Characteristics of selectors of nicotine replacement therapy.

OBJECTIVE: To assess differences in demographic and smoking characteristics between smokers who have and have not used nicotine replacement therapy (NRT). DESIGN: Mail survey of US smokers from a national research panel. PARTICIPANTS: Smokers 18 years and over who returned a survey on smoking (n = 9630). The sample was weighted to match the US smoker population on age and sex. MAIN OUTCOME MEASURES: Compared smokers who had/had not used NRT in a quit attempt (ever NRT use or over the counter (OTC) NRT use) on: demographic characteristics, nicotine dependence, history of craving and withdrawal, expected difficulty quitting, and self reported history of smoking related medical illness and psychopathology. RESULTS: NRT users (both ever-users and OTC users) were more likely to be older, male, and better educated. They were also heavier smokers, had experienced more craving and withdrawal upon quitting, and scored higher on measures of dependence. These differences were evident among light smokers, and remained even when smoking rate and time to first cigarette were controlled. CONCLUSION: Smokers who elect to use NRT differ from non-NRT users in ways that predispose them to failure in cessation. Controlling for smoking rate and time to first cigarette does not eliminate these differences, even among light smokers. These differences must be considered when comparing the effectiveness of NRT among samples of smokers who self select their treatment and are likely to bias such outcome comparisons.

The efficacy of computer-tailored smoking cessation material as a supplement to nicotine polacrilex gum therapy.

BACKGROUND: Standard, generic self-help materials have been largely ineffective as behavioral treatments for smoking cessation. In contrast, self-help programs tailored to the needs of specific smokers have shown promise in facilitating quitting. OBJECTIVE: To evaluate the incremental efficacy of the Committed Quitters Program (CQP), a set of computer-tailored materials offered to purchasers of nicotine polacrilex gum, compared with a briefuntailored user's guide and audiotape, both as supplements to nicotine replacement therapy. METHODS: We conducted a randomized, open-label trial with 3 parallel arms. Subjects were smokers who purchased 2- or 4-mg nicotine polacrilex gum and called the CQP toll-free enrollment line. Three thousand six hundred twenty-seven subjects consented to participate in 1 of 3 study arms: (1) those receiving the CQP materials (CQP group, n= 1,217), (2) those receiving CQP materials and an outbound telephone call (CQP + C group, n= 1,207); and (3) those receiving no supplemental intervention beyond the user's guide and audiotape that were prepackaged with the nicotine polacrilex gum (UG group, n= 1,203). Twenty-eight-day continuous abstinence rates were assessed by telephone interviews at 6 weeks and 10-week continuous rates at 12 weeks into treatment. RESULTS: Abstinence rates among respondents at the 6- and 12-week assessments were significantly higher for the CQP (36.2% and 27.6%) and CQP + C (35.5% and 27.3%) groups compared with the UG group (24.7% and 17.7%) at both intervals. The quit rates for the CQP and CQP + C groups were almost identical. CONCLUSIONS: The CQP proved to be an effective behavioral treatment, enhancing quit rates over and above nicotine replacement therapy and a brief untailored written guide and audiotape.

Comparative efficacy of 24-hour and 16-hour transdermal nicotine patches for relief of morning craving.

AIMS: To compare a transdermal nicotine patch designed for 24-hour wear with one designed for 16-hour wear for relief of craving and withdrawal, particularly in the morning hours. DESIGN: Smokers were randomly assigned to use one of two common patch regimens: NicoDerm/NiQuitin (24-hour wear, 21 mg nicotine) or Nicotrol/Nicorette (16-hour wear, 15 mg). In a double-dummy design, participants wore two patches during the day, one active, one placebo and one patch while sleeping. SETTING: A smoking cessation research clinic. PARTICIPANTS: Two hundred and forty-four smokers who suffered morning cravings. INTERVENTION: Two patch formulations approved and marketed for over-the-counter use in the US--NicoDerm CQ (labeled as 21 mg over 24 hours) and Nicotrol (labeled as 15 mg over 16 hours)--were each used according to its instructions. Smokers also received behavioral counseling. MEASUREMENTS: For a week of baseline and 2 weeks after quitting, smokers used palm-top computers to assess craving and withdrawal symptoms several times each day. FINDINGS: The 21 mg/24-hour patch yielded consistently better control of craving, not only during the morning hours, but throughout the day, and over the 2-week period of abstinence. Additionally, the 21 mg/24-hour patch yielded greater reductions in anxiety, irritability and restlessness. Smokers using the 21 mg/24-hour dosing regimen also experienced longer abstinence than those using the 15 mg/16-hour patch. CONCLUSIONS: These findings demonstrate that 24-hour dosing with a 21 mg patch affords superior relief of craving and withdrawal during the first 2 weeks of abstinence, when symptoms are at their peak, and when relapse is most likely. They confirm the importance of dosing parameters in nicotine replacement products.

The efficacy of computer-tailored smoking cessation material as a supplement to nicotine patch therapy.

The study evaluated the efficacy of the Committed Quitters Program (CQP), a computer-tailored set of printed behavioral support materials offered free to purchasers of NicoDerm CQ patches, as a supplement to the nicotine patch and the standard brief User's Guide (UG) and audiotape. Callers to the CQP enrollment were randomized to either CQP (n=1854) or just the UG (n=1829). Abstinence and use of program materials were assessed by telephone interview at 6 and 12 weeks (the latter falling 2 weeks after patch use was to be discontinued). Considering all respondents, abstinence rates did not differ significantly between the UG and CQP groups. As expected, among those who reported they used their assigned materials (80.1% of the sample) smokers who received CQP demonstrated higher quit rates at both 6 weeks (38.8% v. 30.7%) and 12 weeks (18.2% v. 11.1%), compared to the UG group. Among those who used it, the Committed Quitters Program proved to be an effective behavioral treatment, improving quit rates over nicotine replacement therapy and a brief untailored written guide and audiotape.

Smoker and ex-smoker reactions to cigarettes claiming reduced risk.

CONTEXT: The tobacco industry is introducing modified tobacco products claiming to reduce the risk of smoking (potential reduced exposure products, PREPs). If PREPs are perceived as safe, they may deter smokers from quitting and encourage re-initiation by smokers who have quit. OBJECTIVE: To assess smokers' and ex-smokers' perceptions of PREPs and the impact of PREP claims on interest in quitting (among smokers) or in resuming smoking (ex-smokers). DESIGN: A random-digit-dialled survey of US smokers and ex-smokers. We used Eclipse, a modified PREP cigarette, as an exemplar PREP. During the survey, the interviewer read risk reduction claims made for Eclipse by its manufacturer, assessing smokers' interest in quitting before and after the exposure. PARTICIPANTS: 1000 current cigarette smokers and 499 ex-smokers (300 quit within the last two years), over 18 years old. MAIN OUTCOME MEASURES: Perception of risk reduction from Eclipse; interest in using Eclipse; smokers' interest in quitting was assessed using a stage of change approach (pre- and post-exposure to claims). RESULTS: 91% of smokers thought Eclipse was safer than regular cigarettes. 24% believed Eclipse was completely safe. 57.4% of smokers were interested in using Eclipse; interest was greatest among smokers who were contemplating quitting. Exposure to Eclipse's claims was followed by reduced interest in quitting. Among all ex-smokers, interest in Eclipse was 6.2%, but interest was 15.2% among young adults (18-25 years) who had stopped smoking within two years. CONCLUSIONS: There is substantial risk that smokers will overinterpret reduced risk claims made for modified tobacco products. PREPs appeal to smokers who are contemplating quitting and exposure to reduced risk product claims appears to reduce smokers' readiness to quit. PREPs also appealed to young adults who had recently stopped smoking. Thus, reduced risk tobacco product claims can undermine adult cessation and youth prevention, possibly resulting in increased harm even if the products are less toxic.

Test of "Light" cigarette counter-advertising using a standard test of advertising effectiveness.

OBJECTIVE: To evaluate systematically the effectiveness of six advertising strategies (two message strategies presented in three different contexts) designed to promote smoking cessation by addressing smokers' misperceptions about Light cigarettes. DESIGN: Smokers viewed one of six, 30 second test television concept advertisements, which varied by message (one emphasising how the sensory effects of Lights can be deceptive, the other describing the effects of vent blocking) and by ad context (non-commercial public service announcement (PSA), promotion of unbranded nicotine replacement therapy (NRT), or promotion of branded NRT). The effectiveness of each advertisement was determined using a validated advertising testing system in which ads were viewed in the context of reviewing a pilot television programme. Response to ads is assessed through shifts in subject choices of products offered as prizes before and after viewing the test advertisements. Included among the possible prizes were cigarettes and various pharmacotherapies for smoking cessation. SUBJECTS: Daily smokers (n = 1890) of Regular (34%), Light (47%), and Ultra Light (19%) cigarettes recruited from eight US cities. MAIN OUTCOMES MEASURES: The primary outcome of interest was the shift away from cigarettes as the selected prize following exposure to the test advertisements. Secondary outcomes of interest included movement away from Light cigarettes and movement towards assisted quitting products. RESULTS: Smokers who saw the advertisement emphasising the sensory characteristics of Light cigarettes were more likely than subjects who saw the advertisement emphasising the effect of vent blocking to move away from cigarettes (OR = 1.97, 95% confidence interval CI 1.25 to 3.09; chi(2)(1) = 8.69, p = 0.003). Similarly, subjects who saw the advertisement framed as a PSA, rather than as a promotion for either a branded or unbranded NRT product, were also somewhat more likely to move away from cigarettes (OR = 1.51, 95% CI 0.94 to 2.40; chi(2)(1) = 2.97, p = 0.085). The effect was observed regardless of sex, age, or type of cigarette smoked. CONCLUSIONS: Addressing smokers' sensory perceptions of Light cigarettes and presenting this information in an impartial way is likely to be an effective communication strategy for counter-marketing Light cigarettes.