Effect of Cytisine vs Varenicline on Smoking Cessation: A Randomized Clinical Trial.

Importance: Cytisine is more effective than placebo and nicotine replacement therapy for smoking cessation. However, cytisine has not been tested against the most effective smoking cessation medication, varenicline, which is associated with adverse events known to lead to discontinuation of therapy. Objective: To examine whether standard cytisine treatment (25 days) was at least as effective as standard varenicline treatment (84 days) for smoking cessation. Design, Setting, and Participants: This noninferiority, open-label randomized clinical trial with allocation concealment and blinded outcome assessment was undertaken in Australia from November 2017 through May 2019; follow-up was completed in January 2020. A total of 1452 Australian adult daily smokers willing to make a quit attempt were included. Data collection was conducted primarily by computer-assisted telephone interview, but there was an in-person visit to validate the primary outcome. Interventions: Treatments were provided in accordance with the manufacturers' recommended dosage: cytisine (n = 725), 1.5-mg capsules taken 6 times daily initially then gradually reduced over the 25-day course; varenicline (n = 727), 0.5-mg tablets titrated to 1 mg twice daily for 84 days (12 weeks). All participants were offered referral to standard telephone behavioral support. Main Outcomes and Measures: The primary outcome was 6-month continuous abstinence verified using a carbon monoxide breath test at 7-month follow-up. The noninferiority margin was set at 5% and the 1-sided significance threshold was set at .025. Results: Among 1452 participants who were randomized (mean [SD] age, 42.9 [12.7] years; 742 [51.1%] women), 1108 (76.3%) completed the trial. Verified 6-month continuous abstinence rates were 11.7% for the cytisine group and 13.3% for the varenicline group (risk difference, -1.62% [1-sided 97.5% CI, -5.02% to ∞]; P = .03 for noninferiority). Self-reported adverse events occurred less frequently in the cytisine group (997 events among 482 participants) compared with the varenicline group (1206 events among 510 participants) and the incident rate ratio was 0.88 (95% CI, 0.81 to 0.95; P = .002). Conclusions and Relevance: Among daily smokers willing to quit, cytisine treatment for 25 days, compared with varenicline treatment for 84 days, failed to demonstrate noninferiority regarding smoking cessation. Trial Registration: anzctr.org.au Identifier: ACTRN12616001654448.

Nutrition among men and household food security in an internally displaced persons camp in Kenya.

OBJECTIVE: To determine the nutritional status of men and the food security status of their households in an internally displaced persons (IDP) camp in Kenya. DESIGN: A descriptive, cross-sectional study using a questionnaire and biometric measurements was completed in June 2013. SETTING: IDP camp, Rongai, Kenya. SUBJECTS: A total of 267 men aged ≥18 years residing within the camp were recruited via respondent-driven sampling. Statistical associations between categorical variables were analysed using Pearson's χ 2 tests, while independent t tests were used for continuous variables. RESULTS: Among the men surveyed, we found a mean BMI of 20·3 (sd 2·5) kg/m2, with 23·9% of participants in the underweight category (BMI<18·5 kg/m2). The mean Individual Dietary Diversity Score was 6 out of a maximum score of 9. The mean Household Food Insecurity Access Scale score was 11·6 (sd 6·8), with 180 participants (71·7%) residing in households categorised as severely food insecure. Low monthly household income (<2000 Kenyan Shillings, or $US 25) was associated with a higher food insecurity score (P<0·001), greater likelihood of residing in a severely food-insecure household (P<0·001), low dietary diversity score (P<0·05) and being underweight (P<0·01). CONCLUSIONS: While the nutritional status of men in the IDP camp is comparable to non-displaced men in Kenya, household food insecurity is relatively high. Efforts to improve food security for the future are essential to minimise the impact of severe food insecurity on mental health, disease profiles and family well-being reported in other IDP settings.

Process evaluation of a practice nurse-led smoking cessation trial in Australian general practice: views of general practitioners and practice nurses.

BACKGROUND: Support in primary care can assist smokers to quit successfully, but there are barriers to general practitioners (GPs) providing this support routinely. Practice nurses (PNs) may be able to effectively take on this role. OBJECTIVES: The aim of this study was to perform a process evaluation of a PN-led smoking cessation intervention being tested in a randomized controlled trial in Australian general practice. METHODS: Process evaluation was conducted by means of semi-structured telephone interviews with GPs and PNs allocated in the intervention arm (Quit with PN) of the Quit in General Practice trial. Interviews focussed on nurse training, content and implementation of the intervention. RESULTS: Twenty-two PNs and 15 GPs participated in the interviews. The Quit with PN intervention was viewed positively. Most PNs were satisfied with the training and the materials provided. Some challenges in managing patient data and follow-up were identified. CONCLUSION: The Quit with PN intervention was acceptable to participating PNs and GPs. Issues to be addressed in the planning and wider implementation of future trials of nurse-led intervention in general practice include providing ongoing mentoring support, integration into practice management systems and strategies to promote greater collaboration in GPs and PN teams in general practice. The ongoing feasibility of the intervention was impacted by the funding model supporting PN employment and the competing demands on the PNs time.

Quit in general practice: a cluster randomized trial of enhanced in-practice support for smoking cessation.

OBJECTIVES: To evaluate the uptake and effectiveness of tailored smoking cessation support, provided primarily by the practice nurse (PN), and compare this to other forms of cessation support. METHODS: Three arm cluster randomized controlled trial conducted in 101 general practices in Sydney and Melbourne involving 2390 smokers. The Quit with PN intervention was compared to Quitline referral and a usual care control group. Smoking cessation pharmacotherapy was recommended to all groups. Outcomes were assessed by self-report at 3- and 12-month follow-up. Uptake of the interventions is also reported. RESULTS: The three groups were similar at baseline. Follow-up at 12 months was 82%. The sustained and point prevalence abstinence rates, respectively, at 3 months by group were: PN intervention 13.1% and 16.3%; Quitline referral 10.8% and 14.2%; Usual GP care 11.4% and 15.0%. At 12 months, the rates were: PN intervention 5.4% and 17.1%; Quitline referral 4.4% and 18.8%; Usual GP care 2.9% and 16.4%. Only 43% of patients in the PN intervention group attended to see the nurse. Multilevel regression analysis showed no effect of the intervention overall, but patients who received partial or complete PN support were more likely to report sustained abstinence [partial support odds ratio (OR) 2.27; complete support OR 5.34]. CONCLUSION: The results show no difference by group on intention to treat analysis. Those patients who received more intensive PN intervention were more likely to quit. This may have been related to patient motivation or an effect of PN led cessation support.

Tobacco smoking: options for helping smokers to quit.

BACKGROUND: Although great progress has been made on tobacco control, smoking remains one of the most important causes of preventable disease and death in the Australian population. The general practice team has much to offer in helping smokers to quit. OBJECTIVE: This article provides practical advice on structuring smoking cessation support in primary care using the 5As (Ask, Assess, Advise, Assist and Arrange follow-up) framework. Up-to-date information on pharmacotherapy and issues for special groups are also covered. DISCUSSION: The chances of successful quitting are maximised if the patient receives behavioural support combined with drug treatment, if nicotine-dependent. Special groups needing support include Aboriginal and Torres Strait Islander peoples, people with mental illness and pregnant women.

Heroin use impairs smoking cessation among Australian prisoners.

BACKGROUND: Prisoners have extremely high rates of smoking with rates 3-4 times higher than the general community. Many prisoners have used heroin. The aims of this study were to investigate the impact of heroin use on smoking cessation and the social determinants of health among prisoners. METHODS: Secondary analysis of data from a randomised controlled trial of a multi-component smoking cessation intervention involving 425 Australian male prisoners. Inmates who, prior to imprisonment, used heroin regularly were compared to those who did not use heroin regularly. Self-reported smoking status was validated at baseline and each follow-up by measuring carbon monoxide levels. Readings exceeding 10 ppm were defined as indicating current smoking. RESULTS: Over half (56.5%) of the participants had ever used heroin while 37.7% regularly (daily or almost daily) used heroin in the year prior to entering prison. Prisoners who regularly used heroin had significantly worse social determinants of health and smoking behaviours, including lower educational attainment, more frequent incarceration and earlier initiation into smoking. Prisoners who regularly used heroin also used and injected other drugs significantly more frequently. At 12-month follow-up, the smoking cessation of prisoners who had regularly used heroin was also significantly lower than prisoners who did not regularly use heroin, a finding confirmed by logistic regression. CONCLUSIONS: Regular heroin use prior to imprisonment is an important risk factor for unsuccessful attempts to quit smoking among prisoners and is also associated with worse social determinants of health, higher drug use, and worse smoking behaviours. More effective and earlier smoking cessation interventions are required for particularly disadvantaged groups. TRIAL REGISTRATION: This trial is registered with the Australian New Zealand Clinical Trials Registry 12606000229572.

Impact of smoking bans and other smoking cessation interventions in prisons, mental health and substance use treatment settings: A systematic review of the evidence.

ISSUES: We conducted a systematic review to examine whether smoking bans alone are effective in achieving smoking cessation in people released from prison, and patients discharged from mental health or substance use settings. APPROACH: We searched health, criminology and social science databases. Detailed search strings were used to combine terms related to smoking bans and cessation interventions in prison, mental health and substance use treatment settings. We used backward and forward snowballing and manual hand searching to find additional studies. Studies were included if they: were published between 1 January 2000 and 25 February 2022; included a complete smoking ban; measured people released from prison and/or mental health and/or substance use patients smoking post-release/discharge from a smoke-free facility; and reported smoking cessation intervention and/or smoking ban outcomes. Methodological quality was assessed using the Effective Public Health Practice Project's Quality Assessment Tool for Quantitative Studies and reviewed by two authors. KEY FINDINGS: People released from prison, mental health and substance use in-patients who experience a smoking ban while incarcerated or in in-patient settings often relapse to smoking shortly after release or discharge. We found that although smoking bans alone do not promote cessation, multi-component interventions in combination with smoking bans can significantly increase cessation rates post-release/discharge provided they support participants during this time. CONCLUSIONS: There is limited evidence to suggest tobacco bans alone in prison, mental health and substance use treatment settings are effective in achieving long-term smoking cessation. This review suggests that combining smoking bans and cessation interventions including pre- and post-release/discharge support can be effective in achieving smoking cessation.

Effectiveness, safety and cost-effectiveness of vaporized nicotine products versus nicotine replacement therapy for tobacco smoking cessation in a low-socioeconomic status Australian population: a study protocol for a randomized controlled trial.

BACKGROUND: In Australia, tobacco smoking rates have declined but inequalities remain with significantly higher smoking prevalence among low-socioeconomic populations. Clinical trial data suggest vaporized nicotine products (VNPs) aid smoking cessation. Most VNP trials have used refillable tank systems, but newer generation (pod) devices now comprise the largest market share yet have limited clinical trial evidence on safety and effectiveness. This study evaluates the effectiveness, safety and cost-effectiveness of VNPs (pod and tank device) compared with nicotine replacement therapy ([NRT]-gum or lozenge) for smoking cessation. METHODS: This is a two-arm, open-label, superiority, parallel group, randomized controlled trial (RCT) with allocation concealment and blinded outcome assessment. The RCT is conducted at the National Drug and Alcohol Research Centre at the University of New South Wales, Sydney, Australia. Participants are people who smoke daily, are interested in quitting and receive a government pension or allowance (N = 1058). Participants will be randomized (1:1 ratio) to receive 8 weeks of free: VNPs, with pod (40 mg/mL nicotine salt) and tank device (18 mg/mL freebase nicotine) in mixed flavours; or NRT (gum or lozenge; 4 mg). All participants will receive daily text message behavioural support for 5 weeks. Assessments will be undertaken by telephone at baseline, with three follow-up calls (two check-in calls within the first month and final follow-up at 7 months post randomization) to ascertain smoking status, treatment adherence and adverse events. The primary outcome is 6-month continuous abstinence verified by carbon monoxide breath test of ≤5ppm at 7-month follow-up. Safety and cost-effectiveness of VNPs versus NRT will also be evaluated. DISCUSSION: Further data are required to strengthen certainty of evidence for VNPs aiding smoking cessation, particularly for newer generation pod devices. To our knowledge, this trial is the first to offer choice of VNPs and no comparative effectiveness trial data exists for new pod devices. If effective, the findings can inform wider implementation of VNPs to aid smoking cessation in a priority group. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12621000076875. Registered on 29 January 2021.  https://www.anzctr.org.au.

Cardiovascular risk among Aboriginal and non-Aboriginal smoking male prisoners: inequalities compared to the wider community.

BACKGROUND: Cardiovascular risk factors (CVRF) were collected as part of a randomised controlled trial of a multi-component intervention to reduce smoking among male prisoners. Cross-sectional baseline data on CVRF were compared among smoking male prisoners and males of similar age in the general population. METHODS: 425 smoking prisoners were recruited (n = 407 in New South Wales; 18 in Queensland), including 15% of Aboriginal descent (mean age 33 years; median sentence length 3.6 years). We measured CVRF such as smoking, physical activity, blood pressure, risky alcohol use, symptoms of depression, and low socioeconomic status. RESULTS: We found that 39% of prisoners had 3+ CVRF, compared to 10% in a general community sample of most disadvantaged men of a similar age. Significantly more Aboriginal prisoners had 3+ CVRF than non-Aboriginal prisoners (55% vs 36%, p < 0.01) and were twice as likely to have 4+ CVRF (27% vs 12%). In addition to all prisoners in this study being a current smoker (with 70% smoking 20+ cigarettes per day), the prevalence of other CVRF was very high: insufficient physical activity (23%); hypertension (4%), risky drinking (52%), symptoms of depression (14%) and low socioeconomic status (SES) (44%). Aboriginal prisoners had higher levels of risky alcohol use, symptoms of depression, and were more likely to be of low SES. CONCLUSION: Prisoners are at high risk for developing cardiovascular disease compared to even the most disadvantaged in their community and should be the focus of specific public health interventions. TRIAL REGISTRATION: This trial is registered with the Australian New Zealand Clinical Trials Registry ACTRN#12606000229572.

General practice patients--their readiness to quit smoking.

BACKGROUND: This article examines the prevalence of smoking among general practice patients and assesses their stage of readiness to quit. METHOD: Descriptive study involving eight general practice registrars working in teaching practices in metropolitan Sydney (New South Wales) who surveyed 1069 consecutive patients over 16 years of age to determine their smoking status; and for smokers, their stage of readiness to stop smoking. RESULTS: Of these patients 375 (35%) were current smokers, with smoking more common among men (40%) than women (33%). Proportions of smokers in each stage of change were: 137 in precontemplation (36.5%), 158 in contemplation (42%) and 79 in preparation (21%). The majority of patients in preparation (67%) and contemplation (53%) were assessed as willing to further discuss their smoking, whereas only 16% of those in the contemplation stage were willing. DISCUSSION: Smoking rates among general practice patients were higher than in community samples. Most of the smokers were either contemplating or preparing to quit, and the majority of smokers in these groups were willing to receive advice about smoking cessation.

Ten-year survival outcome of the nicotine transdermal patch with cognitive behavioural therapy.

OBJECTIVE: To follow-up abstainers from the end of their initial treatment over seven points to 10 years. METHODS: In the original study there were 305 smokers who were recruited in a double-blind randomised controlled trial. Those subjects who had remained continuously abstinent to seven years (n=20) were followed up to ascertain continuous smoking prevalence to 10 years. Main outcome measure was continuous abstinence. RESULTS: At 10 years, the active nicotine patch group showed significantly higher continuous abstinence rates that were double those of the placebo group (7.9% vs. 2.6%, respectively). The high rate of relapse declined after six months. CONCLUSIONS: The nicotine patch leads to superior continuous abstinence over 10 years when compared with placebo. PUBLIC HEALTH IMPLICATIONS: This is the longest follow-up study of continuous smoking abstinence after cognitive behaviour treatment combined with the nicotine patch.

Plasma apolipoproteins and physical and cognitive health in very old individuals.

Apolipoproteins play a crucial role in lipid metabolism with implications in cardiovascular disease, obesity, diabetes, Alzheimer's disease, and longevity. We quantified 7 apolipoproteins in plasma in 1067 individuals aged 56-105 using immunoassays and explored relationships with APOE polymorphism ε2/3/4, vascular health, frailty, and cognition. ApoA1, ApoA2, ApoB, ApoC3, ApoE, ApoH, and ApoJ decreased from mid-life, although ApoE and ApoJ had U-shaped trends. Centenarians had the highest ApoE levels and the lowest frequency of APOE ε4 allele relative to younger groups. Apolipoprotein levels trended lower in APOE ε4 homozygotes and heterozygotes compared with noncarriers, with ApoE and ApoJ being significantly lower. Levels of all apolipoproteins except ApoH were higher in females. Sex- and age-related differences were apparent in the association of apolipoproteins with cognitive performance, as only women had significant negative associations of ApoB, ApoE, ApoH, and ApoJ in mid-life, whereas associations at older age were nonsignificant or positive. Our findings suggest levels of some apolipoproteins, especially ApoE, are associated with lifespan and cognitive function in exceptionally long-lived individuals.

Promoting smoking cessation among prisoners: feasibility of a multi-component intervention.

OBJECTIVE: To conduct a pilot study to determine the feasibility and effectiveness of a multi-component smoking cessation intervention among prison inmates. METHODS: A prospective study conducted within a maximum-security prison located near Sydney, New South Wales, and housing around 330 men. Participants received a smoking cessation intervention with six-month follow-up to determine abstinence. The smoking cessation intervention consisted of two brief cognitive behavioural therapy sessions, nicotine replacement therapy, bupropion and self-help resources. Point prevalence and continuous abstinence at follow-up were verified with expired carbon monoxide measures. RESULTS: Thirty male inmates participated in the intervention. At six months, the biochemically validated point prevalence and continuous abstinence rates were 26% and 22% respectively. Reasons for relapse to smoking included: transfers to other prisons without notice, boredom, prolonged periods locked in cells, and stress associated with family or legal concerns. Those inmates who relapsed, or continued to smoke following the intervention, smoked less tobacco than at baseline and 95% stated they were willing to try to quit again using our intervention. CONCLUSIONS: Prison inmates are able to quit or reduce tobacco consumption while in prison but any smoking cessation intervention in this setting needs to address prison-specific issues such as boredom, stress, transfers to other prisons, court appearances, and isolation from family and friends. IMPLICATIONS: The prevalence of smoking within Australian prisons is alarmingly high. Further work into how to encourage prisoners to quit smoking is required.

Evaluation of a multi-component community tobacco intervention in three remote Australian Aboriginal communities.

OBJECTIVES: To assess the effect of community tobacco interventions in Aboriginal communities. METHODS: The study consisted of a pre- and post-study of the effect of a multi-component tobacco intervention conducted in six Aboriginal communities in the Northern Territory (NT). The intervention included sports sponsorship, health promotion campaigns, training health professionals in the delivery of smoking cessation advice, school education about tobacco, and policy on smoke-free public places. The study was conducted in three intervention communities and three matched control communities. Surveys were used to measure changes in prevalence of tobacco use, changes in knowledge, and attitudes to cessation in intervention communities. RESULTS: Tobacco consumption decreased in one intervention community compared with the matched control community; the trends of consumption (as measured by tobacco ordered through points of sale) in these communities were significantly different (t = -4.5, 95% CI -33.6 - (-12.5), p < or = 0.01). Community samples in intervention communities included 920 participants. There was no significant change in the prevalence of tobacco use, although knowledge of the health effects of tobacco and readiness to quit increased. CONCLUSIONS: Although it is difficult to demonstrate a reduction in tobacco consumption or in the prevalence of tobacco use as a result of multi-component community tobacco interventions delivered in Aboriginal communities, such interventions can increase awareness of the health effects of tobacco and increase reported readiness to cease tobacco use.

Role of the general practitioner in smoking cessation.

This paper reflects on the role of general practitioners in smoking cessation and suggests initiatives to enhance general practice as a setting for effective smoking cessation services. This paper is one of a series of reflections on key issues in smoking cessation. In this article we highlight the extent that general practitioners (GPs) have contact with the population, evidence for effectiveness of GP advice, barriers to greater involvement and suggested future directions. General practice has an extensive population reach, with the majority of smokers seeing a GP at least once per year. Although there is level 1 evidence of the effectiveness of smoking cessation advice from general practitioners, there are substantial barriers to this advice being incorporated routinely into primary care consultations. Initiatives to overcome these barriers are education in smoking cessation for GPs and other key practice staff; teaching of medical students about tobacco and cessation techniques, clinical practice guidelines; support for guideline implementation; access to pharmacotherapies; and development of referral models. We believe the way forward for the role of the GPs is to develop the practice as a primary care service for providing smoking cessation advice. This will require education relevant to the needs of a range of health professionals, provision of and support for the implementation of clinical practice guidelines, access for patients to smoking cessation pharmacotherapies and integration with other cessation services such as quitlines.

Smoking and its correlates in an Australian prisoner population.

Despite evidence of high rates of smoking among prisoners, there has been limited research that describes smoking patterns and risk factors associated with smoking in this group. This study describes inmate smokers and identifies factors associated with smoking in prison, using a survey comprising a cross-sectional random sample of inmates stratified by sex, age and Aboriginality. A total of 914 adult inmates (747 men, 167 women) were recruited from 29 New South Wales (Australia) correctional centres. Information on the prevalence of smoking, smoking history, smoking behaviours and other risk factors were collected. Of the participants, 79% were current smokers (78% men, 83% women). Younger inmates were more likely than older inmates to smoke (86% vs. 64%). Most individuals smoked between 11 and 20 cigarettes a day and a median of 50 grams per week. In the previous year, over half (52%) of current smokers had attempted to quit or reduce the amount they smoked. At the time of the survey, 58% of smokers had plans to quit; 21% within 3 months. Independent predictors of current smoking in the multivariate analysis were past use of cannabis and a history of illicit drug use. The prevalence of smoking in prison is extraordinarily high and exceeds that of the general community. Despite this, the majority of prisoners report plans to quit. Readily available smoking cessation advice, support and treatment are needed to assist those wanting to quit in this stressful environment. As the prevalence of smoking within the general community declines, assisting cessation in groups containing a disproportionate number of smokers will become increasingly important. Despite high levels of tobacco dependence, many prisoners intend to quit and health planners and custodial authorities need to encourage and support inmates who do attempt to quit.

The role of remote community stores in reducing the harm resulting from tobacco to Aboriginal people.

The objective of this study was to assess the potential for reducing the harm resulting from tobacco use through health promotion programmes run in community stores in remote Aboriginal communities. The Tobacco Project utilised data from 111 stakeholder interviews (72 at baseline and 71 at follow-up after 12 months) assessing presence of sales to minors, tobacco advertising, labelling and pricing. It also involved the assessment of observational data from community stores and comments obtained from 29 tobacco vendors derived from community surveys. Sales of tobacco to minors were not reported in community stores and all stores complied with requirements to display the legislated signage. However, tobacco was accessible to minors through a vending machine and through independent vendors. Only one store displayed tobacco advertising; all stores had displayed anti-tobacco health promotion posters or pamphlets. Pricing policies in two stores may have meant that food items effectively subsidised the cost of tobacco. All stores had unofficial no-smoking policies in accessible parts of the store. Remote community stores complied with existing legislation, aside from allowing access of minors to vending machines. There may still be potential for proactive tobacco education campaigns run through community stores and for a trial assessing the effect of changes in tobacco prices on tobacco consumption.

Age-associated differences on structural brain MRI in nondemented individuals from 71 to 103 years.

Successful brain aging in the oldest old (≥90 years) is underexplored. This study examined cross-sectional brain morphological differences from 8th to 11th decades of life in nondemented individuals by high-resolution magnetic resonance imaging. Two hundred seventy-seven nondemented community-dwelling participants (71-103 years) from Sydney Memory and Ageing Study and Sydney Centenarian Study comprised the sample, including a subsample of 160 cognitively high-functioning elders. Relationships between age and magnetic resonance imaging-derived measurements were studied using general linear models; and structural profiles of the ≥90 years were delineated. In full sample and the subsample, significant linear negative relationship of gray matter with age was found, with the greatest age effects in the medial temporal lobe and parietal and occipital cortices. This pattern was further confirmed by comparing directly the ≥90 years to the 71-89 years groups. Significant quadratic age effects on total white matter and white matter hyperintensities were observed. Our study demonstrated heterogeneous differences across brain regions between the oldest old and young old, with an emphasis on hippocampus, temporoposterior cortex, and white matter hyperintensities.