US smokers' reactions to a brief trial of oral nicotine products
© O'Connor et al; licensee BioMed Central Ltd. 2011
Received: 18 June 2010
Accepted: 10 January 2011
Published: 10 January 2011
It has been suggested that cigarette smokers will switch to alternative oral nicotine delivery products to reduce their health risks if informed of the relative risk difference. However, it is important to assess how smokers are likely to use cigarette alternatives before making predictions about their potential to promote individual or population harm reduction.
This study examines smokers' interest in using a smokeless tobacco or a nicotine replacement product as a substitute for their cigarettes.
The study included 67 adult cigarette smokers, not currently interested in quitting, who were given an opportunity to sample four alternative oral nicotine products: 1) Camel Snus, 2) Marlboro Snus, 3) Stonewall dissolvable tobacco tablets, and 4) Commit nicotine lozenges. At visit 1, subjects were presented information about the relative benefits/risks of oral nicotine delivery compared to cigarettes. At visit 2, subjects were given a supply of each of the four products to sample at home for a week. At visit 3, subjects received a one-week supply of their preferred product to see if using such products reduced or eliminated cigarette use.
After multiple product sampling, participants preferred the Commit lozenges over the three smokeless tobacco products (p = 0.011). Following the one week single-product trial experience, GEE models controlling for gender, age, level of education, baseline cigarettes use, and alternative product chosen, indicated a significant decline in cigarettes smoked per day across one week of single-product sampling (p < 0.01, from 11.8 to 8.7 cigarettes per day), but no change in alternative product use (approximately 4.5 units per day). Biomarkers of exposure showed no change in cotinine, but a 19% reduction in exhaled CO (p < 0.001).
Findings from this study show that smokers, who are currently unwilling to make a quit attempt, may be willing to use alternative products in the short term as a temporary substitute for smoking. However, this use is more likely to be for partial substitution (i.e. they will continue to smoke, albeit at a lower rate) rather than complete substitution. Of the various substitutes offered, smokers were more willing to use a nicotine replacement product over a tobacco-based product.
While the harms of tobacco smoking have been well documented for decades, more than 20% of US adults continue to smoke. This seeming lack of progress has led to interest in harm reduction as a complementary tobacco control strategy, particularly with products that offer reduced toxicity to individual users. Two products that have received substantial discussion as potential harm reduction options are smokeless tobacco (particularly low-toxin forms such as Swedish snus) and nicotine replacement therapy (medicinal nicotine), which is currently approved only for limited duration use in smoking cessation[3–7]. However, the promotion of reduced harm products, especially smokeless tobacco, remains controversial. Commonly expressed concerns include a lack of reliable data on health risk reduction (as opposed to exposure), impacts on smoking behavior (e.g., dual use and continued nicotine dependence), and the potential attractiveness of products to former and non-users of tobacco, especially youth[2, 8–11]. Further complicating matters is the fact that since 2005, major cigarette manufacturers have, either through partnership or acquisition, moved into the smokeless tobacco business. This has allowed tobacco manufacturers to introduce smokers to new smokeless tobacco products for use in situations where smoking is restricted[12–14].
Consumer perceptions and responses are key components to understanding the adoption and maintenance of new and modified tobacco products. The Family Smoking Prevention and Tobacco Control Act of 2009 (FSPTCA) empowers the FDA to regulate tobacco products by considering consumer perceptions in decisions about regulations "appropriate for the protection of public health". So, knowing what users believe about products, and their reactions to those products, are recognized to be important to understanding how smokeless tobacco and medicinal nicotine are likely to be used and thus their potential as substitutes for cigarettes. However, independent research has been limited in this area. Timberlake  found only 13% of California smokers were receptive to using smokeless tobacco instead of smoking. Studies outside North America have found that 34% of New Zealand smokers and 48% of Australian smokers were interested in trying smokeless tobacco[18, 19]. Interest in switching from cigarettes to an alternative form of nicotine delivery may depend on smokers' preexisting beliefs about alternative products. Data consistently show that consumers incorrectly believe nicotine causes cancer,[20–22] and that smokeless tobacco products are as, if not more, dangerous than cigarettes[23–26]. So, the information presented about products may be an important factor in influencing interest. Shiffman and colleagues  presented smokers with descriptions of both medicinal nicotine and tobacco-based products positioned as smoking substitutes, and found that smokers generally preferred the medicinal nicotine products to the tobacco-based products. On the other hand, Heavner and colleagues surveyed smokers in Edmonton, Canada, and reported that 75% were willing to try a hypothetical product carrying 99% less risk than smoking. However, neither of these studies involved direct experience.
Recently, Carpenter and Gray  reported that, compared to continued smoking, use of Ariva or Stonewall compressed tobacco lozenges reduced cigarette consumption and increased intentions to quit. A series of studies by Schneider and colleagues [30–32] examined preferences among different nicotine replacement products, concluding that individuals have varied reactions to different nicotine delivery modes, and sampling of treatments can identify key reactions that predict later quitting success. Caldwell and colleagues  found that, among heavy smokers given two-weeks experience, snus or Zonnic oral nicotine sachet were preferred over nicotine gum. Cobb and colleagues  using a series of laboratory sessions with smokers, showed that non-combustible products (Ariva, Camel Snus, Marlboro Snus, Commit) delivered less nicotine than smokers usual brand of cigarettes and failed to suppress tobacco abstinence symptoms as effectively as cigarettes. Overall, the literature suggests that it is important to try to assess smokers' reactions to proposed cigarette alternatives before making predictions about their potential to promote harm reduction relative to continued smoking.
The present study was designed to examine smokers' interest in using a smokeless tobacco (SL) or nicotine replacement product (NR) as a substitute for their cigarettes. Specifically, we set out to address three questions: 1) Among various options, which alternative source of oral nicotine delivery do smokers prefer? 2) When given an opportunity to use their preferred product, how would they use it (i.e., complete or partial substitution)? 3) Would brief ad libitum use of the oral nicotine substitute alter exposure to cigarettes as assessed by CPD, carbon monoxide and nicotine levels?
Demographic characteristics of study participants (N = 67).
Lost to follow-up
(n = 23)
(n = 44)
Highest Level of Education
Less than HS
More than HS
41 - 54
Intention to Quit in the next year
How addicted do you consider yourself?
Not at all
Prior use of NR
Prior use of ST
Cigarettes per Day
Minutes to First Cigarette after Waking
All test products were purchased on the open market in 2008 and previous studies have examined characteristics of these or similar products[35–37]. At the end of Session 2, participants were provided with samples of three smokeless tobacco products [one container each of Camel Snus, 20 pouches; Marlboro Snus, 12 pouches; and Stonewall Hard Snuff, 20 tablets] and one package of oral nicotine replacement product (Commit® Lozenge, 24 4 mg lozenges). The smokeless products contained varying amounts of free nicotine - from 0.7 mg/g (Marlboro Snus Mint) to 1.5 mg/g (Stonewall) to 6.4 mg/g (Camel Snus Frost)[36, 37]. For standardization purposes, all products were offered only in their 'mint' versions, so that the availability of specific flavors would not drive selections. At the end of Session 3, participants selected one of these four products to use for an additional week and received 7 containers/packages of that product.
Questionnaire items focused on the specific SL/NR products offered and their experiences with the products, including which product overall they liked most/least, willingness to use the products instead of smoking under a range of scenarios, and interest in actually continuing to use such products as a partial or complete replacement for cigarettes. Participants were also asked a series of questions pertaining to their willingness to pay for the smokeless and nicotine replacement products. Daily diaries were used to track numbers of cigarettes and substitute products used each day. At baseline participants self-reported their usual number of cigarettes per day and time to first cigarette after waking, which were recoded into the Heavy Smoking Index (HSI) . Exhaled CO was tested using a Micro 4 Smokerlyzer (Bedfont, UK) using standard protocols. Cotinine in saliva was tested using the EIA method by an outside laboratory (Salimetrics LLC, University Park, PA).
All analyses were performed using SPSS 16.0 (Chicago, IL). Descriptive statistics and frequencies were used to initially characterize the data. Kendall's tau-b was used to examine concordance between product rankings. Change in responses over time was examined using paired t-tests. Cotinine values were transformed using the natural logarithm to normalize the distribution prior to analysis. Generalized estimating equations (GEE) with log link and first-order autoregressive working correlation matrix were applied to examine daily patterns of product use; a normal distribution best fit models of cigarette use, while a gamma distribution best fit models of alternative product use. Statistical significance was accepted at a p-value of <0.05.
Alternative product preferences (N = 50).
Commit 4 mg
Proportion of supplied units used (Median, IQR)
χ2(3) = 589.31
p = 0.003 a
Proportion of all products used (Median, IQR)
χ2(3) = 142.2
p = 0.524 a
χ2(3) = 005.31
Product Liked Most (%)
p = 0.004 b
χ2(3) = 333.8
Product Liked Least (%)
p = 0.040 b
χ2(3) = 519.8
Product believed to contain most nicotine (%)
p = 0.030 b
χ2(3) = 944.31
Product selected for one-week trial (%)c
p = 0.004 b
Patterns of use
Parameter Estimates from GEE modeling of cigarette and alternative product use during multiple product sampling and single-product trial phases.
Wald χ 2 (df = 1)
Wald χ 2 (df = 1)
MULTIPLE PRODUCT SAMPLING PHASE
Female (ref = Male)
Less than HS (ref = More than HS)
HS graduate (ref = More than HS)
40 and under (ref = 55 and older)
41-54 (ref = 55 and older)
Camel Snus (ref = Stonewall)
Marlboro Snus (ref = Stonewall)
Commit (ref = Stonewall)
SINGLE PRODUCT TRIAL PHASE
Female (ref = Male)
Less than HS (ref = More than HS)
HS graduate (ref = More than HS)
40 and under (ref = 55 and older)
41-54 (ref = 55 and older)
Camel Snus (ref = Stonewall)
Marlboro Snus (ref = Stonewall)
Commit (ref = Stonewall)
Participant likelihood to use, purchase, & pay for alternative products.(N = 44)
Preferred product (Overall)
Commit 4 mg
Likely to use instead of cigarettes (%)
χ2(6) = 96.4
p = 0.584
Not at all
Likely to use in addition to cigarettes (%)
χ2(6) = 52.6
p = 0.396
Not at all
Likely to purchase in next year (%)
χ2(6) = 12.7
p = 0.302
Not at all
Price willing to pay for one package ($)
χ2(3) = 11.81
p < 0.001
Patterns of Use
Biomarkers of exposure
Exhaled CO decreased significantly from before to after the one-week trial. Exhaled CO before any use of alternative products (Session 2) averaged 18.7 ppm (SD 7.0), and dropped after the one week trial (Session 4) to an average of 14.9 ppm (SD 7.2), a decline of 10% [t(43) = 4.149; p < 0.001]. Overall, 75% of participants demonstrated a decrease in breath CO levels. Geometric mean salivary cotinine was observed to remain stable; at Session 2 saliva cotinine was 311.0 ng/mL, compared to 311.9 ng/mL at Session 4 [t(41) = -0.043; p = 0.966]. We calculated a compensation index for cotinine relative to CO using the formula COMP = 1 - (ln (COT4) - ln(COT2))/(ln(CO4) - ln(CO2)). The median compensation score was 1.02 (IQR 0.38-1.60), suggesting that on average, smokers in the study compensated completely for their nicotine needs by substituting alternative products. Compensation index did not differ by preferred product [Kruskal-Wallis χ2(3) = 0.76, p = 0.860].
Findings from this study show that smokers who are currently unwilling to make a quit attempt may be open to adopting alternative products in the short term as a temporary substitute for smoking. The two-step trial period allowed us to explore smokers' willingness to try unfamiliar oral nicotine and smokeless tobacco products, as well as their perceptions and acceptability of these products as an alternative to cigarettes. Data suggest that the dominant behavioral pattern was partial substitution, with about twice as many cigarettes consumed compared to oral nicotine products. Although, we observed that cigarette use declined by nearly one-half during the monitoring interval. We did not collect data to inform whether low use of the alternatives was a result of participants 'rationing' product, but given the number of unused portions returned, this was likely not a major problem. It is more likely that participants had not settled on a habitual use pattern, and/or the products were not sufficiently attractive.
Concomitant measurement of biomarkers of exposure revealed a small but significant decrease in breath CO associated with use of alternative products, without any change in salivary cotinine levels. The modest reduction in CO exposure, while statistically significant, is unlikely by itself to qualify as a true reduction in harm. In contrast, the downward trajectory of cigarette use, paired with consistent use of alternative products, suggests that ad libitum use of SL/NR might, over a longer time frame, lead to substantial harm reduction; however, this must be evaluated in longer term studies. The finding of a stable level of substitution over the week of use is consistent with the possibility that smokers, at least those with low interest in quitting, may prefer a gradual shift strategy to an immediate changeover model (as occurs with use of NRT to quit). We cannot predict from the current data whether this process would continue and result in complete substitution, ongoing mixed use, a reversion to cigarettes, or complete cessation of nicotine use.
Similar to Shiffman's survey findings, we also found that among smokers willing to try an oral nicotine product more were interested in using a pharmaceutical nicotine product (Commit) compared to three alternative smokeless tobacco products. This finding of willingness to use a nicotine replacement product for temporary substitution is consistent with prior literature showing substantial use of NRT products for reasons other than quitting (e.g., smoking reduction, temporary abstinence) by smokers [39, 40] The observed preference for the nicotine lozenge counters an implicit assumption [41, 42] that smokers would more likely prefer smokeless tobacco to nicotine products. At the same time, the greater the range of products offered, the greater the proportion of smokers who may find a product they see as a viable substitute for cigarettes. This is consistent with the body of literature [29–34] suggesting that smokers' varied reactions to different products may be informative in themselves, meaning a 'sampling' approach may allow smokers to find an appealing alternative product to cigarettes.
Participants identified Camel Snus as containing the most nicotine and, while it was not preferred by many (14%), a substantial majority (70%) of these reported they were at least somewhat likely to purchase the product in the next year (see Table 4). This observation may be related to the higher 'free' nicotine content in Camel Snus relative to the other products offered. In particular, other investigators have pointed out the discrepancy between Marlboro Snus and Swedish forms in terms of free nicotine . This difference in nicotine may explain the discrepancy in preference between Camel and Marlboro Snus, which might seem superficially equivalent. Moist snuff manufactures have altered free nicotine levels to affect nicotine delivery and appeal to different markets[44, 45]. However, for smokers naïve to oral tobacco products, the higher free nicotine content of Camel Snus may initially have been experienced as aversive while the low free nicotine content of Marlboro Snus may have been insufficiently satisfying to sustain use.
The findings from this study are subject to a number of limitations. About 1/3 of initial participants did not complete all phases of this study, reflecting the challenges of multi-visit studies. The limited number of participants also precluded identifying specific demographic predictors of willingness to substitute or patterns of substitution. We chose not to include a comparison group who continued to use only cigarettes, because our primary interest was observing what smokers might do when presented the opportunity to try a different form of nicotine delivery.
In summary, this study reveals that the nicotine lozenge was viewed more favorably than smokeless tobacco products, as a substitute for cigarettes, which counters some claims that ST would be more acceptable to smokers. However, we observed no true switching (i.e., abandoning cigarettes), even though SL and NR products were provided without cost. It is clear that simply informing smokers of the lower risk and providing products is not going to result in major immediate shifts to smokeless alternatives. In the absence of some significant incentive, it is unlikely that information campaigns alone would lead to migration from use of cigarettes toward less hazardous nicotine sources among United States smokers. Further work is needed of the longer-term effects on attempts at substitution to see if potentially significant effects, in public health terms, can be achieved, or whether encouraging smokeless nicotine use is not a viable substitution strategy.
This work was funded by the National Cancer Institute via the Roswell Park Cancer Institute Transdisciplinary Tobacco Use Research Center (P50CA114236). The funding body had no role in study design; in the collection, analysis, and interpretation of data; in the writing of the manuscript; nor in the decision to submit the manuscript for publication.
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