Clinical trial NCT01202942: Use and Harm Exposure in New Low Nicotine Cigarettes
Official title: Smoking Topography and Harm Exposure in a New Potentially Reduced Exposure Product
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cigarette Smoking
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2010-09-16
Enrollment: 246
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The proposed research extends previous research on Quest® cigarette smoking behavior by testing whether compensatory smoking occurs as cigarette nicotine level decreases, and whether, as a result, biomarkers of harm exposure increase. This hypothesis will be tested in 210 smokers who report smoking at least 15 cigarettes per day and have been smoking for at least five years and are not currently interested in quitting, but interested in trying a new cigarette product. Participants will be randomized to one of three conditions: 1) smoke their own preferred brand (control group); 2) smoke Quest® cigarettes in progressively decreasing cigarette nicotine level (step-down); or 3) Quest® cigarette non-step-down condition, where they will smoke Quest® cigarettes in a random order. The study will consist of 4 stages beginning with a 5-day preferred own brand cigarette smoking phase for all participants, followed by one of the three cigarette conditions. For those smoking Quest® cigarettes, cigarette nicotine level will change every 10 days, either in a step-down or random fashion. The primary behavioral outcome is smoking topography, a quantitative measurement of smoke exposure. Alveolar carbon monoxide (CO), a validated assessment of smoke exposure, and urine samples to assess carcinogen exposure, specifically NNAL (4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol) and 1-HOP (1-hydroxypyrere), and exhaled breath condensate will also be collected at the laboratory visits. At the initiation of the study, participants will view the Quest® print advertisement and complete a survey related to product expectations in order to determine the impact marketing and advertisement has on beliefs, attitudes and behaviors related to Quest® cigarettes.


Eligibility criteria: Inclusion Criteria:

* Self-report smoking \> 15 daily cigarettes.
* Self-report smoking only non-menthol cigarettes.
* Not currently trying to quit smoking, or planning to quit in the next 2 months.
* Interested in trying a new cigarette-like product.

Exclusion Criteria:

* Not meeting any of the inclusion criteria.
* Self-report drinking \> 25 alcohol-containing drinks per week.
* Self-report currently using any nicotine replacement products.
* Self-report substance use disorders (abuse or dependence involving alcohol, cocaine, or stimulants, benzodiazepines, not nicotine) in the last 5 years.
* Self-report past history of Axis I psychiatric disorders other than depression
* Self-report myocardial infarct within the past year.
* Females must not be currently pregnant, planning a pregnancy during the study, or currently breastfeeding/lactating.
* Provide a baseline CO reading \< 10 ppm

Primary outcomes:
measure: Smoking topography measures increase as nicotine levels decrease
timeFrame: Every five days over 35 day study participation
Secondary outcomes:
measure: Nicotine levels effects on smoking topography
timeFrame: Every 5 days over 35 day study participation.
measure: Whether smokers' inferences from advertising affect smoking behavior
timeFrame: Every 5 days over 35 day study participation.
measure: Whether carbon monoxide boost and biomarkers of harm increase as cigarette nicotine levels decrease
timeFrame: Every 5 days over 35 day study participation.
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Tobacco Use Research Center, UPenn
state: Pennsylvania
Study officials:
References: