Smoking
Conditions
Keywords
little cigars, cigarettes, smoking
Brief summary
This study examines the effects of smoking little cigars in different groups of smokers. The investigators are focusing on differences in how smokers' bodies break down and eliminate nicotine from their systems. Some people are fast metabolizers of nicotine, meaning they break down and eliminate nicotine from their bodies more quickly. Other people are slower metabolizers meaning they break down and eliminate nicotine more slowly. The investigators are comparing these two groups of smokers when they switch to smoking cigars instead of cigarettes.
Detailed description
This study examines the effects of switching from cigarette to little cigar smoking on smoking behaviors and toxin exposure in fast and slow nicotine metabolizing smokers. We will recruit current smokers (split between slow and rapid nicotine metabolizing smokers) for a 20-day protocol. Participants will smoke their own brand cigarettes during a baseline 5 day period, followed by 15 days smoking little cigars. This study will use a validated, phenotypic marker of nicotine metabolism rate that may identify those individuals at greatest risk of harm exposure when using little cigars. This study will examine the compensatory effects of little cigars on smoking behaviors and toxin exposure among slow and rapid nicotine metabolizers.
Interventions
OTHERSwitch to smoking only little cigars
Participants smoke only little cigars for 15 days.
Sponsors
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* adults age 21-65. * smoking at least 10 cigarettes per day. * smoking daily for the last 5 years. * Provide a baseline breath CO reading 10 parts per million. * smoke predominantly filtered cigarettes. * not currently using any other nicotine containing products such as smokeless tobacco, nicotine * replacement therapies (patch or gum). * are fluent in English and are capable of providing written informed consent, which includes compliance with the requirements and restrictions listed in the combined consent and HIPAA form. * Have smoked at least 25 cigars in their lifetime * Participants who meet the inclusion/
Exclusion criteria
and attend an Intake Visit for medical screening will be asked to provide a blood sample to determine NMR. Only those individuals who are characterized as slow or rapid, based on NMRs .26, or .42, will be eligible.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of cigars consumed daily | 20 days | The number of cigars smoked each day. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Carbon monoxide measurements | Each study day 0, 5, 10, 15, 20 | — |
| Nicotine metabolites from urine samples | 20 days | Measures of NNK, mercapturic acid metabolites, total nicotine equivalents. |
Countries
United States
Outcome results
None listed