Food fraud and mitigating strategies of UK food supply chain during COVID-19.

Covid-19 had shown the vulnerability of the food supply chain and fraudsters may take advantage of the pandemic whilst the population needed a continuous supply of safe and quality food. The lack of monitoring and policing in the food supply chain may encourage fraudsters to upscale their operations. Previous studies had warned of a surge in fraudulent products due to COVID-19. This raised the question on whether food fraud had increased during the pandemic? This study aims to investigate food fraud during COVID-19 and how the food supply chain develops mitigating strategies against fraudulent activities. A mixed-method approach including survey and semi-structured interviews were conducted among UK food businesses. Two hundred and two agri-food businesses responded to the survey and 15 semi-structured interviews were conducted. The majority of the food businesses did not experience an increase of food fraud activities during COVID-19. Two thematic domains and ten sub-themes were identified from the data set. There was a heightened sense of anticipation and preparation for increased fraudulent activities during the pandemic. The main risk mitigating strategies included horizon scanning; developing and maintaining supplier relationship and assurance; understanding product characteristics, testing capabilities, conducting vulnerability assessments and training. Practical and cost-effective strategies for small and medium food businesses were recommended. This is the first empirical study on food fraud and mitigating strategies of the UK food supply chain during the pandemic. Our findings provide evidence for informing the policies and practices of the food regulatory authorities as well as best practices to protect the UK food supply chain against food fraud during exogenous shocks like COVID-19.

The Twin Research Registry at SRI International.

The Twin Research Registry (TRR) at SRI International is a community-based registry of twins established in 1995 by advertising in local media, mainly on radio stations and in newspapers. As of August 2012, there are 3,120 same- and opposite-sex twins enrolled; 86% are 18 years of age or older (mean age 44.9 years, SD 16.9 years) and 14% less than 18 years of age (mean age 8.9 years, SD 4.5); 67% are female, and 62% are self-reported monozygotic (MZ). More than 1,375 twins have participated in studies over the last 15 years in collaboration with the University of California Medical Center in San Francisco, the University of Texas MD Anderson Cancer Center, and the Stanford University School of Medicine. Each twin completes a registration form with basic demographic information either online at the TRR Web site or during a telephone interview. Contact is maintained with members by means of annual newsletters and birthday cards. The managers of the TRR protect the confidentiality of twin data with established policies; no information is given to other researchers without prior permission from the twins; and all methods and procedures are reviewed by an Institutional Review Board. Phenotypes studied thus far include those related to nicotine metabolism, mutagen sensitivity, pain response before and after administration of an opioid, and a variety of immunological responses to environmental exposures, including second-hand smoke and vaccination for seasonal influenza virus and Varicella zoster virus. Twins in the TRR have participated in studies of complex, clinically relevant phenotypes that would not be feasible to measure in larger samples.

Adherence to varenicline in the COMPASS smoking cessation intervention trial.

INTRODUCTION: Patient adherence to smoking cessation medications can impact their effectiveness. It is important to understand the extent to which prescribed medications are actually taken by smokers, how this influences smoking cessation outcomes, and what factors may influence adherence. METHODS: Smokers recruited from a large health plan were randomized to receive different modes of cessation counseling in combination with varenicline (Swan, G. E., McClure, J. B., Jack, L. M., Zbikowski, S. M., Javitz, H. S., Catz, S. L., et al. 2010.Behavioral counseling and varenicline treatment for smoking cessation. American Journal of Preventive Medicine, 38, 482-490). One thousand one hundred and sixty-one participants were mailed a 28-day varenicline supply when they set a quit date and were able to request up to two refills from the health plan pharmacy at no cost. Pharmacy fill records were obtained and telephone surveys completed at baseline, 21 days, 12 weeks, and 6 months post target quit date. RESULTS: Good adherence to varenicline (≥80% of days taken) was associated with a twofold increase in 6-month quit rates compared with poor adherence (52% vs. 25%). Smokers were more likely than nonsmokers to stop varenicline early. Purposeful nonadherence was associated with smoking at 12 weeks and was predicted in multivariate analyses by age, gender, adherence self-efficacy, and initial medication side effect severity. CONCLUSIONS: Innovative methods for increasing adherence to smoking cessation medications are needed, particularly early in the quit process. Simple metrics of adherence such as number of days cessation medication is taken can and should be routinely incorporated in effectiveness trials and reported to advance future attempts to understand and reduce nonadherence.

Utilization of services in a randomized trial testing phone- and web-based interventions for smoking cessation.

INTRODUCTION: Phone counseling has become standard for behavioral smoking cessation treatment. Newer options include Web and integrated phone-Web treatment. No prior research, to our knowledge, has systematically compared the effectiveness of these three treatment modalities in a randomized trial. Understanding how utilization varies by mode, the impact of utilization on outcomes, and predictors of utilization across each mode could lead to improved treatments. METHODS: One thousand two hundred and two participants were randomized to phone, Web, or combined phone-Web cessation treatment. Services varied by modality and were tracked using automated systems. All participants received 12 weeks of varenicline, printed guides, an orientation call, and access to a phone supportline. Self-report data were collected at baseline and 6-month follow-up. RESULTS: Overall, participants utilized phone services more often than the Web-based services. Among treatment groups with Web access, a significant proportion logged in only once (37% phone-Web, 41% Web), and those in the phone-Web group logged in less often than those in the Web group (mean = 2.4 vs. 3.7, p = .0001). Use of the phone also was correlated with increased use of the Web. In multivariate analyses, greater use of the phone- or Web-based services was associated with higher cessation rates. Finally, older age and the belief that certain treatments could improve success were consistent predictors of greater utilization across groups. Other predictors varied by treatment group. CONCLUSIONS: Opportunities for enhancing treatment utilization exist, particularly for Web-based programs. Increasing utilization more broadly could result in better overall treatment effectiveness for all intervention modalities.

Mood, side-effects and smoking outcomes among persons with and without probable lifetime depression taking varenicline.

BACKGROUND: Varenicline may be associated with greater mood disturbance and side-effects among smokers with psychiatric history, but empirical evidence is limited. Differential treatment effectiveness by psychiatric history may also exist. OBJECTIVE: To compare mood, prevalence and intensity of treatment side-effects, and abstinence among people with a probable history of major depression (DH+) or not (DH-) who took varenicline and received behavioral smoking cessation treatment. DESIGN: Smokers participated in a randomized behavioral intervention effectiveness trial. Treatment side-effects and outcomes were compared between DH+ and DH- participants (n = 1,117) at 21 [corrected] days and 3 months after the target quit date. PARTICIPANTS: Smokers recruited from a large regional health plan. MEASUREMENTS: Change in stress and depression scores, prevalence and intensity of treatment side-effects, and abstinence rates. RESULTS: All side-effects averaged moderate intensity or less and were similar across DH groups, except DH+'s endorsed slightly worse confusion, nausea (adjusted P = 0.04) and trouble sleeping (adjusted P = 0.008) at 21 days. Depression and stress scores declined in both DH groups and an equal proportion of each evidenced new/worsening depressive symptoms. Despite few differences in symptom intensity, more DH+ participants reported recent tension/agitation, irritability/anger, confusion, and depression at 21 days (adjusted P < 0.05), and depression and anxiety (adjusted P < 0.01) at three months. Nonsmoking rates did not differ by DH group at follow-up. CONCLUSION: While some group differences were noted, DH+ smokers did not report qualitatively worse neuropsychiatric symptoms, more new/worsening mood disturbance, or differential abstinence rates compared to DH- smokers.

Clinical trial participant characteristics and saliva and DNA metrics.

BACKGROUND: Clinical trial and epidemiological studies need high quality biospecimens from a representative sample of participants to investigate genetic influences on treatment response and disease. Obtaining blood biospecimens presents logistical and financial challenges. As a result, saliva biospecimen collection is becoming more frequent because of the ease of collection and lower cost. This article describes an assessment of saliva biospecimen samples collected through the mail, trial participant demographic and behavioral characteristics, and their association with saliva and DNA quantity and quality. METHODS: Saliva biospecimens were collected using the Oragene(R) DNA Self-Collection Kits from participants in a National Cancer Institute funded smoking cessation trial. Saliva biospecimens from 565 individuals were visually inspected for clarity prior to and after DNA extraction. DNA samples were then quantified by UV absorbance, PicoGreen(R), and qPCR. Genotyping was performed on 11 SNPs using TaqMan(R) SNP assays and two VNTR assays. Univariate, correlation, and analysis of variance analyses were conducted to observe the relationship between saliva sample and participant characteristics. RESULTS: The biospecimen kit return rate was 58.5% among those invited to participate (n = 967) and 47.1% among all possible COMPASS participants (n = 1202). Significant gender differences were observed with males providing larger saliva volume (4.7 vs. 4.5 ml, p = 0.019), samples that were more likely to be judged as cloudy (39.5% vs. 24.9%, p < 0.001), and samples with greater DNA yield as measured by UV (190.0 vs. 138.5, p = 0.002), but reduced % human DNA content (73.2 vs. 77.6 p = 0.005) than females. Other participant characteristics (age, self-identified ethnicity, baseline cigarettes per day) were associated with saliva clarity. Saliva volume and saliva and DNA clarity were positively correlated with total DNA yield by all three quantification measurements (all r > 0.21, P < 0.001), but negatively correlated with % human DNA content (saliva volume r = -0.148 and all P < 0.010). Genotyping completion rate was not influenced by saliva or DNA clarity. CONCLUSION: Findings from this study show that demographic and behavioral characteristics of smoking cessation trial participants have significant associations with saliva and DNA metrics, but not with the performance of TaqMan(R) SNP or VNTR genotyping assays. TRIAL REGISTRATION: COMPASS; registered as NCT00301145 at clinicaltrials.gov.

Predictors of 12-month outcome in smokers who received bupropion sustained-release for smoking cessation.

AIM: To examine heterogeneity in outcome at 12 months following 8 weeks of treatment for smoking cessation with bupropion sustained-release (SR) 150 or 300 mg/day combined with behavioural counselling. DESIGN, SETTING, PARTICIPANTS: Smokers were recruited from a large healthcare system and then randomized to receive either bupropion SR 150 mg/day (n = 763) or 300 mg/day (n = 761) taken for 8 weeks in combination with either proactive telephone counselling or a tailored mail approach. MEASUREMENTS AND FINDINGS: A comprehensive set of relevant individual pretreatment and treatment characteristics was included in the analysis. Smoking outcome at 12 months was defined as point-prevalence of any regular self-reported smoking within the 7 days prior to follow-up contact. Classification and regression tree analysis identified subgroups that varied with respect to likelihood of being nonsmokers at 12 months. Seven subgroups were identified among those receiving bupropion SR 150 mg/day (proportion of nonsmokers at 12 months ranged from 13.7% to 43.5%) and eight subgroups among those receiving bupropion SR 300 mg/day (proportion of nonsmokers at 12 months ranged from 9.6% to 51.7%). In the 150-mg/day group, those with the lowest rate reported no previous quit attempt of 1 month or more in duration while those with the highest rate all reported previous quit attempts of 1 month or longer. In the 300 mg/day group, those with the lowest rate had very high levels of dependence while those with the highest rate were more highly educated and smoked at a lower level. Across all subgroups, cost per 12-month quitter ranged from a low of USD302 to a high of USD2,502. CONCLUSIONS: These results indicate the presence of a substantial amount of variation in outcome following treatment with both dosages of bupropion SR, with substantial cost consequences. Variation in outcome could be reduced by providing treatments tailored to subgroups of individuals who are at exceptionally high risk for smoking following a quit attempt.

Joint effect of dopaminergic genes on likelihood of smoking following treatment with bupropion SR.

OBJECTIVE: To determine the relationship between joint variation in 2 dopaminergic genes and the likelihood of nonsmoking following treatment with bupropion sustained release (SR). DESIGN: Three hundred twenty-three participants in a bupropion SR smoking cessation effectiveness trial with 12-month follow-up were genotyped for variants of dopamine receptor gene DRD2 and dopamine transporter SLC6A3. MAIN OUTCOME MEASURES: Self-reported 7-day point prevalence of nonsmoking. RESULTS: Neither genotype alone was associated with 7-day point-prevalent nonsmoking at the 12-month follow-up. However, in the presence of the DRD2 A1 allele, SLC6A3 status was significantly associated with the likelihood of nonsmoking at the 12-month follow-up (individuals with DRD2 A1+ and SLC6A3 9- were more likely to be smoking). In the absence of the DRD2 A1 allele, the association between SLC6A3 status and nonsmoking was nonsignificant. CONCLUSION: Although these results are suggestive, a more compelling test is needed of the hypothesis that dopaminergic gene interaction underlies, in part, the likelihood of smoking following treatment with bupropion SR. Most likely this will come from larger studies involving prospective randomization to treatment based on genotype.

Financial burden of tobacco use: an employer's perspective.

To assist in determining whether employer-sponsored smoking cessation programs can be justified on cost-effectiveness grounds, a review was performed to examine the costs imposed on employers by smoking and the extent to which employers can recover those costs through successful smoking cessation programs. The magnitude of the costs (or cost savings) imposed by employee tobacco use depends on workplace factors, including medical coverage (before and after retirement), disability and life insurance benefits, level of exposure to workplace pollutants associated with smoking-related diseases, employee turnover rate, current smoke-free area policy, smoking breaks policy, cost of providing smoking areas, and type of retirement pension plan.

Effectiveness of bupropion sustained release for smoking cessation in a health care setting: a randomized trial.

BACKGROUND: The efficacy of bupropion hydrochloride sustained release (SR) (Zyban) for smoking cessation has been evaluated in clinical trials that included frequent in-person behavioral counseling, but not in actual practice settings. OBJECTIVE: To determine the differential effectiveness of 2 doses of bupropion SR in combination with behavioral interventions of minimal to moderate intensity in an actual practice setting. DESIGN: Open-label randomized trial, with 1 year of follow-up. SETTING: A large health system (Group Health Cooperative) based in Seattle. PARTICIPANTS: Adult smokers (N = 1524) interested in quitting smoking. INTERVENTIONS: Participants were randomly assigned to receive 1 of 4 combinations of bupropion SR (150 or 300 mg) and behavioral counseling (minimal or moderate intensity). MAIN OUTCOME MEASURES: The primary outcome measure was self-reported point-prevalence 7-day nonsmoking status at 3 and 12 months following the target quit date. Secondary outcomes included adverse and abstinence effects reported since beginning treatment with bupropion SR. RESULTS: At 3 months, a significantly higher rate of nonsmoking was observed among those receiving the larger bupropion SR dose (P=.005). At 12 months, moderate intensity counseling was associated significantly with a higher rate of nonsmoking (P=.001). At 3 months, the higher dose was associated with a significantly increased frequency of self-reported symptoms such as difficulty sleeping (P=.02), difficulty concentrating (P=.02), shakiness/tremor (P=.002), and gastrointestinal problems (P=.005)and a decreased frequency of reported desire to smoke (P=.001). CONCLUSIONS: In this actual practice setting, the combination of bupropion SR and minimal or moderate counseling was associated with 1-year quit rates of 23.6% to 33.2%. This suggests that existing health care systems can substantially decrease tobacco use rates among their enrollees if they provide these modest interventions.

Environmental and genetic determinants of tobacco use: methodology for a multidisciplinary, longitudinal family-based investigation.

This article describes the ongoing collaborative effort of six research teams to operationalize and execute an integrative approach to the study of gene x environment interactions in the development of tobacco dependence. At the core of the project is a longitudinal investigation of social and behavioral risk factors for tobacco use in individuals who were, on average, 13 years of age at intake and for whom smoking outcomes extending from early adolescence to young adulthood have been characterized previously (current average age of the cohort is 29 years). The conceptual framework for the integrative approach and the longitudinal investigation on which the study is based is presented. A description is also provided of the methods used to: (a) recruit participants and families to provide DNA samples and information on tobacco use; (b) assess participants for relevant tobacco-related phenotypes including smoking history, current use of tobacco, and nicotine metabolism; (c) assess the quality of the DNA samples collected from participants for genome-wide scanning and candidate gene analysis; (d) examine several research questions concerning the role of genetic and environmental factors in the onset and maintenance of tobacco use; and (e) ensure adherence to local and federal guidelines for ethical and legal investigations of genotypic associations with tobacco-related phenotypes in families. This investigation is unique among ongoing studies of the genetics of tobacco dependence in the extent to which equal importance has been assigned to both phenotypic and genotypic measurements.

Heterogeneity in 12-month outcome among female and male smokers.

AIMS: To examine heterogeneity in outcome following treatment for smoking cessation with combined bupropion SR and behavioral counseling in women and men. DESIGN, SETTING, PARTICIPANTS: This study included 875 women and 649 men recruited from a large health-care system and randomized to one of four combinations of treatment [two dosage levels of bupropion SR (Zyban, 150 mg and 300 mg) were crossed with two counseling programs of lower and higher intensity to create a four-cell design]. MEASUREMENTS AND FINDINGS: A comprehensive set of relevant individual characteristics prior to treatment and treatment characteristics was included in the analysis. Smoking outcome at 12 months was defined as point-prevalence of any regular smoking within the 7 days prior to follow-up contact. Classification and regression tree analysis identified six subgroups in women that ranged in proportion of non-smokers from 9.8% to 42.9% and six subgroups in men that ranged in proportion of non-smokers from 17.3% to 50.0%. CONCLUSIONS: These results indicate the presence of a substantial amount of variation in treatment outcome among women and men receiving combined bupropion SR and counseling. Variation in outcome could be reduced by providing treatments tailored to subgroups of individuals who are at exceptionally high risk for smoking following cessation.

Cost-effectiveness of different combinations of bupropion SR dose and behavioral treatment for smoking cessation: a societal perspective.

OBJECTIVES: To determine the differential cost effectiveness of 2 dosing regimens of bupropion sustained release (SR) in combination with behavioral interventions of minimal intensity (tailored mailings [TM]) or moderate intensity (proactive telephone calls [PTC]) for smoking cessation in an actual practice setting. STUDY DESIGN: Open-label, randomized trial, with 1-year follow-up, conducted in a large health system based in Seattle, Washington. METHODS: A total of 1524 adult smokers interested in quitting smoking were randomly assigned to receive 150 mg bupropion SR daily and PTC (n = 382), 150 mg bupropion SR daily and TM (n = 381), 300 mg bupropion SR daily and PTC (n = 383), or 300 mg bupropion SR daily and TM (n = 378). Sufficient medication for 8 weeks of dosing was provided to patients. The primary outcome measure was self-reported point-prevalence 7-day nonsmoking status at 12 months after the target quit date. RESULTS: Although the 300-mg dose was associated with a higher 12-month nonsmoking rate relative to the 150-mg dose with both PTC and TM, the additional cost resulted in lower cost effectiveness. The PTC behavioral intervention was more expensive than TM, but the additional effectiveness resulted in almost equivalent cost effectiveness at the 150-mg dose. Costs per additional 12-month nonsmoker (above that expected for placebo) for the 150-mg dose groups averaged 950 dollars and per additional lifetime quitter averaged 1508 dollars; for the 300-mg groups these costs were 1342 dollars and 2129 dollars, respectively. Cost per life-year and quality-adjusted life-years (QALYs) saved varied substantially by age and treatment, but were no greater than 1100 dollars for all treatment groups when averaged across the age and sex distribution for the study population. CONCLUSIONS: Although the cost per life-year and QALYs saved were sufficiently low for all doses to rate these smoking cessation interventions as among the most cost effective of life-saving medical treatments, within the regimens tested 150 mg bupropion combined with either PTC or TM was the most cost effective.

Outcomes from a patient-centered residential treatment plan for tobacco dependence.

St. Helena Hospital launched the first US residential stop-smoking program, The St. Helena Center for a Smoke-Free Life, in 1969. This observational report describes the center's treatment outcome rate for using a patient-centered approach to the use of tobacco dependence medications and behavioral treatment for patients who participated in the program from January 1, 2005 through December 31, 2007. A total of 284 patients used long-acting (nicotine patch, bupropion, and varenicline) and/or short-acting medications (nicotine nasal spray, nicotine gum, nicotine lozenge, and nicotine oral inhaler) alone or in combination during treatment and after discharge. Seven patients chose to use no medications. Patients using nicotine patch received a mean ± SD dose of 33.3±15.7 mg of nicotine in 16 hours (range, 5-90 mg). The 12-month 7-day point prevalence smoking abstinence rate after participation in the intensive, 1-week, residential program was 57.0%. Recommendations are discussed for future research and for implementing aspects of the St. Helena program in other treatment settings.

Asthma discordance in twins is linked to epigenetic modifications of T cells.

T cells mediate the inflammatory responses observed in asthma among genetically susceptible individuals and have been suspected to be prone to epigenetic regulation. However, these relationships are not well established from past clinical studies that have had limited capacity to control for the effects of variable genetic predisposition and early environmental exposures. Relying on a cohort of monozygotic twins discordant for asthma we sought to determine if epigenetic modifications in T cells were associated with current asthma and explored whether such modifications were associated with second hand smoke exposures. Our study was conducted in a monozygotic twin cohort of adult twin pairs (n = 21) all discordant for asthma. Regulatory T cell (Treg) and effector T cell (Teff) subsets were assessed for levels of cellular function, protein expression, gene expression and CpG methylation within Forkhead box P3 (FOXP3) and interferon gamma-γ (IFNγ) loci. Comparisons by asthma and current report of exposure to second hand smoke were made. Treg from asthmatic discordant twins demonstrated decreased FOXP3 protein expression and impaired Treg function that was associated with increased levels of CpG methylation within the FOXP3 locus when compared to their non-asthmatic twin partner. In parallel, Teff from discordant asthmatic twins demonstrated increased methylation of the IFNγ locus, decreased IFNγ expression and reduced Teff function when compared to Teff from the non-asthmatic twin. Finally, report of current exposure to second hand smoke was associated with modifications in both Treg and Teff at the transcriptional level among asthmatics. The results of the current study provide evidence for differential function of T cell subsets in monozygotic twins discordant for asthma that are regulated by changes in DNA methylation. Our preliminary data suggest exposure to second hand smoke may augment the modified T cell responses associated with asthma.

Cost-effectiveness of varenicline and three different behavioral treatment formats for smoking cessation.

There is a lack of evidence of the relative cost-effectiveness of proactive telephone counseling (PTC) and Web-based delivery of smoking cessation services in conjunction with pharmacotherapy. We calculated the differential cost-effectiveness of three behavioral smoking cessation modalities with varenicline treatment in a randomized trial of current smokers from a large health system. Eligible participants were randomized to one of three smoking cessation interventions: Web-based counseling (n=401), PTC (n=402), or combined PTC-Web counseling (n=399). All participants received a standard 12-week course of varenicline. The primary outcome was a 7-day point prevalent nonsmoking at the 6month follow-up. The Web intervention was the least expensive followed by the PTC and PTC-Web groups. Costs per additional 6-month nonsmoker and per additional lifetime quitter were $1,278 and $2,601 for Web, $1,472 and $2,995 for PTC, and $1,617 and $3,291 for PTC-Web. Cost per life-year (LY) and quality-adjusted life-year (QALY) saved were $1,148 and $1,136 for Web, $1,320 and $1,308 for PTC, and $1,450 and $1,437 for PTC-Web. Based on the cost per LY and QALY saved, these interventions are among the most cost-effective life-saving medical treatments. Web, PTC, and combined PTC-Web treatments were all highly cost-effective, with the Web treatment being marginally more cost-effective than the PTC or combined PTC-Web treatments.

Behavioral counseling and varenicline treatment for smoking cessation.

BACKGROUND: Smoking remains the primary preventable cause of death and illness in the U.S. Effective, convenient treatment programs are needed to reduce smoking prevalence. PURPOSE: This study compared the effectiveness of three modalities of a behavioral smoking-cessation program in smokers using varenicline. METHODS: Current treatment-seeking smokers (n=1202) were recruited from a large healthcare organization between October 2006 and October 2007. Eligible participants were randomized to one of three smoking-cessation interventions: web-based counseling (n=401); proactive telephone-based counseling (PTC; n=402); or combined PTC and web counseling (n=399). All participants received a standard 12-week FDA-approved course of varenicline. Self-report determined the primary outcomes (7-day point prevalent abstinence at 3- and 6-month follow-ups); the number of days varenicline was taken; and treatment-related symptoms. Behavioral measures determined utilization of both the web- and Phone-based counseling. RESULTS: Intent-to-treat analyses revealed relatively high percentages of abstinence at 3 months (38.9%, 48.5%, 43.4%) and at 6 months (30.7%, 34.3%, 33.8%) for the web, PTC, and PTC-web groups, respectively. The PTC group had a significantly higher percentage of abstinence than the web group at 3 months (OR=1.48, 95% CI=1.12, 1.96), but no between-group differences in abstinence outcomes were seen at 6 months. CONCLUSIONS: Phone counseling had greater treatment advantage for early cessation and appeared to increase medication adherence, but the absence of differences at 6 months suggests that any of the interventions hold promise when used in conjunction with varenicline.

Smoking outcome by psychiatric history after behavioral and varenicline treatment.

Treatment outcomes were compared across smokers enrolled in the COMPASS cessation trial with (positive psychiatric history [PH+], n = 271) and without (PH-, n = 271) a diagnosis of PH based on medical record evidence of anxiety, depression, psychotic disorder, or bipolar disorder. Everyone received behavioral counseling plus varenicline and was followed for 6 months post quit date. PH+ smokers took varenicline for fewer days on average (59.4 vs. 68.5, p < or = .01) but did not differ in their use of behavioral treatment. PH+ smokers were more likely to report anxiety and depression, but side-effect intensity ratings did not differ after adjusting for multiple comparisons. Overall, all side effects were rated as moderate intensity or less. Groups had similar 30-day abstinence rates at 6 months (31.5% PH+ vs. 35.4% PH-, p = .35). In sum, having a psychiatric diagnosis in this trial did not predict worse treatment outcome or worse treatment side effects.

Resequencing of nicotinic acetylcholine receptor genes and association of common and rare variants with the Fagerström test for nicotine dependence.

Common single-nucleotide polymorphisms (SNPs) at nicotinic acetylcholine receptor (nAChR) subunit genes have previously been associated with measures of nicotine dependence. We investigated the contribution of common SNPs and rare single-nucleotide variants (SNVs) in nAChR genes to Fagerström test for nicotine dependence (FTND) scores in treatment-seeking smokers. Exons of 10 genes were resequenced with next-generation sequencing technology in 448 European-American participants of a smoking cessation trial, and CHRNB2 and CHRNA4 were resequenced by Sanger technology to improve sequence coverage. A total of 214 SNP/SNVs were identified, of which 19.2% were excluded from analyses because of reduced completion rate, 73.9% had minor allele frequencies <5%, and 48.1% were novel relative to dbSNP build 129. We tested associations of 173 SNP/SNVs with the FTND score using data obtained from 430 individuals (18 were excluded because of reduced completion rate) using linear regression for common, the cohort allelic sum test and the weighted sum statistic for rare, and the multivariate distance matrix regression method for both common and rare SNP/SNVs. Association testing with common SNPs with adjustment for correlated tests within each gene identified a significant association with two CHRNB2 SNPs, eg, the minor allele of rs2072660 increased the mean FTND score by 0.6 Units (P=0.01). We observed a significant evidence for association with the FTND score of common and rare SNP/SNVs at CHRNA5 and CHRNB2, and of rare SNVs at CHRNA4. Both common and/or rare SNP/SNVs from multiple nAChR subunit genes are associated with the FTND score in this sample of treatment-seeking smokers.

Impact of symptoms experienced by varenicline users on tobacco treatment in a real world setting.

This article examines reported symptoms, nonsmoking rates, and medication use among 1,018 smokers using varenicline in a randomized trial comparing three forms of behavioral support for smoking cessation (phone, Web, or phone + Web). One month after beginning varenicline, 168 people (17%) had discontinued the medication. Most (53%) quit due to side effects and other symptoms. The most common side effect among all users was nausea (reported by 57% of users). At 1 month post medication initiation, those not taking varenicline were more likely to report smoking than those who continued the medication (57% vs. 16%, p < .001). Women reported more symptoms but did not discontinue medication at higher rates. Participants who received any telephone counseling (n = 681) were less likely to discontinue their medication than those with Web support only (15% vs. 21%, p < .01). Counseling may improve tolerance of this medication and reduce the rate of discontinuation due to side effects.