attention and impulsivity as neurocognitive predisposing factors. Eur Neuropsychopharmacol. 2007 Apr;17(5):339-51. doi: 10.1016/j.euroneuro.2006.09.004. Epub 2006 Nov 30.
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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.
Avi Yakir, MD principal investigator
Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nicotine in people with Nicotine Dependence and Smoking, run by Hadassah Medical Organization at 1 site in Israel.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 31 Jan 2007. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Avi Yakir, MD (00 972 2 6777184, yakir@hadassah.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurocognitive functions. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00429208, which also lists 1 linked publication.
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 31 Jan 2007.