Nicotine blood levels and short-term smoking reduction with an electronic nicotine delivery system.

OBJECTIVES: To evaluate nicotine delivery from the NJOY® King Bold Electronic Nicotine Delivery System (ENDS) and its short-term potential for smoking reduction or cessation. METHODS: One week of ad libitum use was followed by measurements of plasma nicotine, heart rate, and craving and withdrawal after 12 hours of nicotine abstinence in 25 adult smokers not interested in quitting. RESULTS: After 5 minutes of use, blood nicotine levels increased by a mean of 3.5 ng/mL (p < .001), heart rate increased, and craving was reduced by 55%. Cigarettes per day were reduced by 39% during the test week, and perceptions of use for reduction or cessation were positive. CONCLUSIONS: The NJOY® King Bold ENDS delivers nicotine and led to short-term smoking reduction.

Effects of sustained-release bupropion among persons interested in reducing but not quitting smoking.

PURPOSE: To determine whether sustained-release bupropion promotes smoking reduction leading to smoking cessation among persons who wish to reduce their amount of smoking, but who are unwilling to quit or who perceive themselves as being unable to quit. METHODS: Current smokers were assigned randomly to receive either sustained-release bupropion (150 mg twice daily) or matching placebo. During an initial 6-month smoking reduction phase, those who were willing to quit entered a 7-week cessation phase, during which study medication was continued. RESULTS: Four-week continuous abstinence rates were 14% (41/295) in the bupropion group and 8% (25/299) in the placebo group (P = 0.02) during treatment. However, this benefit did not continue after treatment was stopped; subsequent continuous abstinence rates were 7% (20/295) in the bupropion group and 5% (16/299) in the placebo group (P = 0.50). Similar proportions of subjects entered the cessation phase in both treatment groups (38% [n = 113] of those in the bupropion group and 34% [n = 101] of those in the placebo group), although the time until a cessation attempt was shorter for those taking bupropion (median, 64 days vs. 118 days, P = 0.008). The extent of smoking reduction (measured by urinary cotinine concentrations) among the 327 subjects who did not enter the cessation phase was significantly greater (P <0.05) in those treated with bupropion during the reduction treatment phase, but not during the month 12 follow-up visit (P = 0.25). CONCLUSION: Sustained-release bupropion, when used in smokers initially not willing to make a cessation attempt, can help sustain smoking reduction while subjects are on active medication, reduce the time until the next cessation attempt, and increase short-term abstinence rates. However, these benefits were modest and not sustained after bupropion was discontinued.

Targeting smokers at increased risk for relapse: treating women and those with a history of depression.

Some studies have shown that female smokers and smokers with a history of depression have an increased risk of relapse following smoking cessation treatment. This study examined the efficacy of bupropion sustained-release (SR) and the nicotine patch for smoking cessation in subgroups of smokers at possible risk for relapse. Data for this study were from a previously published randomized, double-blind, placebo-controlled clinical trial in which 893 smokers were randomized to four treatment conditions: placebo tablet + placebo patch, placebo tablet + 21 mg/24-hr nicotine patch, 300mg bupropion SR + placebo patch, and 300mg bupropion SR + 21 mg/24-hr nicotine patch. Study medication continued for 8 weeks after the quit day; brief individual cessation counseling was provided during weekly clinic visits. In comparison to the placebo tablet, bupropion SR approximately tripled 1-year non-smoking rates among women and previously depressed individuals. In contrast, the nicotine patch did not significantly improve cessation rates for any group. We conclude that bupropion SR is a first-line treatment for smoking that has the potential to benefit all smokers, especially women and the previously depressed.

Relations of cotinine and carbon monoxide to self-reported smoking in a cohort of smokers and ex-smokers followed over 5 years.

We describe the persistence of discrepancies between biochemical measures of smoking and self-reported smoking status in a cohort of clinical trial participants across 5 years. The Lung Health Study, a randomized trial in 10 clinical centers in North America, enrolled 3923 participants in smoking intervention and 1964 in usual care in 1987 and 1988. Smoking status was assessed at baseline and at five annual follow-up visits by self-report, salivary cotinine and expired-air carbon monoxide. Compared to self-report, sensitivity and specificity of cotinine and carbon monoxide were similar across 5 years. Evidence of error in self-reports of quitting smoking persisted across 5 years, although it declined over time. Multivariate models confirmed that self-report bias was characteristic of the early years in the study. Significant covariates differed between cotinine and carbon monoxide models. When cotinine was used for verification, about half of the individuals in the smoking intervention group with self-report bias at the first year continued to exhibit bias for 5 years. In absolute terms, the errors associated with measurement were small, but they persisted over 5 years. Some differences appeared to be related to the distinction that carbon monoxide verification was immediate, while cotinine verification was deferred.

Impact of prior nicotine replacement therapy on smoking cessation efficacy.

OBJECTIVE: To examine previous use of nicotine replacement therapy (NRT) on the smoking-cessation efficacy of bupropion sustained release (SR). METHODS: Secondary analysis of a parallel-group, randomized, double-blind, placebo-controlled study. Smokers who had, based on self-report, no previous history of NRT (N = 453) or who had used NRT at least once (N = 440) were randomized to receive placebo, bupropion SR, nicotine transdermal system (NTS), or a combination of bupropion SR and NTS. RESULTS: Bupropion SR showed similar efficacy in participants with or without previous use of NRT. CONCLUSION: Bupropion SR is effective in promoting smoking abstinence regardless of prior NRT use.