Smoking
Conditions
Keywords
low nicotine, cigarettes, NMR
Brief summary
This study examines the effects of smoking low nicotine cigarettes 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 for their responses to low nicotine cigarettes. The investigators hypothesize that individuals who smoke low nicotine cigarettes may smoke more intensely or smoke more each day, thereby maintaining their desired nicotine levels, and as a result continue to be exposed to significant toxin levels.
Detailed description
This study examines the effects of smoking low nicotine cigarettes 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 35-day protocol. Participants will smoke their own brand cigarettes during a baseline 5 day period, followed by a 15-day period of smoking low nicotine content cigarette level 1: 0.25 mg nicotine content, followed by a 15-day period of smoking low nicotine content cigarette level 2: 0.08 mg nicotine content. This application is designed to provide empirical science to inform the FDA on the effect smoking low nicotine content cigarettes will have on use patterns and harm exposure.
Interventions
OTHERLow nicotine cigarettes
15-day period of smoking low nicotine content cigarette level 1: 0.25 mg nicotine content, followed by a 15-day period of smoking low nicotine content cigarette level 2: 0.08 mg nicotine content.
Sponsors
University of Pennsylvania
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
SINGLE (Subject)
Masking description
All subjects were blinded to the nicotine content of the study cigarettes.
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. adults age 21-65. 2. smoking at least 10 cigarettes per day. 3. smoking daily for the last 5 years. 4. Provide a baseline breath CO reading equal to or greater than 10 parts per million. 5. smoke predominantly non-menthol filtered cigarettes (research cigarettes are only non-menthol). 6. not currently using any other nicotine containing products such as cigars, smokeless tobacco, nicotine replacement therapies (patch or gum). 7. 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. 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 |
|---|---|
| Smoking topography- total puff volume | up to 35 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Daily cigarette consumption | Study day 0, 5, 10, 15, 20, 25, 30, 35 | Total number of cigarettes smoked each day. |
| Urine nicotine metabolite measures | Assessed at Days 5, 20 and 35 | NNK, mercapturic acid metabolites, total nicotine equivalents |
| Carbon monoxide measurements | Study day 0, 5, 10, 15, 20, 25, 30, 35 | — |
Countries
United States
Outcome results
None listed