Cigarette SmokingPhase 16162-AAPK2NCT01058876
Comparison of Low Yield Cigarettes in African Americans vs. Whites
A Phase 1 study testing Deuterated nicotine and cotinine in people with Cigarette Smoking, run by University of California, San Francisco at 1 site in United States.
Trial summary
The investigators' general hypothesis is that African-Americans (AAs) smoke more for positive reinforcement from nicotine with a "peak-seeking" pattern of smoking (smoking individual cigarettes more intensively with greater intake of nicotine and tobacco smoke toxins), while whites smoke more for negative… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cigarette Smoking
- What is being tested?
- Deuterated nicotine and cotinine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to Jan 2013
- Phase
- Phase 1
- 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
Who may be able to join
- Sex: male or female (balanced numbers)
- Age: 18- 65
- Race/ethnicity: African-American or White (based on two parents who self- identify as AA or White, respectively)
- Smoking Status: Current daily smoker of at least 10 cigarettes per day; either menthol or non-menthol. Screening saliva cotinine level of > 100 ng/ml.
- Healthy by history and assessment of vital signs.
Who cannot join
- Evidence of cardiac disease by history
- Recent or current history of asthma or severe allergic rhinitis
- Hypertension (blood pressure [BP] >140/90 at screening after 5 min rest)
- Serious medical or psychiatric condition or other condition requiring regular medication use
- Lack of access to a refrigerator to store saliva specimens collected at home
- Morbid obesity (body mass index [BMI]>35)
Show all 12Show fewer
- Current illicit drug use by history and tox screen (however subjects using marijuana may be included if they are not daily users and will agree to abstain from the time of screening until the end of the study)
- Pregnancy or breastfeeding
- Significant history of fainting, "bad veins", discomfort with blood draws
- Current or recent alcohol or drug abuse
- Inability to speak English/read forms or aversion to filling out forms
- Multiple or unexplained "no shows" for screening/study visits or other noncompliance with study procedures
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco, San Francisco General Hospital
San Francisco, California, 94110
About this study
Official title: Nicotine Regulation/Response to Low Yield Cigarettes in African-Americans vs. Whites
The investigators' general hypothesis is that African-Americans (AAs) smoke more for positive reinforcement from nicotine with a "peak-seeking" pattern of smoking (smoking individual cigarettes more intensively with greater intake of nicotine and tobacco smoke toxins), while whites smoke more for negative reinforcement with a "trough-maintaining" pattern (avoiding withdrawal by maintaining more consistent nicotine levels throughout the day by means of a more regular smoking pattern). We, the investigators, believe that these patterns are linked to identifiable racial differences in nicotine pharmacology.
For this study we hypothesize that if AAs behave more like nicotine "peak-seeker" while whites behave more like nicotine "trough-maintainers", that AAs will respond to switching from regular to low nicotine yield commercial cigarettes by smoking each cigarette relatively more intensively with a relatively smaller increase in daily cigarette consumption (cigarettes per day or CPD) as compared to whites.
Read the detailed description
Several lines of evidence indicate that AAs are more highly addicted to cigarette smoking than are whites. AAs are more likely to smoke their first cigarette within 10 minutes of awakening, an indicator of the severity of the dependence. They are more likely to want to quit smoking and are more likely to try to quit (attempts lasting at least 24 hours, but are significantly less likely than whites to be successful abstainers at one year. The quit ratio (former smokers/ever smokers) was recently reported to be 37.3% in AAs compared to 51% for whites (2).
NICOTINE REGULATION IN AAS AND WHITES: In general smokers regulate (titrate) their smoking to take in about the same amount of nicotine from day to day. This behavior is well demonstrated in studies of smokers smoking commercial cigarettes of differing yields, showing that smokers take in similar amounts of nicotine from high- and low-yield cigarettes. NCI MONOGRAPH 13 summarized the data on nicotine and low yield cigarettes and concluded that low yield cigarettes presented the same health risks as high yield cigarettes (12). However, most or all of the research on nicotine titration appears to have been done primarily in white smokers.
We believe that nicotine titration patterns will differ in AAs compared to whites, based on the hypothesis that AAs smoke more for the positive reinforcing effects of individual cigarettes, while whites smoke more to maintain a consistent level of nicotine. We predict that the response to switching from regular to low yield cigarettes in AAs will differ in that they will try to take in more nicotine per cigarette by smoking more intensively, but will be less likely to try to regulate their total daily intake of nicotine compared to whites.
Melanin: A recent study (14) showed that levels of facultative melanin (includes both genetically and exposure influenced melanin) in the skin are significantly and positively related to cigarettes per day, the Fagerstrom score, and cotinine levels. By measuring melanin levels in our own study subjects, we will be able to determine if there is a relationship between melanin levels and nicotine pharmacokinetics.
This is a non-randomized, non-blinded, two treatment arm crossover study with an oral nicotine and cotinine pharmacokinetic study. Cigarettes will be supplied for both treatment arms and subjects will smoke ad libitum. During the first arm, the subject will smoke their "usual" cigarettes and also undergo an oral pharmacokinetics protocol. During the second arm, subjects will smoke a commercial cigarette with a machine-determined nicotine yield of approximately 50% of their "usual" brand.
Blood and urine samples will be collected throughout the study and analyzed by our usual methods.
- Conditions
- Cigarette Smoking
- Being tested
- Deuterated nicotine and cotinine
- Keywords
- Smoking, nicotine
- Medical subject headings
- Cigarette Smoking, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deuterated nicotine and cotinineDrug
used as a marker for pharmacokinetic studies
| Study group | Role | What they receive |
|---|---|---|
| Usual Cigarette | Experimental | African American and White Smokers will smoke their usual cigarette and also undergo an oral pharmacokinetics protocol after administration of 3 mg deuteriumlabeled nicotine and 5 mg deuterium-labeled cotinine. Receives: Drug: Deuterated nicotine and cotinine |
| Low-yield Cigarette | Experimental | African American and White smokers will smoke a commercial cigarette with a machine-determined nicotine yield of approximately 50% of their "usual" brand. Receives: Drug: Deuterated nicotine and cotinine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nicotine clearance
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2010 (estimated)
- Study startDec 2009
- 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 Cigarette SmokingStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neal L Benowitz, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01058876
- Sponsor's protocol ID
- 10-00158
- Other IDs
- NIDA DA002277
- Acronym
- 6162-AAPK2
- Status last verified
- May 2013
- First submitted
- 27 Jan 2010
- Last updated
- 24 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nicotine Regulation/Response to Low Yield Cigarettes in African-Americans vs. Whites
- ClinicalTrials.gov ID
- NCT01058876
- Acronym / sponsor ID
- 6162-AAPK2 / 10-00158
- Conditions
- Cigarette Smoking
- Keywords
- Smoking, nicotine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 29 Jan 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.
The investigators' general hypothesis is that African-Americans (AAs) smoke more for positive reinforcement from nicotine with a "peak-seeking" pattern of smoking (smoking individual cigarettes more intensively with greater intake of nicotine and tobacco smoke toxins), while whites smoke more for negative reinforcement with a "trough-maintaining" pattern (avoiding withdrawal by maintaining more consistent nicotine levels throughout the day by means of a more regular smoking pattern). We, the investigators, believe that these patterns are linked to identifiable racial differences in nicotine pharmacology.
For this study we hypothesize that if AAs behave more like nicotine "peak-seeker" while whites behave more like nicotine "trough-maintainers", that AAs will respond to switching from regular to low nicotine yield commercial cigarettes by smoking each cigarette relatively more intensively with a relatively smaller increase in daily cigarette consumption (cigarettes per day or CPD) as compared to whites.
Detailed description
Several lines of evidence indicate that AAs are more highly addicted to cigarette smoking than are whites. AAs are more likely to smoke their first cigarette within 10 minutes of awakening, an indicator of the severity of the dependence. They are more likely to want to quit smoking and are more likely to try to quit (attempts lasting at least 24 hours, but are significantly less likely than whites to be successful abstainers at one year. The quit ratio (former smokers/ever smokers) was recently reported to be 37.3% in AAs compared to 51% for whites (2).
NICOTINE REGULATION IN AAS AND WHITES: In general smokers regulate (titrate) their smoking to take in about the same amount of nicotine from day to day. This behavior is well demonstrated in studies of smokers smoking commercial cigarettes of differing yields, showing that smokers take in similar amounts of nicotine from high- and low-yield cigarettes. NCI MONOGRAPH 13 summarized the data on nicotine and low yield cigarettes and concluded that low yield cigarettes presented the same health risks as high yield cigarettes (12). However, most or all of the research on nicotine titration appears to have been done primarily in white smokers.
We believe that nicotine titration patterns will differ in AAs compared to whites, based on the hypothesis that AAs smoke more for the positive reinforcing effects of individual cigarettes, while whites smoke more to maintain a consistent level of nicotine. We predict that the response to switching from regular to low yield cigarettes in AAs will differ in that they will try to take in more nicotine per cigarette by smoking more intensively, but will be less likely to try to regulate their total daily intake of nicotine compared to whites.
Melanin: A recent study (14) showed that levels of facultative melanin (includes both genetically and exposure influenced melanin) in the skin are significantly and positively related to cigarettes per day, the Fagerstrom score, and cotinine levels. By measuring melanin levels in our own study subjects, we will be able to determine if there is a relationship between melanin levels and nicotine pharmacokinetics.
This is a non-randomized, non-blinded, two treatment arm crossover study with an oral nicotine and cotinine pharmacokinetic study. Cigarettes will be supplied for both treatment arms and subjects will smoke ad libitum. During the first arm, the subject will smoke their "usual" cigarettes and also undergo an oral pharmacokinetics protocol. During the second arm, subjects will smoke a commercial cigarette with a machine-determined nicotine yield of approximately 50% of their "usual" brand.
Blood and urine samples will be collected throughout the study and analyzed by our usual methods.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Cigarette | Experimental | Drug: Deuterated nicotine and cotinineAfrican American and White Smokers will smoke their usual cigarette and also undergo an oral pharmacokinetics protocol after administration of 3 mg deuteriumlabeled nicotine and 5 mg deuterium-labeled cotinine. |
| Low-yield Cigarette | Experimental | Drug: Deuterated nicotine and cotinineAfrican American and White smokers will smoke a commercial cigarette with a machine-determined nicotine yield of approximately 50% of their "usual" brand. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Sex: male or female (balanced numbers)
- Age: 18- 65
- Race/ethnicity: African-American or White (based on two parents who self- identify as AA or White, respectively)
- Smoking Status: Current daily smoker of at least 10 cigarettes per day; either menthol or non-menthol. Screening saliva cotinine level of > 100 ng/ml.
- Healthy by history and assessment of vital signs.
Key exclusion criteria (12 listed)
- Evidence of cardiac disease by history
- Recent or current history of asthma or severe allergic rhinitis
- Hypertension (blood pressure [BP] >140/90 at screening after 5 min rest)
- Serious medical or psychiatric condition or other condition requiring regular medication use
- Lack of access to a refrigerator to store saliva specimens collected at home
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 |
|---|---|---|
| Deuterated nicotine and cotinineused as a marker for pharmacokinetic studies | Drug | Low-yield Cigarette, Usual Cigarette |
Primary outcome
Nicotine clearance
Time frame: 14 days
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 24 May 2013.
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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.
Neal L Benowitz, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Deuterated nicotine and cotinine in people with Cigarette Smoking, run by University of California, San Francisco 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 5 inclusion and 12 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 24 May 2013. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Nicotine clearance (time frame: 14 days). 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 24 May 2013.