Dataset Information

A randomized clinical trial of nicotine lozenge for smokeless tobacco use.

ABSTRACT:

Introduction

Smokeless tobacco (ST) use is associated with adverse health consequences, and effective treatments are needed. Pilot data suggest that 4-mg nicotine lozenge decreases tobacco craving and nicotine withdrawal symptoms among ST users.

Methods

We conducted a randomized, placebo-controlled multicenter clinical trial to evaluate the efficacy of 12 weeks of 4-mg nicotine lozenge for ST use.

Results

We randomized 270 participants (136 active lozenge, 134 placebo). No significant differences were observed between the groups in biochemically confirmed all tobacco abstinence rates at Week 12 (36% lozenge vs. 27.6% placebo; odds ratio [OR] 1.5, 95% CI 0.7-2.1; p = .138). However, the 4-mg nicotine lozenge increased self-reported all tobacco abstinence (44.1% vs. 29.1%; OR 1.9, 95% CI 1.2-3.2; p = .011) and self-reported ST abstinence (50.7% vs. 34.3%; OR 2.0, 95% CI 1.2-3.2; p = .013) compared with placebo at the end of treatment (Week 12). Following target quit date (TQD), nicotine withdrawal symptoms decreased significantly with time (time effect = -.022 per day, SE = .003; p < .001) and was significantly lower for the active lozenge (treatment effect = -.213, SE = .071; p = .003). Tobacco craving also decreased significantly following TQD (time effect = -.071, SE = .006; p < .001) and was lower for the active nicotine lozenge (treatment effect = -.452, SE = .164; p = .006).

Discussion

The 4-mg nicotine lozenge increased self-reported but not biochemically confirmed tobacco abstinence rates at 3 months. The use of the 4-mg nicotine lozenge is associated with decreased nicotine withdrawal symptoms and tobacco craving.

SUBMITTER: Ebbert JO

PROVIDER: S-EPMC2784490 | biostudies-literature | 2009 Dec

REPOSITORIES: biostudies-literature

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Publications

A randomized clinical trial of nicotine lozenge for smokeless tobacco use.

Ebbert Jon O JO Severson Herbert H HH Croghan Ivana T IT Danaher Brian G BG Schroeder Darrell R DR

Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco 20091030 12

<h4>Introduction</h4>Smokeless tobacco (ST) use is associated with adverse health consequences, and effective treatments are needed. Pilot data suggest that 4-mg nicotine lozenge decreases tobacco craving and nicotine withdrawal symptoms among ST users.<h4>Methods</h4>We conducted a randomized, placebo-controlled multicenter clinical trial to evaluate the efficacy of 12 weeks of 4-mg nicotine lozenge for ST use.<h4>Results</h4>We randomized 270 participants (136 active lozenge, 134 placebo). No ...[more]

PMID: 19880578

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Project description:IntroductionNicotine replacement medications are moderately effective in increasing quit rates. However, some smokers reject such aids, suggesting the value of considering alternative options. Snus, a smokeless tobacco product with low nitrosamine content, could offer an alternative. This study compared smoking cessation rates for snus, with and without information about reduced risk relative to smoking, with a nicotine lozenge (without relative risk information).MethodsA randomized, open-label, multicenter clinical trial was performed with 649 smokers, aged 21 to 65, who smoked at least 10 cigarettes per day for the past year and who were motivated to quit smoking. Participants were followed for up to 12 months and were provided no counseling or support. Smoking cessation was analyzed as continuous smoking abstinence (no smoking following quit date) and repeated point prevalence abstinence (no smoking within past 7 days).ResultsAbstinence rates did not differ significantly between snus and the nicotine lozenge-continuous abstinence did not differ at any time point, and point prevalence rates differed only at month 3, when the lozenge group showed higher abstinence rates (17.4%) than either of the two snus groups (snus alone: 8.7%; snus plus information: 10.1%). Large percentages of participants used the products during the treatment period. Providing relative risk information to snus users did not affect snus use. The amount of use did not predict subsequent outcome. Adverse events were reported at similar rates across the three groups.ConclusionsSmoking cessation rates were comparable between snus and a nicotine lozenge, but success rates in this trial were low.ImplicationsThis randomized trial of the nicotine lozenge, snus, or snus plus information on the relative risks of smokeless tobacco versus smoking found comparable but low smoking cessation rates for all three groups at weeks 12, 26, and 52. The one-time provision of relative risk information did not lead to greater snus use among those provided the information, suggesting no effect for this brief intervention.

Project description:IntroductionPartner behaviors and attitudes can motivate or undermine a tobacco user's cessation efforts. We developed a multimedia intervention, UCare (Understanding-CAring-REspect) for women who wanted their male partner to quit smokeless tobacco (ST), based on perceived partner responsiveness-the empirically based theory that support is best received when the supporter conveys respect, understanding, and caring.MethodsOne thousand one hundred three women were randomized to receive either immediate access to the UCare website and printed booklet (Intervention; N = 552), or a Delayed Treatment control (N = 551). We assessed supportive behaviors and attitudes at baseline and 6-week follow-up, and the ST-using partner's abstinence at 6 weeks and 7.5 months (surrogate report).ResultsFor partners of women assigned to Intervention, 7.0% had quit all tobacco at 7.5 months, compared with 6.6% for control (χ2 (1, n = 1088) = .058, p = .810). For partners of women completing the intervention, 12.4% had quit all tobacco at 7.5 months, compared with 6.6% for Delayed Treatment (χ2 (1, n = 753) = 6.775, p = .009). A previously reported change in responsiveness-based behaviors and instrumental behaviors at 6 weeks mediated 7.5-month cessation, and change in responsiveness-based attitudes mediated the change in responsiveness-based behaviors, indirectly increasing cessation.ConclusionsA responsiveness-based intervention with female partners of male ST users improved supportive attitudes and behaviors, leading to higher cessation rates among tobacco users not actively seeking to quit. The study demonstrates the potential for responsiveness as a basis for effective intervention with supporters. This approach may reach tobacco users who would not directly seek help.ImplicationsThis study demonstrates the value of a responsiveness-based intervention (showing respect, understanding, and caring) in training partners to provide support for a loved one to quit ST. In a randomized clinical trial, 1,103 women married to or living with a ST user were randomized to receive the UCare-ChewFree intervention (website + booklet) or a Delayed Treatment control. Women completing the intervention were more likely to improve their behaviors and attitudes, and change in behaviors and attitudes mediated cessation outcomes for their partners, who had not enrolled in the study and may not have been seeking to quit.Trial registrationClinicalTrials.gov NCT01885221.

Project description:BackgroundIn central Australia, Aboriginal women use wild tobacco plants, Nicotiana spp. (locally known as pituri) as a chewed smokeless tobacco, with this use continuing throughout pregnancy and lactation. Our aim was to describe the biological concentrations of nicotine and metabolites in samples from mothers and neonates and examine the relationships between maternal self-reported tobacco use and maternal and neonatal outcomes.MethodsCentral Australian Aboriginal mothers (and their neonates) who planned to birth at the Alice Springs Hospital (Northern Territory, Australia) provided biological samples: maternal blood, arterial and venous cord blood, amniotic fluid, maternal and neonatal urine, and breast milk. These were analysed for concentrations of nicotine and five metabolites.ResultsA sample of 73 women were enrolled who self-reported: no-tobacco use (n = 31), tobacco chewing (n = 19), or smoking (n = 23). Not all biological samples were obtained from all mothers and neonates. In those where samples were available, higher total concentrations of nicotine and metabolites were found in the maternal plasma, urine, breast milk, cord bloods and Day 1 neonatal urine of chewers compared with smokers and no-tobacco users. Tobacco-exposed mothers (chewers and smokers) with elevated blood glucose had higher nicotine and metabolite concentrations than tobacco-exposed mothers without elevated glucose, and this was associated with increased neonatal birthweight. Neonates exposed to higher maternal nicotine levels were more likely to be admitted to Special Care Nursery. By Day 3, urinary concentrations in tobacco-exposed neonates had reduced from Day 1, although these remained higher than concentrations from neonates in the no-tobacco group.ConclusionsThis research provides the first evidence that maternal pituri chewing results in high nicotine concentrations in a wide range of maternal and neonatal biological samples and that exposure may be associated with adverse maternal and neonatal outcomes. Screening for the use of all tobacco and nicotine products during pregnancy rather than focusing solely on smoking would provide a more comprehensive assessment and contribute to a more accurate determination of tobacco and nicotine exposure. This knowledge will better inform maternal and foetal care, direct attention to targeted cessation strategies and ultimately improve long-term clinical outcomes, not only in this vulnerable population, but also for the wider population.Note to readersIn this research, the central Australian Aboriginal women chose the term 'Aboriginal' to refer to themselves, and 'Indigenous' to refer to the broader group of Australian First Peoples. That choice has been maintained in the reporting of the research findings.

Dataset Information

A randomized clinical trial of nicotine lozenge for smokeless tobacco use.

Introduction

Methods

Results

Discussion

Publications

A randomized clinical trial of nicotine lozenge for smokeless tobacco use.

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