SmokingNCT01237834
Physiological Responses in Tobacco Chippers
An observational study of Smoking and Stress, run by Oregon Health and Science University at 1 site in United States.
Trial summary
This study will analyze a series of biological and behavioral markers in different populations of smokers. The study groups will differ in their cigarette consumption and level of nicotine dependence. This analysis will help to identify factors that might be important for smoking behavior and nicotine addiction. Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- How many people
- 178 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Jan 2013
- 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 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: General population
Who may be able to join
- healthy adults
- age 25-55
Who cannot join
- alcohol or drug addiction
- unstable significant medical problems
- neurologic disease
- medications known to affect CNS function or impact physiologic parameters measured in the study
- significant visual impairment
- breath carbon monoxide (BCO) level of less than 10 ppm for smokers
- breath carbon monoxide (BCO) level of more than 5 ppm for non-smokers
- for heavy regular smokers: erratic smoking history (i.e. they must have smoked an average of 15 cigarettes daily for at least one year)
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health and Science University
Portland, Oregon, 97239
About this study
Official title: Physiological Responses in Tobacco Chippers (Non Nicotine-dependent Light Smokers)
This study will analyze a series of biological and behavioral markers in different populations of smokers. The study groups will differ in their cigarette consumption and level of nicotine dependence. This analysis will help to identify factors that might be important for smoking behavior and nicotine addiction. The results from this study will contribute to improve campaigns for smoking prevention and treatments for smoking cessation.
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Heavy smokers, 15 or more cigarettes/day | Nicotine dependent. | |
| Light smokers (chippers) | Less than 2 cigarettes/day, at least 2 days/week. Non nicotine-dependent. | |
| Non smokers | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electroencephalography
Electroencephalography will be measured during performance on a hard cognitive task.
Measured: Changes from baseline during a hard cognitive task
Secondary outcomes (1)
Salivary cortisol
Salivary cortisol will be measured at baseline, during a hard cognitive task and 30 minutes after the cognitive task.
Measured: Changes from baseline during performance on a hard cognitive task
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies 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
- Time perspective
- Cross-sectional
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barry S. Oken, Oregon Health and Science University
- Investigators
- Barry Oken, Principal investigator, Oregon Health and Science UniversityLaura Carim Todd, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01237834
- Sponsor's protocol ID
- IRB6698
- Status last verified
- Oct 2014
- First submitted
- 9 Nov 2010
- Last updated
- 30 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological Responses in Tobacco Chippers (Non Nicotine-dependent Light Smokers)
- ClinicalTrials.gov ID
- NCT01237834
- Acronym / sponsor ID
- IRB6698
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 10 Nov 2010 (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 study will analyze a series of biological and behavioral markers in different populations of smokers. The study groups will differ in their cigarette consumption and level of nicotine dependence. This analysis will help to identify factors that might be important for smoking behavior and nicotine addiction. The results from this study will contribute to improve campaigns for smoking prevention and treatments for smoking cessation.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Heavy smokers, 15 or more cigarettes/day | – | –Nicotine dependent. |
| Light smokers (chippers) | – | –Less than 2 cigarettes/day, at least 2 days/week. Non nicotine-dependent. |
| Non smokers | – | – |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- General population
Key inclusion criteria (2 listed)
- healthy adults
- age 25-55
Key exclusion criteria (8 listed)
- alcohol or drug addiction
- unstable significant medical problems
- neurologic disease
- medications known to affect CNS function or impact physiologic parameters measured in the study
- significant visual impairment
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
Electroencephalography
Time frame: Changes from baseline during a hard cognitive task
Electroencephalography will be measured during performance on a hard cognitive task.
1 secondary outcome
Salivary cortisol
Time frame: Changes from baseline during performance on a hard cognitive task
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 30 Oct 2014.
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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.
Barry Oken principal investigator
Oregon Health and Science University
Laura Carim Todd principal investigator
Oregon Health and Science University
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 Smoking and Stress, run by Oregon Health and Science University at 1 site in United States.
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 2 inclusion and 8 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 30 Oct 2014. 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 United States. 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?
Electroencephalography (time frame: Changes from baseline during a hard cognitive task). 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 30 Oct 2014.