Abstract
Introduction
Bans of menthol characterizing flavor in cigarettes have been implemented in some localities and have been proposed more broadly. One proposed benefit of such a ban is to increase cessation rates among current menthol smokers. There is currently relatively limited data regarding how smoking behavior changes if menthol smokers switch to non-menthol cigarettes.
Aims and Methods
African American menthol smokers interested in quitting smoking were randomized to either continue smoking menthol (n = 60) or switch to non-menthol cigarettes (n = 62) for 1 month prior to a cessation attempt. Cessation results were reported previously; this analysis reports the results from the pre-cessation visits at which amount smoked, exhaled carbon monoxide (CO) concentration, urinary cotinine concentrations, and subjective measures were assessed.
Results
Over the 4-week study period, those switching to non-menthol (vs. continuing to smoke menthol) cigarettes smoked fewer cigarettes per day (mean ratio: 0.86; 95% confidence interval [CI]: 0.76, 0.98; p = .02), reported lower withdrawal symptom severity (mean difference −1.29; 95% CI: −2.6 to −0.01; p = .05) and higher perceived effectiveness of their skills for quitting smoking (mean difference 0.56; 95% CI: 0.02–1.10; p = .05). No significant differences were found between groups in exhaled CO, urinary cotinine concentrations, or most other subjective effects including support for a ban on menthol characterizing flavor in cigarettes.
Conclusions
These results suggest that were menthol cigarettes no longer available, those that switch to non-menthol cigarettes would not change their smoking behavior in a way that is likely to be more hazardous, with some indicators suggesting that there may be some benefit.
Clinicaltrials.gov # NCT02342327.
Implications
A ban on menthol characterizing flavor in cigarettes has been proposed as a potential means by which to increase smoking cessation rates among current menthol cigarette smokers. This study evaluated how African American menthol cigarette smokers adjusted their smoking behavior after switching to non-menthol cigarettes. Although the overall differences between groups were modest, they were in a direction consistent with decreased smoking suggesting that current smokers would not adjust their behavior in a way that is likely to be more hazardous, with some indicators suggesting that there may be some benefits.
Introduction
The Family Smoking Prevention and Tobacco Control Act authorized the United States Food and Drug Administration (FDA) to ban all characterizing flavors in cigarettes except for menthol and tobacco but directed that a Tobacco Products Scientific Advisory Committee (TPSAC) examine the impact of the use of menthol in cigarettes on the public health.1,2 Although menthol characterizing flavor is not currently broadly banned in the United States, a ban on menthol characterizing flavor in cigarettes has been enacted in other parts of the world and some localities within the United States and a broader ban on menthol in the United States has been discussed.3–5 Considering that approximately 40% of smokers in the United States (including over 80% of African American smokers) smoke menthol cigarettes, regulatory action targeting menthol could potentially affect a large number of current smokers.6
Several reports examining the effect of menthol cigarettes on public health, including the TPSAC report, have concluded that banning menthol would benefit public health in large part because menthol use is likely associated with increased smoking initiation by youth and young adults, and menthol smokers (particularly African American menthol smokers) are less likely to successfully quit smoking.7–10 There is however relatively limited data regarding how current smokers of menthol cigarettes would adjust their behavior in the event of a ban. When responding to surveys, many menthol smokers say that they would quit smoking if menthol cigarettes were banned; however, a study found that when menthol smokers were asked to not smoke menthol cigarettes, the vast majority switched to non-menthol cigarettes rather than quitting.11,12 After switching to non-menthol cigarettes, some studies have found that the number of cigarettes smoked and severity of craving decreased whereas motivation to quit increased suggesting that banning menthol may be a step toward subsequent cessation.12,13 Indeed, a cohort study from Ontario, Canada reported that smoking cessation rates 1 year after a menthol ban was enacted were higher in those who smoked menthol (vs. non-menthol) cigarettes at baseline.14
We conducted a pilot study in which African American smokers of menthol cigarettes were randomized to 1 month of either continuing to smoke their usual brand cigarettes or to switch to non-menthol cigarettes before attempting to quit smoking. Results describing cessation-related outcomes are described elsewhere.15 In the current analysis, we report on the smoking behavior and subjective responses reported during the pre-cessation period. This report therefore provides data regarding how African American menthol smokers who are planning to quit smoking would adjust their smoking behavior were only non-menthol cigarettes available.
Methods
Design
In this study, self-identifying African American menthol cigarette smokers motivated to quit were randomized to either continue smoking menthol cigarettes or switch to non-menthol cigarettes for a 1-month period before attempting to quit smoking. Details regarding procedures and results of the post-cessation visits have been previously published with this report focusing on smoking behavior, biomarkers of cigarette exposure, and subjective measures collected during the 1-month pre-cessation period.15
Participants
Participants in this study were self-identified African Americans, between the ages of 18 and 64 who smoked at least 5 cigarettes per day (on an average day) over the past year of which at least 80% were menthol flavored. At the screening visit, all participants rated themselves ≥7 on a 10-point scale assessing motivation to quit smoking “at this time.” Excluded were those with serious, unstable medical and psychiatric conditions, those taking medications that could interfere with the outcome measures or be affected by changes in smoking status, and women who were pregnant or breast feeding. Smoking status was confirmed via an exhaled carbon monoxide (CO) concentration of ≥8 parts per million (ppm) or for those not meeting the exhaled CO criteria but meeting the minimum smoking criteria a NicAlert of ≥5 (corresponding to a urine cotinine concentration of ≥500 ng/mL). Pregnancy status was confirmed via a urine pregnancy test. All other inclusion/exclusion criteria were based on self-report.
Procedures
This study was approved by the University of Minnesota Institutional Review Board. At a screening visit, written informed consent was obtained and eligibility confirmed. Those eligible were scheduled for a baseline visit timed to occur approximately 4 weeks before participants were to attempt to quit smoking. After the screening visit, participants were asked to record daily the type and number of cigarettes smoked. These smoking diaries were reviewed at each visit.
After the baseline visit, additional visits occurred approximately 1, 2, and 4 weeks later. Participants were asked to quit smoking either on the day prior to or the day of their week 4 visit. At the baseline visit, participants were informed which group they were randomized to and provided cigarettes consistent with their assigned condition at no cost to them. The brand of cigarettes provided was either their usual brand of menthol or their preferred brand of non-menthol cigarette. If no preferred brand was indicated then the non-menthol version of their usual brand was provided. Participants received a quantity of cigarettes equivalent to approximately 120% of their average daily reported use up to a maximum of approximately 1.5 packs per day. Since cigarettes were provided in full packs, these percentages were approximations. At each visit, participants returned unused cigarettes and were provided a supply to last until the next visit. To encourage the return of and prevent sharing of cigarettes, participants received in additional compensation the market value of the cigarettes returned. Smokers in the non-menthol group were asked to not smoke menthol cigarettes but to inform study staff if they did and that they would not be penalized for doing so. Since menthol from cigarettes cannot be differentiated from menthol in food products,16–18 payments for study visits were not contingent on biochemical verification of menthol abstinence. Participants were encouraged to call the quitline prior to their quit date for assistance with their cessation attempt but no specific instructions were provided regarding how to abstain from menthol cigarettes (for those in the non-menthol condition).
At each visit, tobacco diaries were collected, exhaled CO was measured using a Bedfont Micro+ Smokerlyzer and participants completed questionnaires (see below). Cotinine was assayed from urine collected at the baseline and week 4 visits.
Outcome Measures
Craving and withdrawal severity were assessed using the Minnesota Nicotine Withdrawal Scale (MNWS) and the Questionnaire of Smoking Urges (QSU). MNWS craving “over the last 24 hours” was scored by the “craving for cigarettes” item and withdrawal symptoms by the sum of the other seven items.19,20 From the QSU which asked about symptoms “right now,” factor 1 (reflecting an intention and desire to smoke), factor 2 (reflecting anticipation of relief from craving), and total score were calculated.21 A Motivation and Self-Efficacy Scale asked participants to rate how motivated, confident, effective, and effortful they felt to become abstinent from cigarettes “at this time.” 22 Perceived health risks (on a scale of 1–10) due to the tobacco products used were asked for nine health problems.23 Support for a ban was assessed on a 10-point scale in which the anchors were “not supportive” and “very supportive.” A modified Cigarette Evaluation Scale asking about cigarettes smoked during the past week was added partway through data collection and was completed at both the baseline and week 4 visit by 36 participants. From this questionnaire scores were calculated for satisfaction, psychological reward, aversion, and craving reduction subscales.24 From urine samples at the baseline and week 4 visit, total cotinine concentrations were measured which is reported normalized per milligram creatinine.25
Statistical Analysis
Randomization assignments were generated by computerized pseudo-random number generation using permuted blocks of 4 or 6, with 1:1 allocation to menthol or non-menthol cigarettes, and stored in a Research Electronic Data Capture (REDCap) database. Research staff accessed the next assignment prior to each participant’s baseline visit.
Participants who attended the baseline visit and therefore were informed of their randomization assignment were included in the analysis. Outcomes were analyzed using correlated data models that included multiple observations per participant. For this analysis, only the pre-quit visits were modeled. The primary analysis included the week 0, 1, 2, and 4 visits. Fixed effects were included for randomization group, visit, and baseline measurement of the outcome variable. The primary comparison of interest was in estimating the average group difference over all post-baseline visits. An interaction effect of group and visit was additionally included in a separate model with the results noted if the interaction p value is <0.05. Cigarettes per day were modeled using generalized estimating equations with a Poisson error distribution and autoregressive (AR1) correlation structure. Other secondary outcomes were modeled using generalized linear mixed models with a random subject intercept. Exhaled CO and cotinine were log-transformed.
Since participants were instructed to quit on either the day prior to or the day of their week 4 visit (depending on their preference), outcomes measures of interest could be affected by short-term abstinence either directly (ie, exhaled CO, craving severity, withdrawal symptom severity, urge to smoke) or indirectly (eg, successful short-term abstinence could impact ratings on the confidence in ability to quit measure). A sensitivity analysis was therefore conducted in which only the week 0, 1, and 2 visits were included, for all outcomes (except support for a menthol ban which was not measured at weeks 1 and 2), using the same models as the primary analysis. An additional sensitivity analysis for cigarettes per day was performed to analyze the potential effects of missing data by assuming pre-baseline smoking amount when amount smoked was missing. Finally, we conducted a post hoc analysis of the interaction of sex with randomized cigarette type for all outcomes.
Within-subject changes in each outcome from baseline to week 4 were assessed with paired mean differences and t-confidence intervals (CIs).
Analyses were conducted using R software, version 3.4, primarily using the survival, geepack, and lme4 code packages.26–29
Results
Of 122 smokers who completed the baseline visit, 60 were randomized to continue smoking menthol and 62 to switch to non-menthol cigarettes for the month prior to their quit attempt. Of these, 93% (n = 114) completed the week 1 visit, 93% (n = 113) completed the week 2 visit, and 88% (n = 107) completed the entire 4-week pre-quit period (54 randomized to menthol and 53 randomized to non-menthol). Mean (SD) age at time of enrollment was 47 (10) for those randomized to continue smoking menthol cigarettes and 45 (11) for those assigned to switch to non-menthol cigarettes. In both groups 37% of participants were female. A total of 13 participants initiated their quit attempt on the day before their week 4 visit (n = 5 among the menthol group; n = 8 among the non-menthol group) whereas 69 initiated their quit attempt on the day of their week 4 visit (n = 36 among the menthol group; n = 33 among the non-menthol group). The 25 remaining participants initiated their quit attempt at an earlier (n = 10) or later (n = 15) date. Of those who initiated their quit attempt at an earlier time, only five did so more than 3 days early and of those who initiated their quit attempt at a later date all but 2 did so only 1 day late.
Participants reported that during the pre-cessation period, 90% of cigarettes smoked among those assigned to non-menthol and 99% of cigarettes smoked among those assigned to menthol cigarettes were consistent with their assignment (see left panel of Figure 1). The number of cigarettes smoked daily (menthol and non-menthol combined) over the study period was modestly lower in those randomized to the non-menthol versus menthol group with those in the non-menthol group smoking at about 0.86 times the rate of those in the menthol group (95% CI: 0.76, 0.98; p = .02) (see right panel of Figure 1). The sensitivity analyses (imputing missing smoking levels) demonstrated similar results, with a mean ratio of cigarettes smoked of 0.89. Concentrations of biomarkers of exposure (ie, exhaled CO, urinary cotinine) were similar in both groups (Table 1, Supplementary Table).
Figure 1.
Left panel: mean (SD) of the number of menthol cigarettes and non-menthol cigarettes smoked per day in those randomized to continue smoking menthol cigarettes or switch to non-menthol cigarettes. Right panel: mean (SD) of total number of cigarettes smoked per day in those randomized to continue smoking menthol cigarettes or switch to non-menthol cigarettes.
Table 1.
Raw Mean (SD) of Smoking Biomarkers and Subjective Measures Reported Between the Baseline Visit and the Week 4 Visit
| Measure | Menthol group | Non-menthol group | Non-menthol vs. menthol | ||||||
|---|---|---|---|---|---|---|---|---|---|
| Baseline | Week 1 | Week 2 | Week 4 | Baseline | Week 1 | Week 2 | Week 4 | Mean (95% CI) | |
| Smoking biomarkers | |||||||||
| Exhaled CO (ppm) | 15.3 (8.1) | 14.2 (8.8) | 13.4 (6.7) | 14.2 (7.9) | 15.3 (7.8) | 14.1 (8.1) | 14.4 (6.9) | 12.4 (8.7) | GMRb: 0.92 (0.80, 1.1) |
| Urinary cotinine (ng/mg creatinine) | 2105 (1250) | — | — | 2096 (1419) | 2145 (1199) | — | — | 2221 (1564) | GMRb: 1.06 (0.77, 1.45) |
| Craving and withdrawal symptoms | |||||||||
| Craving (from MNWS) | 2.8 (1.0) | 2.5 (1.2) | 2.0 (1.1) | 1.9 (1.1) | 2.7 (0.80) | 2.2 (1.1) | 2.2 (1.1) | 1.6 (1.0) | −0.11 (−0.40, 0.18)a |
| Withdrawal (from MNWS) | 7.0 (6.3) | 8.2 (6.6) | 7.6 (6.4) | 6.4 (6.0) | 6.7 (6.0) | 7.4 (5.9) | 6.1 (5.8) | 4.9 (4.7) | −1.29 (−2.6, −0.01) |
| QSU factor 1 | 72.1 (16.2) | 67.4 (17.9) | 64.6 (16.8) | 58.9 (17.8) | 69.2 (20.5) | 66.5 (20.0) | 61.4 (19.7) | 51 (20.0) | −2.69 (−7.45, 2.07) |
| QSU factor 2 | 35.6 (14.8) | 31.7 (14.1) | 30.8 (14.4) | 28.3 (12.0) | 35 (15.1) | 31 (14.2) | 28.6 (15.8) | 25.3 (15) | −2.1 (−5.43, 1.15) |
| QSU total score | 133 (32.4) | 123 (33.8) | 119 (29.6) | 109 (30.3) | 129 (38.7) | 121 (36.6) | 111 (37.0) | 95 (38.6) | −6.99 (−15.42, 1.44) |
| Perceived health risk | |||||||||
| Lung cancer | 7.7 (2.7) | 6.8 (3.2) | 6.9 (3.1) | 7.2 (3.1) | 8.0 (2.3) | 6.9 (3.2) | 6.8 (3.2) | 6.9 (3.4) | −0.28 (−1.15, 0.59) |
| Emphysema | 7.2 (3.0) | 6.2 (3.4) | 6.5 (3.3) | 7.0 (2.9) | 7.3 (2.6) | 6.2 (3.5) | 6.5 (3.2) | 6.5 (3.3) | −0.21 (−1.05, 0.63) |
| Bronchitis | 7.4 (3.0) | 6.8 (3.4) | 6.8 (3.2) | 7.2 (3.0) | 7.2 (2.6) | 6.5 (3.1) | 6.5 (3.2) | 6.4 (3.5) | −0.39 (−1.15, 0.37) |
| Other cancers | 6.8 (3.1) | 6.1 (3.3) | 6.4 (3.2) | 6.9 (3.0) | 7.1 (2.7) | 6.3 (3.5) | 6.4 (3.4) | 6.3 (3.5) | −0.55 (−1.30, 0.21) |
| Heart disease | 7.3 (3.2) | 6.7 (3.4) | 6.7 (3.1) | 7.3 (3.0) | 7.3 (2.8) | 6.8 (3.3) | 6.8 (3.2) | 6.4 (3.6) | −0.31 (−1.05, 0.42)a |
| Risk of addiction | 8.7 (2.4) | 8.0 (3.0) | 8.0 (3.1) | 8.4 (2.7) | 8.3 (2.7) | 6.7 (3.6) | 7.1 (3.3) | 6.7 (3.5) | −1.38 (−2.37, −0.39) |
| Stroke | 6.8 (3.2) | 6.3 (3.2) | 6.4 (3) | 7.0 (3.0) | 7.1 (2.9) | 6.1 (3.3) | 6.3 (3.4) | 6.4 (3.5) | −0.66 (−1.53, 0.21) |
| Mouth cancer | 6.4 (3.4) | 6.7 (3.3) | 6.3 (3.2) | 7.0 (3.0) | 6.7 (3.0) | 6.1 (3.4) | 6.3 (3.4) | 6.1 (3.7) | −0.84 (−1.66, −0.03) |
| Tooth loss | 6.1 (3.4) | 6.3 (3.5) | 6.2 (3.3) | 6.9 (3.1) | 6.3 (3.3) | 6.1 (3.6) | 6.4 (3.4) | 6.1 (3.7) | −0.60 (−1.51, 0.32) |
| Motivation to quit | |||||||||
| Motivation to quit | 7.8 (2.2) | 7.6 (2.2) | 7.8 (1.9) | 8.3 (2.0) | 8.0 (2.3) | 8.0 (2.1) | 8.1 (2.0) | 8.7 (2.1) | 0.34 (−0.12, 0.81) |
| Confidence in ability to quit | 6.5 (2.5) | 6.8 (2.0) | 6.7 (2.4) | 7.5 (2.2) | 7.2 (2.3) | 7.1 (2.2) | 7.6 (2.2) | 8.2 (2.3) | 0.39 (−0.16, 0.93) |
| Effectiveness of quitting skills | 6.2 (2.3) | 6.1 (2.1) | 6.7 (2.2) | 7.1 (2.7) | 6.4 (2.6) | 6.4 (2.5) | 7.4 (2.0) | 7.7 (2.6) | 0.56 (0.02, 1.10) |
| Effort put toward quitting | 9.0 (1.9) | 8.8 (1.8) | 8.8 (1.9) | 8.9 (1.9) | 8.8 (2.1) | 8.6 (1.8) | 8.8 (1.8) | 9.0 (1.8) | 0.07 (−0.43, 0.57) |
| Cigarette Evaluation Scale | |||||||||
| Satisfaction | 4.3 (1.3) | 3.9 (1.6) | 3.6 (1.8) | 3.7 (1.8) | 4.5 (1.3) | 3.5 (1.5) | 3.8 (1.3) | 3.8 (1.4) | −0.14 (−0.74, 0.45) |
| Psychological reward | 3.3 (1.6) | 3.2 (1.6) | 3.0 (1.7) | 3.0 (1.4) | 3.7 (1.4) | 2.9 (1.1) | 3.2 (1.3) | 3.0 (1.4) | −0.25 (−0.72, 0.22) |
| Aversion | 2.0 (1.0) | 1.9 (1.0) | 2.1 (1.0) | 2.2 (1.2) | 2.2 (1.4) | 1.7 (0.77) | 2.1 (1.0) | 2.2 (1.4) | −0.22 (−0.69, 0.25) |
| Craving reduction | 5.1 (1.8) | 4.5 (2.1) | 4.6 (2.0) | 3.9 (2.4) | 5.2 (1.7) | 4.0 (2.1) | 4.5 (1.9) | 4.5 (2.2) | −0.15 (−0.94, 0.64) |
| Support for menthol ban | |||||||||
| Support for menthol ban | 5.5 (3.4) | 5.9 (3.3) | 5.7 (3.4) | 6.3 (3.3) | 0.22 (−0.78, 1.21) |
In the comparison between groups for smoking biomarkers, geometric mean ratio (95% CI) is indicated; for all other measures, mean difference between groups (95% CI) is indicated. These represent the average difference between randomized groups over weeks 1–4, adjusting for baseline values, using a linear mixed model (one linear mixed model per measure/outcome). Shaded cells are those in which the 95% confidence interval does not cross zero (or one for the smoking biomarkers). CI = confidence interval, CO = carbon monoxide, MNWS = Minnesota Nicotine Withdrawal Scale, QSU = Questionnaire of Smoking Urges.
aGroup by week interaction: p = .03.
bGeometric mean ratio.
Withdrawal symptom severity over the four visits was lower in the non-menthol group relative to the menthol group (mean difference −1.29; 95% CI: −2.6 to −0.01; p = .05) although the difference was not statistically significant when the week 4 visit was excluded (Table 1, Supplementary Table). Craving as assessed by either the MNWS or the QSU decreased in both groups over the 4-week period (Table 2). Overall craving severity (as assessed by either measure) was similar between groups over both the 4- and 2-week periods (Table 1, Supplementary Table).
Table 2.
Paired Mean Difference (95% CI) Between the Week 4 Visit and Baseline Visit of Assessed Measures Analyzed Separately in the Group Randomized to Continue Smoking Menthol Cigarettes and in Those Randomized to Non-menthol Cigarettes
| Measure | Menthol group | Non-menthol group | ||
|---|---|---|---|---|
| n | Paired mean difference (95% CI) | n | Paired mean difference (95% CI) | |
| Smoking biomarkers | ||||
| Exhaled CO (ppm) | 54 | −1.0 (−3.0, 1.0) | 53 | −2.3 (−4.5, −0.2) |
| Urinary cotinine (ng/mg creatinine) | 53 | 15.5 (−329.1, 360.0) | 52 | 44.2 (−275.2, 363.6) |
| Subjective measures | ||||
| Craving (from MNWS) | 53 | −0.9 (−1.3, −0.5) | 53 | −1.1 (−1.4, −0.8) |
| Withdrawal (from MNWS) | 53 | −0.3 (−1.7, 1.2) | 53 | −2.0 (−3.8, −0.3) |
| QSU factor 1 | 53 | −13.6 (−19.2, −7.9) | 53 | −18.4 (−24.6, −12.3) |
| QSU factor 2 | 53 | −7.6 (−11.3, −3.8) | 53 | −10.9 (−14.6, −7.3) |
| QSU total score | 53 | −24.1 (−34.0, −14.2) | 53 | −35.8 (−46.6, −25.1) |
| Perceived health risk | ||||
| Lung cancer | 53 | −0.7 (−1.4, −0.1) | 53 | −1.1 (−1.9, −0.3) |
| Emphysema | 53 | −0.3 (−0.9, 0.2) | 53 | −1.0 (−1.9, −0.1) |
| Bronchitis | 53 | −0.4 (−0.9, 0.1) | 53 | −1.0 (−1.8, −0.2) |
| Other cancers | 53 | −0.2 (−0.8, 0.5) | 53 | −1.1 (−1.8, −0.3) |
| Heart disease | 53 | −0.3 (−0.8, 0.3) | 53 | −1.1 (−1.8, −0.4) |
| Risk of addiction | 53 | −0.3 (−1.1, 0.4) | 53 | −1.7 (−2.7, −0.7) |
| Stroke | 53 | 0.1 (−0.6, 0.7) | 53 | −0.9 (−1.8, −0.1) |
| Mouth cancer | 53 | 0.4 (−0.3, 1.1) | 53 | −0.9 (−1.7, −0.1) |
| Tooth loss | 53 | 0.6 (−0.2, 1.3) | 53 | −0.5 (−1.4, 0.5) |
| Motivation to quit | ||||
| Motivation to quit | 53 | 0.6 (0.0, 1.2) | 53 | 0.8 (0.2, 1.4) |
| Confidence in ability to quit | 53 | 1.1 (0.5, 1.6) | 53 | 1.1 (0.4, 1.8) |
| Effectiveness of quitting skills | 53 | 0.9 (0.3, 1.6) | 53 | 1.4 (0.7, 2.1) |
| Effort put toward quitting | 53 | 0.0 (−0.6, 0.6) | 53 | 0.2 (−0.4, 0.8) |
| Cigarette Evaluation Scale | ||||
| Satisfaction | 18 | −0.6 (−1.1, −0.0) | 18 | −0.6 (−1.2, −0.0) |
| Psychological reward | 18 | −0.3 (−0.8, 0.1) | 18 | −0.7 (−1.2, −0.2) |
| Aversion | 18 | 0.4 (−0.3, 1.0) | 18 | −0.1 (−1.0, 0.8) |
| Craving reduction | 18 | −1.1 (−2.0, −0.1) | 18 | −0.6 (−1.6, 0.4) |
| Support for menthol ban | ||||
| Support for menthol ban | 53 | 0.4 (−0.5, 1.3) | 53 | 0.5 (−0.3, 1.2) |
Shaded cells are those in which the 95% confidence interval does not cross zero. n is the number of participants who completed the respective measure for both the baseline and week 4 visits. CI = confidence interval, CO = carbon monoxide, MNWS = Minnesota Nicotine Withdrawal Scale, QSU = Questionnaire of Smoking Urges.
Over the 4-week period, the non-menthol group averaged modestly lower scores on all measures of perceived risk, with perceived risk of addiction (mean difference −1.38; 95% CI: −2.37 to −0.39; p = .01) and perceived risk of mouth cancer (mean difference −0.84; 95% CI: −1.66 to −0.03; p = .05) having the largest differences and the only measures for which the difference reached statistical significance (Table 1). Whereas in those randomized to menthol cigarettes, there were generally small differences between baseline and week 4 in perceived risk, in those who switched to non-menthol cigarettes perceived risk for many diseases decreased significantly over the 4-week period (Tables 1 and 2). In both groups, motivation to quit, confidence in ability to quit and effectiveness of quitting skills all increased between the baseline and week 4 visit (Table 2). Those randomized to non-menthol reported higher perceived effectiveness of their skills for quitting smoking (mean difference 0.56; 95% CI: 0.02–1.10; p = .05) than those randomized to continue smoking menthol cigarettes with smaller differences in the other motivation and self-efficacy measures (Table 1). All scoring factors of the cigarette evaluation questionnaire were similar in both groups (Table 1). Results over a 2-week period in these measures were generally similar to those observed over the 4-week period (Supplementary Table). Support for a menthol ban was similar for both groups and remained largely unchanged in both groups between the baseline and week 4 visits with mean (SD) support (on a 1–10 scale) for the menthol group being 5.5 (3.4) at baseline versus 5.9 (3.3) at week 4 and among those in the non-menthol group 5.7 (3.4) versus 6.3 (3.3) at baseline and week 4, respectively.
Overall, few differences were found in an analysis evaluating sex × group interactions with significant differences observed in only two of the subjective measures we assessed. In the aversion subscale of the Cigarette Evaluation Scale, baseline-adjusted scores in women averaged 0.65 points lower than males in the menthol group versus 0.32 points higher in the non-menthol group (total difference = 0.97 [95% CI: 0.08, 1.86]). In the motivation to quit measures, baseline-adjusted scores in women averaged 0.29 points lower than males in the menthol group versus 0.69 points higher in the non-menthol group (total difference = 0.98 [95% CI: 0.04,1.92]).
Discussion
This study found that when African American smokers of menthol cigarettes switched to non-menthol cigarettes the number of cigarettes smoked decreased. Although there were few differences between groups in most measures, this study did find that withdrawal symptom severity was modestly lower and perceived effectiveness of quitting skills was modestly higher in those switching to non-menthol cigarettes compared with those who continued to smoke menthol cigarettes. Even among the group randomized to abstain from menthol cigarettes, support for a menthol ban did not decrease during the course of the study. These results suggest that were menthol cigarettes no longer available, those that switch to non-menthol cigarettes would not change their smoking behavior in a way that is likely to be more hazardous, with some indicators suggesting that there may be some benefit.
Our findings demonstrating that after switching to non-menthol cigarettes, smoking decreased and aspects of motivation or self-efficacy to quit increased are consistent with other studies showing similar results.12,13 However, the extent to which smoking decreased in the current study was modest and measures of biomarkers of exposure (ie, exhaled CO, urinary cotinine) were similar between groups. Other studies similarly did not find changes in at least some biomarkers of exposure when examining the effects of switching menthol smokers to non-menthol cigarettes suggesting that any differences in these measures are likely to be modest or that there may be changes in smoking topography occurring.12,13,30,31 Differences among the studies in factors such as participant demographics, the extent to which participants were motivated to quit smoking and in experimental design of the study (eg, crossover vs. parallel) make directly comparing the studies difficult.
Studies assessing perceived health risks associated with menthol (vs. non-menthol) cigarettes have reported inconsistent results with some reporting menthol cigarettes as perceived to have greater risks and others reporting that menthol cigarettes are perceived as equally or less harmful.12,32–36 The implications of our findings that perceived risk of disease decreases after switching to non-menthol cigarettes are not clear and suggest that were a menthol ban to be enacted it would be important to educate smokers that switching to non-menthol cigarettes is not an effective method by which to decrease tobacco-related health risks. Our study found moderate support for a menthol ban which did not decrease among those randomized to either condition suggesting that were a menthol ban enacted, the relatively strong support, particularly among African Americans, that has been reported for a ban is not likely to decrease after it is enacted.37–39 Interestingly, our study found that both groups had similar ratings on the Cigarette Evaluation Scale which is in contrast to studies that found that menthol cigarette smokers rated non-menthol cigarettes lower in at least some subjective measures than menthol cigarettes.13,30,31 Our findings of sex × group interactions in motivation to quit and extent to which the cigarettes were rated as aversive should be considered preliminary since this was a secondary analysis and we did not see differences in the other subjective measures assessed.
There are several limitations in the current study. A primary limitation is that since participants in this study had already committed to a smoking quit date, these data may not be generalizable to those who are not interested in quitting or have not yet set a quit date. Nonetheless, these data suggest that were a ban on menthol enacted it would likely not adversely affect menthol smokers who were already planning on quitting. This is consistent with a study reporting that in a focus group of African American smokers, those who were contemplating cessation indicated that a menthol ban might encourage a reduction in the amount smoked and prompt attempts to quit entirely.34 Additional limitations are that the easy availability of menthol cigarettes resulted in incomplete substitution in the non-menthol group and that the study did not have a way of verifying the extent to which menthol cigarettes were smoked in those randomized to the non-menthol group. Although these limitations could be expected to attenuate any observed effects on smoking behavior, this cannot be assumed. Furthermore, since non-menthol cigarettes were provided, it is possible that changes in tobacco use following an actual menthol ban would be different than observed in this study, particularly since a ban that only includes cigarettes would leave other menthol flavored tobacco products (such as e-cigarettes) available to menthol cigarette smokers. It is not known how the availability of characterizing menthol flavor in these other products would influence overall tobacco use patterns and research in this area is needed. It is also possible that were menthol cigarettes banned, non-menthol cigarettes would be marketed so as to make them more appealing to former menthol smokers and thereby affect the measures assessed in this study.40 Additionally, it is possible that differences in nicotine content or other factors between participants’ usual brand cigarettes and those that were selected in the non-menthol arm of the study impacted the results.41
In summary, this study found that African American menthol cigarette smokers when switching to non-menthol cigarettes modestly decreased the number of cigarettes smoked and reported lower withdrawal symptom severity and higher perceived effectiveness of quitting skills compared with those who continue to smoke menthol cigarettes. The differences between groups were modest; however, they were in a direction suggesting that current menthol smokers would not adjust their behavior in a way that is likely to be more hazardous, with some measures indicating possible benefit.
Supplementary Material
A Contributorship Form detailing each author’s specific involvement with this content, as well as any supplementary data, are available online at https://academic.oup.com/ntr.
Funding
This work was supported by ClearWay Minnesota grant # 2014-0010 and grants # UL1TR000114 and UL1TR002494 from the National Center for Advancing Translational Sciences of the National Institutes of Health. The content is solely the responsibility of the authors and does not necessarily represent the official views of the funding agencies.
Declaration of Interests
Dr Okuyemi has received administrative assistant support from Pfizer for the submission of an unrelated manuscript.
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