Cigarette Smoking Toxicity
Conditions
Keywords
menthol cigarettes
Brief summary
This study will examine how menthol affects smoking when menthol smokers switch to non-menthol cigarettes. Participants will smoke their preferred brand (control) or Camel Crush cigarettes, which have the ability to be menthol or non-menthol. Participants given Camel Crush cigarettes will smoke them as menthol, then non-menthol cigarettes for 15 days each. Participants will provide breath and urine samples, track cigarette usage and complete smoking topography assessments of smoking behavior.
Detailed description
This study will examine how menthol affects smoking behaviors and biomarker level when menthol smokers switch to non-menthol cigarettes. Participants will initially smoke their preferred brand (control) cigarettes, followed by smoking Camel Crush cigarettes, which have the ability to be menthol or non-menthol. Participants given Camel Crush cigarettes will smoke them as menthol, then non-menthol cigarettes for 15 days each. Participants will provide breath and urine samples to measure smoke exposures, track cigarette usage to establish changes in daily cigarette consumption and complete smoking topography assessments of smoking behavior, such as puff volume.
Interventions
OTHERMenthol to non-menthol
Switch from smoking menthol to non-menthol cigarettes.
Sponsors
National Institutes of Health (NIH)
National Cancer Institute (NCI)
National Institute of Environmental Health Sciences (NIEHS)
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Self-report smoking daily cigarettes * Self-report smoking menthol flavored cigarettes * Not currently trying to quit or planning to quit in the next 2 months. * Interested in trying a novel cigarette product and willing to smoke a non-menthol cigarette * Self-report smoking only filtered commercially made cigarettes
Exclusion criteria
* Self-report drinking equal to or greater than a certain number of alcohol-containing drinks per week * Self report using any nicotine replacement products or nicotine-containing products other than cigarettes * Self-report substance use disorders in the last 5 years * Self-report current Axis I psychiatric disorders * Self-report past history of Axis I psychiatric disorders other than depression * Self-report myocardial infarction, angina or abnormal rhythms requiring medication * Self-report use of select medications and illicit drugs within past six months * Females must not be currently pregnant, planning a pregnancy during the study, or currently breastfeeding/lactating * Provide a baseline carbon monoxide (CO) reading \< 10 ppm at initial session * Inability to provide informed consent or complete any of the study tasks as determined by the Principal Investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Smoking Topography- Puff Volume | over 35 day study period | The total puff volume for a single subject is the sum of puff volumes for a subject's cigarette smoked during the study session. The mean puff volume for the subjects will be used to examine the effect of cigarette menthol on smoking topography. The values provided are the average of subjects at study Day 5 (completion of baseline smoking own cigarettes), Day 20 and Day 35. |
| Smoking Topography- Carbon Monoxide Boost | Measured before and after each cigarette smoked at study sessions | Carbon monoxide content in exhaled breath samples is measured before and after each cigarette smoked during study sessions. CO boost is the amount in parts per million that the subject's CO increases. |
| Nicotine Levels | 35 days | Urine nicotine levels will be measured to examine the effect of cigarette menthol on harm exposure measures. Participants provided samples on the final day of each period. NNK and 1-hop were not analyzed, total nicotine metabolites were assayed. |
| Subjective Rating of Cigarettes | Immediately after a cigarette smoked at the study session | Subjects completed a visual analog scale rating each cigarette smoked at each session. Subjects rated characteristics of the cigarette on a scale represented as a continuous horizontal line 10 cm long. Subjects drew an intersecting line to represent their rating. The rating reported is for the taste of the cigarette at the end of the period averaged across subjects in the group. A rating of 0 corresponds to Very Bad and a rating of 100 to Very Good for taste. There is no better or worse outcome for higher or lower ratings for taste. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from the local Philadelphia area via newspaper and internet advertising. Former study participants who had agreed to be contacted for future studies were also contacted. Recruitment began October 2010 and was completed November 2011.
Pre-assignment details
Subjects were required to complete a 5 day baseline assessment of smoking their own brand cigarette. Participants who did this were given study cigarettes. 87 participants signed consents at the first session, 3 did not finish the session. 60 subjects did the 5 day baseline smoking, returned on Day 5, were randomized and included for analysis.
Participants by arm
| Arm | Count |
|---|---|
| Experimental Group switched from menthol cigarette to non-menthol cigarette | 45 |
| Control Participants smoked their own menthol brand cigarette throughout the study. | 15 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 21 |
| Overall Study | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | Control | Experimental | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 45 Participants | 60 Participants |
| Age, Continuous | 37.93 years STANDARD_DEVIATION 12.1 | 37.13 years STANDARD_DEVIATION 10.9 | 37.4 years STANDARD_DEVIATION 11.7 |
| Region of Enrollment United States | 15 participants | 45 participants | 60 participants |
| Sex: Female, Male Female | 11 Participants | 25 Participants | 36 Participants |
| Sex: Female, Male Male | 4 Participants | 20 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 45 |
Outcome results
Primary
Nicotine Levels
Urine nicotine levels will be measured to examine the effect of cigarette menthol on harm exposure measures. Participants provided samples on the final day of each period. NNK and 1-hop were not analyzed, total nicotine metabolites were assayed.
Time frame: 35 days
Population: Those completing Day 5, returning sample for assay
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental | Nicotine Levels | Period 1 Baseline Own cigarette | 2.2 micrograms/mL | Standard Error 0.82 |
| Experimental | Nicotine Levels | Period 2 Own cigarette or CCrush non-menthol | 3.4 micrograms/mL | Standard Error 1 |
| Experimental | Nicotine Levels | Period 3 Own cigarette or CCrush non-menthol | 2.8 micrograms/mL | Standard Error 1.1 |
| Control | Nicotine Levels | Period 3 Own cigarette or CCrush non-menthol | 2.49 micrograms/mL | Standard Error 0.43 |
| Control | Nicotine Levels | Period 1 Baseline Own cigarette | 1.7 micrograms/mL | Standard Error 0.3 |
| Control | Nicotine Levels | Period 2 Own cigarette or CCrush non-menthol | 2.7 micrograms/mL | Standard Error 0.54 |
Primary
Smoking Topography- Carbon Monoxide Boost
Carbon monoxide content in exhaled breath samples is measured before and after each cigarette smoked during study sessions. CO boost is the amount in parts per million that the subject's CO increases.
Time frame: Measured before and after each cigarette smoked at study sessions
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental | Smoking Topography- Carbon Monoxide Boost | Period 1 Baseline Own cigarette | 5.9 parts per million | Standard Error 0.8 |
| Experimental | Smoking Topography- Carbon Monoxide Boost | Period 2 Own cigarette or CCrush menthol | 3.7 parts per million | Standard Error 0.5 |
| Experimental | Smoking Topography- Carbon Monoxide Boost | Period 3 Own cigarette or CCrush non-menthol | 3.9 parts per million | Standard Error 0.5 |
| Control | Smoking Topography- Carbon Monoxide Boost | Period 1 Baseline Own cigarette | 5.3 parts per million | Standard Error 0.7 |
| Control | Smoking Topography- Carbon Monoxide Boost | Period 2 Own cigarette or CCrush menthol | 5.7 parts per million | Standard Error 0.6 |
| Control | Smoking Topography- Carbon Monoxide Boost | Period 3 Own cigarette or CCrush non-menthol | 5.5 parts per million | Standard Error 0.8 |
Primary
Smoking Topography- Puff Volume
The total puff volume for a single subject is the sum of puff volumes for a subject's cigarette smoked during the study session. The mean puff volume for the subjects will be used to examine the effect of cigarette menthol on smoking topography. The values provided are the average of subjects at study Day 5 (completion of baseline smoking own cigarettes), Day 20 and Day 35.
Time frame: over 35 day study period
Population: Those completing Study session 2 at Day 5.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental | Smoking Topography- Puff Volume | Period 1 Own cigarette | 518 mL | Standard Error 37 |
| Experimental | Smoking Topography- Puff Volume | Period 2 Own cigarette or CCrush menthol | 650 mL | Standard Error 48 |
| Experimental | Smoking Topography- Puff Volume | Period 3 Own cigarette or CCrush non-menthol | 678 mL | Standard Error 57 |
| Control | Smoking Topography- Puff Volume | Period 1 Own cigarette | 661 mL | Standard Error 36 |
| Control | Smoking Topography- Puff Volume | Period 2 Own cigarette or CCrush menthol | 620 mL | Standard Error 41 |
| Control | Smoking Topography- Puff Volume | Period 3 Own cigarette or CCrush non-menthol | 645 mL | Standard Error 37 |
Primary
Subjective Rating of Cigarettes
Subjects completed a visual analog scale rating each cigarette smoked at each session. Subjects rated characteristics of the cigarette on a scale represented as a continuous horizontal line 10 cm long. Subjects drew an intersecting line to represent their rating. The rating reported is for the taste of the cigarette at the end of the period averaged across subjects in the group. A rating of 0 corresponds to Very Bad and a rating of 100 to Very Good for taste. There is no better or worse outcome for higher or lower ratings for taste.
Time frame: Immediately after a cigarette smoked at the study session
Population: Completed measure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental | Subjective Rating of Cigarettes | Period 1 Own cigarette | 80 units on a scale | Standard Error 8.1 |
| Experimental | Subjective Rating of Cigarettes | Period 2 Own cigarette or CCrush menthol | 72 units on a scale | Standard Error 7.3 |
| Experimental | Subjective Rating of Cigarettes | Period 3 Own cigarette or CCrush non-menthol | 71 units on a scale | Standard Error 6.2 |
| Control | Subjective Rating of Cigarettes | Period 1 Own cigarette | 61 units on a scale | Standard Error 5.3 |
| Control | Subjective Rating of Cigarettes | Period 2 Own cigarette or CCrush menthol | 52 units on a scale | Standard Error 5.8 |
| Control | Subjective Rating of Cigarettes | Period 3 Own cigarette or CCrush non-menthol | 39 units on a scale | Standard Error 5.7 |