Evaluation of Oral Tobacco as a Harm Reduction Method for Smokers
| Status: | Completed |
|---|---|
| Conditions: | Smoking Cessation, Tobacco Consumers |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 4/21/2016 |
| Start Date: | August 2008 |
| End Date: | December 2009 |
Study 1: Preference, Health Effects and Efficacy of Four Oral Tobacco Products for Smoking Cessation
Recently, tobacco companies have developed new oral tobacco products that are purportedly
less harmful than conventional tobacco products. These products have not been tested by
independent research for their health effects or consumer palatability. In addition, it is
not known if these products will be used in addition to cigarette smoking or as a substitute
to cigarettes. These two studies will examine four oral tobacco products to answer some of
these questions.
The goals of this first study will be to examine: 1) the brand of oral tobacco products
which is preferred by cigarette smokers and the pattern and amount of product use when used
as a switching tool; 2) the characteristics that are associated with product choice; 3)
nicotine exposure from these products; and 4) the withdrawal symptoms from the tobacco
products and potential for continued use.
Specifically, our primary aims hypotheses were: 1) the product that will be chosen by most
smokers will be based on taste and sensory aspects of the product with products higher in
nicotine content more likely to be chosen as the preferred product; and 2) subjects will
experience no difficulty using the product for cessation, but a small minority will engage
in dual product use.
For the secondary aims, we hypothesized: 1) that compared to the subjects' own brand of
cigarettes, the biomarkers for exposure for the oral tobacco products will be significantly
lower; 2) withdrawal symptoms from the oral products are likely to occur, but are likely to
be mild compared to cigarette withdrawal.
less harmful than conventional tobacco products. These products have not been tested by
independent research for their health effects or consumer palatability. In addition, it is
not known if these products will be used in addition to cigarette smoking or as a substitute
to cigarettes. These two studies will examine four oral tobacco products to answer some of
these questions.
The goals of this first study will be to examine: 1) the brand of oral tobacco products
which is preferred by cigarette smokers and the pattern and amount of product use when used
as a switching tool; 2) the characteristics that are associated with product choice; 3)
nicotine exposure from these products; and 4) the withdrawal symptoms from the tobacco
products and potential for continued use.
Specifically, our primary aims hypotheses were: 1) the product that will be chosen by most
smokers will be based on taste and sensory aspects of the product with products higher in
nicotine content more likely to be chosen as the preferred product; and 2) subjects will
experience no difficulty using the product for cessation, but a small minority will engage
in dual product use.
For the secondary aims, we hypothesized: 1) that compared to the subjects' own brand of
cigarettes, the biomarkers for exposure for the oral tobacco products will be significantly
lower; 2) withdrawal symptoms from the oral products are likely to occur, but are likely to
be mild compared to cigarette withdrawal.
This study will be accomplished by allowing subjects to sample the products and choose one
oral tobacco product that they will use instead of cigarettes for a two week period. After
the two weeks, they will discontinue all tobacco use and withdrawal symptoms and abstinence
rates will be observed.
Subjects will attend an orientation visit where the study will be explained in detail.
Interested subjects will sign a consent form and be scheduled to return for baseline
measures. Subjects will have a review of medical history to verify that they are in
generally good health and do not have contraindications to the study products. Eligible
subjects will collect one week of baseline measures while smoking at their normal rate:
measures include daily diaries of smoking, questionnaires and urine samples. At the second
baseline visit, they will receive samples of the oral tobacco products. The tobacco products
tested are five novel oral products recently introduced to the market: 1) Camel Snus (higher
nicotine); 2) General Snus (higher nicotine); 3) Marlboro Snus (lower nicotine); and two
compressed tobacco tablets, 4) Ariva (lower nicotine), or 5) Stonewall (higher nicotine).
All of these tobacco products are purported to have reduced levels of tobacco-specific
nitrosamines.
During sample weeks, subjects will be given 10 pouches/tablets of each product in a
within-subject design and instructed to use at least three of the daily products in the
morning of sample day and resume smoking in the afternoon and through the following day.
They will sample the next product in a similar manner. The order of product was randomized.
This design will allow a short, but adequate trial of each product to determine preference.
After the sampling weeks, subjects will choose the product they will want to use to quit
smoking. They will be supplied that product over the next two weeks.
During the two weeks of product use during smoking cessation, subjects will come to weekly
clinic visits and then a follow-up visits at 1 week and a phone call at 4 weeks after the
end of treatment. At baseline, and 2 weeks post cigarette cessation, subjects will bring in
a urine sample from their first morning void and bloods will be drawn. These samples will be
analyzed for cotinine. At each visit, subjects will have vital signs obtained (blood
pressure, heart rate, weight and carbon monoxide level), they will complete several
subjective forms regarding tobacco use, withdrawal symptoms, and mood. Subjects will receive
brief behavioral counseling for smoking cessation at all visits.
In addition, during the sample weeks and at the end of two weeks of study product use,
subjects will submit three used chews that will be sent to CDC to be analyzed for the
tobacco constituents.
oral tobacco product that they will use instead of cigarettes for a two week period. After
the two weeks, they will discontinue all tobacco use and withdrawal symptoms and abstinence
rates will be observed.
Subjects will attend an orientation visit where the study will be explained in detail.
Interested subjects will sign a consent form and be scheduled to return for baseline
measures. Subjects will have a review of medical history to verify that they are in
generally good health and do not have contraindications to the study products. Eligible
subjects will collect one week of baseline measures while smoking at their normal rate:
measures include daily diaries of smoking, questionnaires and urine samples. At the second
baseline visit, they will receive samples of the oral tobacco products. The tobacco products
tested are five novel oral products recently introduced to the market: 1) Camel Snus (higher
nicotine); 2) General Snus (higher nicotine); 3) Marlboro Snus (lower nicotine); and two
compressed tobacco tablets, 4) Ariva (lower nicotine), or 5) Stonewall (higher nicotine).
All of these tobacco products are purported to have reduced levels of tobacco-specific
nitrosamines.
During sample weeks, subjects will be given 10 pouches/tablets of each product in a
within-subject design and instructed to use at least three of the daily products in the
morning of sample day and resume smoking in the afternoon and through the following day.
They will sample the next product in a similar manner. The order of product was randomized.
This design will allow a short, but adequate trial of each product to determine preference.
After the sampling weeks, subjects will choose the product they will want to use to quit
smoking. They will be supplied that product over the next two weeks.
During the two weeks of product use during smoking cessation, subjects will come to weekly
clinic visits and then a follow-up visits at 1 week and a phone call at 4 weeks after the
end of treatment. At baseline, and 2 weeks post cigarette cessation, subjects will bring in
a urine sample from their first morning void and bloods will be drawn. These samples will be
analyzed for cotinine. At each visit, subjects will have vital signs obtained (blood
pressure, heart rate, weight and carbon monoxide level), they will complete several
subjective forms regarding tobacco use, withdrawal symptoms, and mood. Subjects will receive
brief behavioral counseling for smoking cessation at all visits.
In addition, during the sample weeks and at the end of two weeks of study product use,
subjects will submit three used chews that will be sent to CDC to be analyzed for the
tobacco constituents.
Inclusion Criteria:
- Cigarette smokers who smoke 10 or more cigarettes per day
- Generally good health
Exclusion Criteria:
- Unstable medical or psychiatric condition.
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