Higher Levels of a Cytotoxic Protein, Vaginolysin, in Lactobacillus-Deficient Community State Types at the Vaginal Mucosa.

Vaginolysin (VLY), a cytotoxic protein produced by Gardnerella vaginalis, may contribute to bacterial vaginosis. We observed that women with G. vaginalis, low levels of lactobacilli, history of vaginal douching, higher Nugent scores, and higher vaginal pH had increased VLY. Inflammatory markers were not highly expressed with increasing VLY. Vaginolysin's role in bacterial vaginosis warrants further evaluation.

Validation of the Glover-Nilsson Smoking Behavioral Questionnaire for the Portuguese population: a psychometric process.

OBJECTIVE: To validate the Portuguese version of the Glover-Nilsson Smoking Behavioral Questionnaire (GNSBQ). METHODS: This manuscript represents 2 studies. In the first, the free-translated Portuguese version of GNSBQ, currently in use, was administered to 124 healthy smokers for Confirmatory Factor Analysis (CFA). In the second, a forward-backward translation was developed to achieve a proper cultural and linguistic adaptation, which allowed creating a new Portuguese version of the GNSBQ. An Exploratory Factor Analysis (EFA) was then performed, including 120 healthy smokers who completed this new version. RESULTS: In the first study, the results from performing a CFA were not acceptable, although the scale was internally consistent. The second study showed that the new Portuguese version of GNSBQ presented reliability and 2 cor-related factors retrieved from the EFA. CONCLUSION: The new Portuguese version of the second study will contribute to an improved assessment of behavioral dependence in that population.

Association between cigarette smoking and the vaginal microbiota: a pilot study.

BACKGROUND: Smoking has been identified in observational studies as a risk factor for bacterial vaginosis (BV), a condition defined in part by decimation of Lactobacillus spp. The anti-estrogenic effect of smoking and trace amounts of benzo[a]pyrene diol epoxide (BPDE) may predispose women to BV. BPDE increases bacteriophage induction in Lactobacillus spp. and is found in the vaginal secretions of smokers. We compared the vaginal microbiota between smokers and non-smokers and followed microbiota changes in a smoking cessation pilot study. METHODS: In 2010-2011, 20 smokers and 20 non-smokers were recruited to a cross-sectional study (Phase A) and 9 smokers were enrolled and followed for a 12-week smoking cessation program (Phase B). Phase B included weekly behavioral counseling and nicotine patches to encourage smoking cessation. In both phases, participants self-collected mid-vaginal swabs (daily, Phase B) and completed behavioral surveys. Vaginal bacterial composition was characterized by pyrosequencing of barcoded 16S rRNA genes (V1-V3 regions). Vaginal smears were assigned Nugent Gram stain scores. Smoking status was evaluated (weekly, Phase B) using the semi-quantitative NicAlert® saliva cotinine test and carbon monoxide (CO) exhalation. RESULTS: In phase A, there was a significant trend for increasing saliva cotinine and CO exhalation with elevated Nugent scores (P value <0.005). Vaginal microbiota clustered into three community state types (CSTs); two dominated by Lactobacillus (L. iners, L. crispatus), and one lacking significant numbers of Lactobacillus spp. and characterized by anaerobes (termed CST-IV). Women who were observed in the low-Lactobacillus CST-IV state were 25-fold more likely to be smokers than those dominated by L. crispatus (aOR: 25.61, 95 % CI: 1.03-636.61). Four women completed Phase B. One of three who entered smoking cessation with high Nugent scores demonstrated a switch from CST-IV to a L.iners-dominated profile with a concomitant drop in Nugent scores which coincided with completion of nicotine patches. The other two women fluctuated between CST-IV and L. iners-dominated CSTs. The fourth woman had low Nugent scores with L. crispatus-dominated CSTs throughout. CONCLUSION: Smokers had a lower proportion of vaginal Lactobacillus spp. compared to non-smokers. Smoking cessation should be investigated as an adjunct to reducing recurrent BV. Larger studies are needed to confirm these findings.

A comparison of three smokeless tobacco dependence measures.

Smokeless tobacco (ST) use is associated with tobacco dependence and long-term adverse health consequences. Clinical and research tools that can accurately assess ST dependence are needed to improve research and treatment of ST users. Measures of ST dependence have been developed to address this need. We used data from a study evaluating the effectiveness of bupropion sustained release for the treatment of ST use (N=225) to compare the Fagerström Tolerance Questionnaire for Smokeless Tobacco (FTQ-ST) users, the Severson Smokeless Tobacco Dependency Scale (SSTDS), and the Glover-Nilsson Smokeless Tobacco Behavioral Questionnaire (GN-STBQ). We observed that despite the intention of the scale: (1) all scales were significantly correlated with ST cans consumed per week; (2) the FTQ-ST was significantly correlated with serum nicotine and cotinine concentrations and craving; (3) the GN-STBQ and SSTDS were significantly associated with both craving and withdrawal; and (4) none of the scales were significantly associated with ST abstinence. When all of the scales were entered simultaneously in a multivariable analysis, the SSTDS was the only scale independently associated with withdrawal and craving. As when used with cigarette smokers, the FTQ-ST appeared to measure the construct of physical dependence. The GN-STBQ and SSTDS, designed to measure broader constructs of dependence, were found to predict both withdrawal and craving which may be advantageous in clinical settings. The GN-STBQ and the FTQ-ST did not contribute significantly to the prediction of withdrawal and craving beyond what was accomplished using the SSTDS. The use of the scales is discussed in terms of clinical usefulness and how each scale might assess differing aspects of tobacco dependence.

Selegiline transdermal system (STS) as an aid for smoking cessation.

INTRODUCTION: This study examined the efficacy and safety of selegiline transdermal system (STS) and brief repeated behavioral intervention (BRBI) for smoking cessation in heavy smokers. We hypothesized that the quit rate of subjects who received STS and BRBI would be significantly greater than that of those who received placebo patch and BRBI. METHODS: This was a double-blind, placebo-controlled parallel-group study in which 246 men and women were randomized to receive either STS (n = 121) or placebo patch (n =125) for 9 weeks. Recruitment targeted heavy smokers, defined as individuals with self-reported use of ≥15 cigarettes/day in the 30 days prior to enrollment, who had smoked cigarettes for the past 5 years, and had an expired CO level ≥9 ppm during screening. RESULTS: Although STS was well tolerated, the overall results indicated that STS with BRBI was not more effective than placebo plus BRBI for smoking cessation (p = .58). CONCLUSIONS: The results are discussed in relation to interventions for heavy smokers. Although 2 trials using oral selegiline both showed trends toward improved abstinence, these results indicate that STS with BRBI was not an effective aid for smoking cessation at the end of treatment (10 weeks), 14, or 26 weeks.

Formation and early history of the American Academy of Health Behavior.

OBJECTIVE: To document the formation and early history of The American Academy of Health Behavior. METHODS: Recollections and interactions with selected founders of The Academy active in building the organization through its formative years. RESULTS: A professional organization came into existence whose sole mission is fostering research skill development and research dissemination across health behavior-related disciplines that increases the likelihood of improved translation and evidence-based practice. CONCLUSION: Creation and survival of this organization required visionary leadership, dedicated early adopters, a commitment to excellence, and outreach to new researchers.

A multicenter phase 3 trial of lobeline sulfate for smoking cessation.

OBJECTIVE: To evaluate the safety and efficacy of sublingual lobeline sulfate for smoking cessation. METHODS: A multicenter (3 sites), double-blind, parallel, placebo-controlled, phase 3 smoking cessation trial of sublingual formulation of lobeline sulfate. A total of 750 smokers (250 per site) were randomized to either treatment (lobeline sulfate) or placebo with individual smoking cessation counseling lasting up to approximately 10 minutes. RESULTS: Efficacy revealed no statistical significance (P = 0.62) for lobeline sulfate as a smoking cessation aid. CONCLUSION: Sublingual formulation of lobeline sulfate does not appear to be an effective smoking cessation aid.

Varenicline versus bupropion SR or placebo for smoking cessation: a pooled analysis.

OBJECTIVES: To evaluate varenicline's efficacy for smoking cessation versus bupropion SR and placebo and to explore whether factors typically predictive of abstinence influence varenicline's efficacy versus placebo, as measured by the week 9-12 continuous abstinence rate (CAR9-12). METHODS: Smokers in 2 randomized, placebo-controlled trials received varenicline 1 mg BID (n=696), bupropion SR 150 mg BID (n=671), or placebo (n=685) for 12 weeks. Nontreatment followup lasted 40 weeks. RESULTS: CAR(9-12) was greater for varenicline (44.0%) versus bupropion SR (29.7%; P<0.0001) and placebo (17.7%; P<0.0001). CAR(9-12) for varenicline versus placebo was not affected by age, gender, or nicotine dependence level. CONCLUSIONS: Varenicline was more efficacious than bupropion SR or placebo. Varenicline's efficacy versus placebo was not influenced by factors predictive of abstinence.

Predictors of smokeless tobacco abstinence.

OBJECTIVES: To investigate predictors of tobacco abstinence among smokeless tobacco (ST) users. METHODS: Logistic regression analyses assessed characteristics associated with tobacco abstinence among ST users receiving bupropion SR. RESULTS: Older age was associated with increased tobacco abstinence in both placebo and bupropion SR groups at end of treatment and one year. Abstinence was lower at one year for subjects with a history of major depression. At end-of-treatment, a 2-way interaction was detected suggesting bupropion SR may be efficacious for subjects with other household tobacco users. CONCLUSIONS: Younger ST users and those with a history of depression are less likely to quit ST use.

Are instructions for over-the-counter nicotine replacement therapy products readable?

OBJECTIVE: To examine readability characteristics of step-by-step directions presented in "How to Use" sections of over-the-counter (OTC) nicotine replacement therapy (NRT) products. METHODS: Step-by-step directions of all (n=6) currently available OTC NRTs were assessed on reading grade level, text point size, dimensions, and illustrations. RESULTS: The mean readability was at grade level 10.5+/-0.8, whereas the average text point size was 9.2+/-1.3. Two OTC NRT products provided illustrations to supplement step-by-step directions. CONCLUSION: As currently presented, the readability characteristics of "How to Use" sections of OTC NRTs do not facilitate consumer understanding.

Varenicline: progress in smoking cessation treatment.

Varenicline is the first pharmacological aid for smoking cessation treatment to be approved in almost a decade. Varenicline is an alpha4beta2 nicotinic acetylcholine receptor partial agonist. It may assist those who wish to quit smoking by producing partial activation at nicotinic receptors to ease craving and withdrawal symptoms; and by simultaneously blocking the effects of nicotine from cigarettes smoked, thereby reducing the satisfaction of continued smoking. The effectiveness of varenicline as an aid for smoking cessation has been demonstrated in several clinical trials versus placebo and sustained release bupropion. In addition, varenicline is well tolerated and has an acceptable safety profile. As an aid for smoking cessation, varenicline offers progress in the treatment of tobacco dependence.

A randomized, controlled trial to assess the efficacy and safety of a transdermal delivery system of nicotine/mecamylamine in cigarette smokers.

AIMS: To determine the efficacy and safety of nicotine transdermal therapy co-administered with the nicotine antagonist, mecamylamine, compared to a nicotine transdermal patch alone (21 mg nicotine + 6 mg mecamylamine, 21 mg nicotine + 3 mg mecamylamine, and 21 mg nicotine + 0 mg mecamylamine). DESIGN: Multi-center (n = 4), double-blind, randomized, parallel group, repeat-dose study. SETTING: Clinical laboratory. PARTICIPANTS: A total of 540 subjects were enrolled into the study-135 from each of four sites; 180 patients in each of three treatment arms. INTERVENTION: Treatment was administered for the first 6 weeks of the 8-week study. Patients were instructed to continue smoking for the first 2 weeks of treatment. MEASUREMENTS: The primary efficacy parameter was 4-week continuous abstinence after the quit date, confirmed with an expired carbon monoxide of < 10 parts per million. FINDINGS: Analysis of the 4-week continuous abstinence for the intent-to-treat population showed overall rates of 29% (nicotine + 6 mg mecamylamine), 29% (nicotine + 3 mg mecamylamine) and 23% (nicotine only) using the slip definition which allows smoking in the first 2 weeks after the quit date. Statistical analyses revealed no significant treatment differences. Analyses using the strict definition (no smoking after the quit date) yielded similar non-significant group differences (29%, 27%, 26%). CONCLUSION: If adding mecamylamine to nicotine replacement therapy (NRT) improves the chances of success at stopping smoking, the results of this study suggest that the effect is very small.

Sensitivity and specificity of a reagent-impregnated test strip in identifying smokeless tobacco users.

This study was designed to determine the sensitivity and specificity of a reagent-impregnated test strip in identifying habitual snuff users and tobacco chewers. Urine specimens were obtained from smokeless tobacco users and controls and blind tested on-site using a reagent-impregnated test strip. Samples also were sent to our university hospital lab for cotinine and nicotine analysis by gas chromatography (GC). The test strip results were compared with GC results and self-reported use of snuff and chewing tobacco. A total of 61 subjects enrolled in the study: 26 snuff users, 25 tobacco chewers, and 10 nonconsumers of nicotine. Using GC assessment of nicotine and cotinine (>or=200 ng/ml) as the standard, we found the sensitivity of the test strip to be 96% (25/26) for snuff users and 96% (24/25) for tobacco chewers. When compared with self-report, the sensitivity of the test strip was 92.3% (24/26) for snuff users and 84% (21/25) for tobacco chewers. The specificity for nonusers of nicotine was 100% (10/10) for both the self-report and GC conditions. These results suggest that a reagent-impregnated test strip is a rapid, valid, and user-friendly means of differentiating smokeless tobacco users from nonconsumers of tobacco. The intensity of the pink color on the test strip is proportional to the amount of nicotine or its metabolites present in urine and therefore offers a semiquantitative measure of nicotine consumption.

Bupropion SR for the treatment of smokeless tobacco use.

BACKGROUND: No pharmacotherapies have been shown to increase long-term (> or = 6 months) tobacco abstinence rates among smokeless tobacco (ST) users. Bupropion SR has demonstrated potential efficacy for ST users in pilot studies. We conducted a multicenter, randomized, double-blind, placebo-controlled, clinical trial to assess the efficacy and safety of bupropion SR for tobacco abstinence among ST users. METHODS: Adult ST users were randomized to bupropion SR titrated to 150 mg twice daily (N=113) or placebo (N=112) for 12 weeks plus behavioral intervention. The primary endpoint was the 7-day point-prevalence tobacco abstinence rate at week 12. Secondary outcomes included prolonged and continuous tobacco abstinence rates, craving and nicotine withdrawal, and weight gain. RESULTS: The 7-day point-prevalence tobacco abstinence rates did not differ between bupropion SR and placebo at the end treatment (53.1% versus 46.4%; odds ratio (OR) 1.3; p=0.301). The 7-day point-prevalence abstinence did not differ at weeks 24 and 52. The prolonged and continuous tobacco abstinence rates did not differ at weeks 12, 24, and 52. A time-by-treatment interaction was observed in craving over time with greater decreases in the bupropion SR group. At 12 weeks, the mean (+/-S.D.) weight change from baseline among abstinent subjects was an increase of 1.7 (+/-2.9)kg for the bupropion SR group compared to 3.2 (+/-2.7)kg for placebo (p=0.005). CONCLUSIONS: Bupropion SR did not significantly increase tobacco abstinence rates among ST users, but it significantly decreased craving and weight gain over the treatment period.

Efficacy of the nicotine inhaler in smoking reduction: A double-blind, randomized trial.

Many smokers are not ready to quit but are interested in changing their smoking behavior, particularly if such a change is associated with a reduction in health risk. The present study evaluated the efficacy of the nicotine inhaler in reducing smoking. Exploratory studies assessed whether reduction in smoking was associated with reduction in markers of disease risk. A total of 429 healthy smokers (smoking at least 20 cigarettes/day) were randomly assigned to either nicotine-containing or placebo inhalers, which subjects were allowed to use ad libitum for up to 1 year. The nicotine inhaler was significantly superior to placebo in achieving reduction in daily cigarette consumption by at least 50% after 4 months, compared with baseline (18% vs. 8%, p = .004). Active treatment promoted smoking cessation: 8% of subjects in the nicotine group and 1% in the placebo group were abstinent at month 15. Throughout the study, smoking reduction, per se, independent of treatment group, was associated with a statistically significant decrease in exhaled carbon monoxide and serum cotinine and thiocyanate. Smoking reduction also improved established risk markers for cardiovascular disease over 4 months. The incidence of adverse events did not differ significantly between the active and placebo groups. The most common treatment-related adverse events were throat irritation and cough. In conclusion, the nicotine inhaler can help smokers who are unable or unwilling to quit to reduce daily cigarette consumption, which may be a health benefit on its own and may further promote quitting.

Publication ethics: an examination of authorship practices.

OBJECTIVE: To review health behavior research policies and practices related to authorship credit and responsibilities and to develop an authorship policy for the American Journal of Health Behavior. METHODS: Research on authorship criteria and byline placement was reviewed and the American Journal of Health Behavior Ethics Working Group made recommendations to the editor regarding an authorship policy. RESULTS: A new authorship policy was adopted by the editor. CONCLUSIONS: The new policy clarifies the position of the journal regarding authorship issues.

Comparative efficacy of rapid-release nicotine gum versus nicotine polacrilex gum in relieving smoking cue-provoked craving.

AIMS: Most relapse episodes occur when smokers are confronted with craving provoked by situational cues. Current nicotine gum can help relieve cue-provoked cravings, but faster effects may result in more rapid relief. We tested a prototype formulation of a new rapid-release nicotine gum (RRNG) that provides more rapid release and absorption of nicotine, for its ability to provide faster and better craving relief compared to current nicotine polacrilex gum (NPG). DESIGN: Random assignment to RRNG or NPG, used during a smoking cue provocation procedure. Participants and setting A total of 319 smokers were exposed to a smoking cue in the laboratory by being asked to light but not smoke a cigarette of their preferred brand. Subjects then chewed a piece of 2 mg RRNG (n = 159) or 2 mg NPG (n = 160) according to randomized assignment. MEASUREMENTS: Craving assessments were completed at regular intervals before and after cue exposure (baseline, pre-cue, and 3, 6, 9, 12, 15, 18, 21, 25, 30 and 35 minutes after the cue). FINDINGS: Smokers chewing RRNG showed significantly lower craving than NPG subjects starting with the first assessment at 3 minutes (P < 0.025). Repeated-measures ANOVA revealed a significant treatment x time interaction (P < 0.05)-craving scores dropped more rapidly in RRNG subjects compared to NPG subjects. Survival analyses also indicated superiority of RRNG in achieving more rapid self-reported meaningful relief (P < 0.05) and complete relief (P < 0.05) of craving. CONCLUSIONS: Rapid-release nicotine gum reduced cue-provoked craving more rapidly compared to NPG, and thus merits further study in cessation efficacy trials.

Developmental history of the Glover-Nilsson smoking behavioral questionnaire.

OBJECTIVE: To develop a simple, easily administered pencil-and-paper questionnaire to determine the degree to which behavioral patterns play a role in smoking dependence. METHODS: A modified Delphi technique was used to identify initial questions and to eliminate obvious duplications. Phase 2 utilized multiple statistical methods (principal components analysis, cluster analysis, stepwise multiple linear regression, cross tables, Mantel-Haenzel c2-test, and a Gamma test) to evaluate and reduce the number of questions from 18. RESULTS: These analyses yielded an 11-item questionnaire that can potentially assess behavioral dependence. CONCLUSION: It is hoped that the GN-SBQ will assist physicians, health care providers, and tobacco interventionists in identifying aspects of smoking addiction that are behavioral in nature. The need for future research is discussed.