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1.
Psychol Med ; 53(3): 687-695, 2023 02.
Artigo em Inglês | MEDLINE | ID: mdl-33966686

RESUMO

BACKGROUND: Young people may have elevated risk for poorer mental health during the coronavirus disease 2019 (COVID-19) pandemic, yet longitudinal studies documenting this impact are lacking. This study assessed changes in mental health and help-seeking since COVID-19 restrictions in young Australians, including gender differences. METHODS: Data were drawn from a recent subsample (n = 443; 60% female; Mage = 22.0) of a prospective cohort originally recruited in secondary school to complete annual surveys. The subsample completed an additional COVID-19 survey during COVID-19 restrictions (May-June 2020), which was compared to responses from their latest annual survey (August 2019-March 2020). Mixed effect models with time and gender as the primary predictors were conducted for: (i) scores on the Patient Health Questionnaire Depression 9-item (PHQ-9) and Generalised Anxiety Disorder 7-item (GAD-7) modules assessed before and during COVID-19 restrictions, and (ii) self-reported help-seeking from a health professional in February 2020, and the month preceding May-June 2020. RESULTS: Mean symptom scores increased from before to during COVID-19 restrictions on the PHQ-9 (coefficient: 1.29; 95% CI 0.72-1.86) and GAD-7 (0.78; 95% CI 0.26-1.31), but there was no increase in help-seeking over time (odds ratio 0.50; 95% CI 0.19-1.32). There was no evidence of differential changes by gender. CONCLUSIONS: This study found increases in depression and anxiety symptoms but not greater help-seeking among young Australian adults during the first wave of the pandemic. Increasing availability and awareness of accessible treatment options and psychoeducation is critical, as well as further research into risk and protective factors to help target treatment to this vulnerable age group.


Assuntos
COVID-19 , Saúde Mental , Adulto , Feminino , Humanos , Masculino , Adulto Jovem , Ansiedade/epidemiologia , Austrália/epidemiologia , Depressão/epidemiologia , Pandemias , Estudos Prospectivos
2.
JAMA ; 326(1): 56-64, 2021 07 06.
Artigo em Inglês | MEDLINE | ID: mdl-34228066

RESUMO

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.


Assuntos
Alcaloides/uso terapêutico , Agentes de Cessação do Hábito de Fumar/uso terapêutico , Abandono do Hábito de Fumar/métodos , Vareniclina/uso terapêutico , Adulto , Alcaloides/efeitos adversos , Azocinas/efeitos adversos , Azocinas/uso terapêutico , Sonhos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Náusea/induzido quimicamente , Quinolizinas/efeitos adversos , Quinolizinas/uso terapêutico , Agentes de Cessação do Hábito de Fumar/efeitos adversos , Resultado do Tratamento , Vareniclina/efeitos adversos
3.
Nicotine Tob Res ; 20(3): 276-285, 2018 02 07.
Artigo em Inglês | MEDLINE | ID: mdl-28034998

RESUMO

Aims: To assess the methodological quality and effectiveness of technology-based smoking cessation interventions in disadvantaged groups. Method: Four databases (EMBASE, Cochrane, Medline, and PsycInfo) were searched for studies conducted from 1980 to May 2016. Randomized controlled trials that compared a behavioral smoking cessation intervention delivered primarily through a technology-based platform (eg, mobile phone) with a no-intervention comparison group among disadvantaged smokers were included. Three reviewers assessed all relevant studies for inclusion, and one reviewer extracted study, participant and intervention-level data, with a subset crosschecked by a second reviewer. Results: Thirteen studies targeting disadvantaged smokers (n =4820) were included. Only one study scored highly in terms of methodological rigor on EPOC criteria for judging risk of bias. Of the 13 studies using a technology-based platform, most utilized websites (n = 5) or computer programs (n = 5), and seven additionally offered nicotine replacement therapy. Technology-based interventions increased the odds of smoking cessation for disadvantaged groups at 1 month (odds ratio [OR] 1.70, 95% confidence interval [CI] 1.10, 2.63), 3 months (OR 1.30, 95% CI 1.07, 1.59), 6 months (OR 1.29, 95% CI 1.03, 1.62), and 18 months post-intervention (OR 1.83, 95% CI 1.11, 3.01). Conclusion: Few methodologically rigorous studies were identified. Mobile phone text-messaging, computer- and website-delivered quit support showed promise at increasing quit rates among Indigenous, psychiatric and inpatient substance use disorder patients. Further research is needed to address the role technology-based interventions have on overcoming health inequalities to meet the needs of disadvantaged groups. Implications: This review provides the first quantitative evidence of the effectiveness of a range of technology-based smoking cessation interventions among disadvantaged smokers, with separate estimates on the basis of intervention type, and cessation outcome measure. Providing cost-effective, easily accessible and real-time smoking cessation treatment is needed, and innovative technology-based platforms will help reach this endpoint. These interventions need to be tested in larger scale randomized controlled trial designs and target broader disadvantaged groups. Data collection beyond 6 months is also needed in order to establish the efficacy of these intervention approaches on long-term cessation rates among disadvantaged population groups.


Assuntos
Abandono do Hábito de Fumar/métodos , Abandono do Hábito de Fumar/psicologia , Terapia Assistida por Computador/métodos , Dispositivos para o Abandono do Uso de Tabaco , Populações Vulneráveis/psicologia , Telefone Celular/economia , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Fumantes/psicologia , Abandono do Hábito de Fumar/economia , Software/economia , Envio de Mensagens de Texto/economia , Terapia Assistida por Computador/economia , Dispositivos para o Abandono do Uso de Tabaco/economia , Resultado do Tratamento
4.
Int J Equity Health ; 16(1): 196, 2017 11 13.
Artigo em Inglês | MEDLINE | ID: mdl-29132364

RESUMO

BACKGROUND: The social gradient in smoking rates persist with an overrepresentation of smoking and its associated harms concentrated within lower socioeconomic status (SES) populations. Low-SES smokers are motivated to quit but face multiple barriers when engaging a quit attempt. An understanding of the current treatment service model from the perspectives of treatment-seeking low-SES smokers is needed to inform the design of alternative smoking cessation support services tailored to the needs of low-SES populations. This qualitative study aimed to: i) explore low-SES smokers' recent quitting experiences; ii) assess factors that impact treatment engagement; and iii) determine the acceptability and feasibility of alternative approaches to smoking cessation. METHOD: Low-SES participants (n = 24) previously enrolled in a smoking cessation RCT participated in either a semi-structured focus group or in-depth telephone interview. Data was obtained and analysed using thematic analysis from October 2015 to June 2016. Analysis was deductive from the interview guide and supplemented inductively. RESULTS: Participants expressed feelings of guilt and shame around their smoking behaviour and experienced stigmatisation for their smoking. Guilt, shame, and stigmatisation negatively impacted treatment seeking behaviours with most avoiding current quit services. Costs of pharmacotherapy and treatment adherence were commonly cited barriers to treatment success. Electronic-cigarettes were perceived to be unsafe due to uncertainty on their legal status and regulatory restrictions. Technology-based text-messaging quit support was endorsed as a more favourable alternative compared to existing behavioural treatment services. CONCLUSION: Stigmatisation was commonly endorsed and acted as an impediment to current treatment utilisation. Electronic-cigarettes may present a viable harm reduction alternative, but their likely uptake in socioeconomically disadvantaged groups in Australia is limited by smokers' uncertainty about their regulation and legality. Mobile phone based cessation support may provide an alternative to telephone counselling and overcome the stigmatisation low-SES smokers face while trying to quit.


Assuntos
Atitude Frente a Saúde , Motivação , Fumantes/psicologia , Abandono do Hábito de Fumar/métodos , Abandono do Hábito de Fumar/psicologia , Classe Social , Adulto , Idoso , Austrália , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Pesquisa Qualitativa , Fatores Socioeconômicos
5.
Trials ; 23(1): 777, 2022 Sep 14.
Artigo em Inglês | MEDLINE | ID: mdl-36104702

RESUMO

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.


Assuntos
Alcoolismo , Abandono do Hábito de Fumar , Austrália , Análise Custo-Benefício , Humanos , Nicotina/efeitos adversos , Ensaios Clínicos Controlados Aleatórios como Assunto , Abandono do Hábito de Fumar/métodos , Classe Social , Nicotiana , Dispositivos para o Abandono do Uso de Tabaco/efeitos adversos , Resultado do Tratamento
6.
Drug Alcohol Depend ; 237: 109533, 2022 08 01.
Artigo em Inglês | MEDLINE | ID: mdl-35752023

RESUMO

BACKGROUND: Supply of alcohol to adolescents is associated with increased alcohol consumption and harms including alcohol use disorder (AUD). We aimed to identify: (1) trajectories of alcohol supply to adolescents; (2) sociodemographic characteristics associated with supply trajectory; (3) patterns of alcohol consumption by supply trajectory; and (4) supply trajectory associations with adverse alcohol outcomes. METHODS: We used Australian longitudinal survey data (N = 1813) to model latent trajectories of parent and peer alcohol supply over five annual follow-ups (Waves 2-6; Mage 13.9-17.8 years). Regression models assessed associations between supply trajectories and Wave 1 (Mage=12.9 years) sociodemographic factors and associations between supply trajectories and Wave 7 (Mage=18.8 years) alcohol outcomes. RESULTS: We identified five alcohol supply classes: (1) minimal supply (n = 739, 40.8%); (2) early parent sips, late peer/parent whole drinks (n = 254, 14.0%); (3) late peer/parent whole drinks (n = 419, 23.1%); (4) early parent sips, mid peer/parent whole drinks (n = 293, 16.2%); (5) early peer/parent whole drinks (n = 108, 6.0%). Compared to minimal supply, the other classes were 2.7-12.9 times as likely to binge drink, 1.6-3.0 times as likely to experience alcohol-related harms, and 2.1-8.6 times as likely to report AUD symptoms at age 19. CONCLUSION: Earlier supply of whole drinks, particularly from peers, was associated with increased risk of early adulthood adverse alcohol outcomes. While minimal supply represented the lowest risk, supplying sips only in early-mid adolescence and delaying supply of whole drinks until late adolescence is likely to be less risky than earlier supply of whole drinks.


Assuntos
Alcoolismo , Consumo de Álcool por Menores , Adolescente , Adulto , Consumo de Bebidas Alcoólicas/epidemiologia , Austrália/epidemiologia , Humanos , Estudos Longitudinais , Pais , Estudos Prospectivos , Adulto Jovem
7.
Addiction ; 115(11): 2140-2147, 2020 11.
Artigo em Inglês | MEDLINE | ID: mdl-32141130

RESUMO

AIMS: Despite legal age limits set for alcohol consumption, parents are one of the main suppliers of alcohol to underage minors. Although supply from non-parental sources has been found to be associated with greater risk of harm compared with parental supply, the association between parental supply and supply from other sources is unclear. This study investigated the associations between parental supply of sips and whole serves of alcohol on subsequent other supply, conditional on current supply from non-parental sources. METHODS: Data from the Australian Parental Supply of Alcohol Longitudinal Study cohort of adolescents was used. A cohort of 1927 Australian children recruited in grade 7 (mean age 12.9 years) was surveyed annually from 2010 to 2016 (94%, n = 1821 included for analyses). The primary outcome was alcohol exposure from other sources ('other supply'), including alcohol supply from other adults, friends, siblings, or self-supply, compared with adolescents reporting no supply from these sources. Analyses were conducted using random intercept logistic regression (to account for within-respondent correlation). RESULTS: Parental supply of alcohol alone was associated with increased odds of receiving alcohol from other non-parental sources in subsequent years (OR: 1.99; 95% CI: 1.65-2.39) after adjusting for confounders. Increased odds of subsequent other supply were associated with current parental supply of sips (OR: 1.92; 95% CI: 1.56-2.36) and whole drinks (OR: 2.76; 95% CI: 1.85-4.11). CONCLUSIONS: Parental supply of alcohol appears to increase the risk of subsequent supply of alcohol from other sources in certain contexts.


Assuntos
Bebidas Alcoólicas/estatística & dados numéricos , Relações Pais-Filho , Pais , Consumo de Álcool por Menores/estatística & dados numéricos , Adolescente , Adulto , Austrália/epidemiologia , Criança , Estudos de Coortes , Feminino , Amigos , Humanos , Modelos Logísticos , Estudos Longitudinais , Masculino , Estudos Prospectivos , Irmãos , Inquéritos e Questionários
8.
Drug Alcohol Depend ; 215: 108204, 2020 10 01.
Artigo em Inglês | MEDLINE | ID: mdl-32871506

RESUMO

BACKGROUND: Parents frequently supply alcohol to their children, often only sips. We investigated whether supply of sips and whole drinks, from parents and other sources, are differentially associated with subsequent drinking outcomes. METHODS: A cohort of 1910 adolescents (mean age 12.9yrs) were surveyed annually over seven years from 2010-11. We examined prospective, adjusted associations between the quantity of supply from parental and non-parental sources in the preceding 12 months and five outcomes in the subsequent year, over several consecutive years: binge drinking; alcohol-related harms; symptoms of alcohol abuse, dependence and alcohol use disorder (AUD). RESULTS: In early waves, most parental supply comprised sips, while supply of whole drinks increased in later waves. Among those not receiving alcohol from other sources, parental supply of sips was associated with increased odds of binge drinking (OR: 1.85; 99.5 % CI: 1.17-2.91) and alcohol-related harms (OR: 1.70; 99.5 % CI: 1.20-2.42), but not with reporting symptoms of alcohol abuse, dependence or AUD, compared with no supply. Relative to no supply, supply of sips from other sources was associated with increased odds of binge drinking (OR: 2.04; 99.5 % CI: 1.14-3.67) only. Compared with supply of sips, supply of whole drinks by parents or others had higher odds of binge drinking, alcohol-related harms, symptoms of dependence and of AUD. Secondary analysis demonstrated that supply of larger quantities was associated with an increased risk of all outcomes. CONCLUSION: Parental provision of sips is associated with increased risks and the supply of greater quantities was associated with an increasing risk of adverse outcomes. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov (NCT02280551).


Assuntos
Consumo de Bebidas Alcoólicas/epidemiologia , Consumo Excessivo de Bebidas Alcoólicas/epidemiologia , Consumo de Álcool por Menores/estatística & dados numéricos , Adolescente , Comportamento do Adolescente , Consumo de Bebidas Alcoólicas/efeitos adversos , Alcoolismo , Criança , Estudos de Coortes , Feminino , Alimentos , Humanos , Masculino , Pais , Estudos Prospectivos , Assunção de Riscos , Inquéritos e Questionários
9.
Drug Alcohol Depend ; 205: 107582, 2019 12 01.
Artigo em Inglês | MEDLINE | ID: mdl-31778903

RESUMO

BACKGROUND: Systematic reviews and meta-analyses (reviews) conflict regarding the efficacy and feasibility of substance disorder treatments for young people (YP). This overview of reviews, synthesizes, and methodologically assesses reviews examining substance disorder interventions for YP in outpatient settings. METHODS: Reviews published between 1990 and March 2018 were searched using EBM Reviews, PsycINFO, Embase, Ovid Medline, and Campbell Collaboration. Reviews investigating efficacy and/or feasibility of YP substance disorder treatments in outpatient settings were included. FORTY-THREE REVIEWS MET ALL INCLUSION CRITERIA: To appraise methodological biases, 40 reviews were assessed using A Measurement Tool to Assess Systematic Reviews 2 (AMSTAR2) and 3 were narratively assessed. One reviewer (NS) extracted study data and evaluated all 43 reviews. For inter-rater reliability, 13 (30%) reviews were extracted and appraised in duplicate by a second reviewer (JA, RC or ES). Agreement on AMSTAR2 ratings reached 100%. Agreement was moderate; κ = .52 (p < .05), 95% CI (.20, .84). RESULTS: All high quality methodological reviews (n = 6) focused on intervention efficacy and none on treatment feasibility. One (n = 1) high quality review reported evidence for an intervention. Multidimensional Family Therapy (MDFT) has possible efficacy in reducing YP substance use when compared to treatment as usual, Cognitive Behavior Therapy, Adolescent Community Reinforcement Approach and Multifamily Educational Therapy. CONCLUSIONS: Methodological and reporting quality of reviews require improvement. High quality reviews focused on intervention efficacy but treatments commonly lacked evidence. One high quality review found MDFT demonstrated promising outcomes. Reviews examining feasibility of interventions were of low methodological quality.


Assuntos
Pacientes Ambulatoriais/psicologia , Literatura de Revisão como Assunto , Transtornos Relacionados ao Uso de Substâncias/psicologia , Transtornos Relacionados ao Uso de Substâncias/terapia , Assistência Ambulatorial/métodos , Assistência Ambulatorial/psicologia , Terapia Cognitivo-Comportamental/métodos , Terapia Familiar/métodos , Humanos , Reprodutibilidade dos Testes , Resultado do Tratamento
10.
Addict Behav ; 89: 113-120, 2019 02.
Artigo em Inglês | MEDLINE | ID: mdl-30290299

RESUMO

AIMS: To examine factors associated with Quitline and pharmacotherapy utilisation in low socioeconomic status (low-SES) smokers enrolled in a smoking cessation trial. METHODS: Baseline data was used from a large-scale smoking cessation randomised controlled trial (RCT). Logistic regression models were used to examine predictors of treatment utilisation prior to entering the RCT and perceived effectiveness of past and future use. RESULTS: A total of 1047 smokers consented and prior to enrolment 92% had previously tried to quit smoking, 86% had ever used quit support, 83% had used pharmacotherapy at least once and 38% had ever utilised Quitline. For those who had used pharmacotherapies, 71% used NRT, of which 21% had used dual NRT products. In the last 12-months, 27% utilised Quitline and 50% utilised NRT. Ever use of Quitline was negatively associated with self-efficacy to quit (OR: 0.80; 95% CI: 0.68, 0.94 p < .01) and positively associated with being diagnosed with a mental health condition (OR: 1.50; 95% CI: 1.01, 2.25 p < .05). Recent use of NRT was positively associated with mental health condition (OR: 1.39; 95% CI: 1.02, 1.90 p < .05) and negatively associated with alcohol consumption (OR: 0.69; 95% CI: 0.52, 0.92 p < .01). CONCLUSION: Past use of Quitline and pharmacotherapy treatment was associated with self-efficacy to quit, sociodemographic variables, mental health conditions and alcohol consumption. Community-based strategies that target smoking, mental health and drug and alcohol problems may overcome some of the barriers that prevent low-SES populations from engaging with smoking cessation support.


Assuntos
Aceitação pelo Paciente de Cuidados de Saúde/estatística & dados numéricos , Pobreza/estatística & dados numéricos , Abandono do Hábito de Fumar/estatística & dados numéricos , Telemedicina/estatística & dados numéricos , Fumar Tabaco/terapia , Dispositivos para o Abandono do Uso de Tabaco/estatística & dados numéricos , Alcoolismo/complicações , Terapia Comportamental/estatística & dados numéricos , Aconselhamento/estatística & dados numéricos , Feminino , Humanos , Masculino , Transtornos Mentais/complicações , Pessoa de Meia-Idade , Fumantes , Abandono do Hábito de Fumar/métodos , Fatores Socioeconômicos , Desemprego/estatística & dados numéricos
11.
Addiction ; 114(5): 923-933, 2019 05.
Artigo em Inglês | MEDLINE | ID: mdl-30589984

RESUMO

BACKGROUND AND AIMS: Smoking cessation medications are effective, but often underutilized because of costs and side effects. Cytisine is a plant-based smoking cessation medication with more than 50 years of use in central and eastern Europe. While cytisine has been found to be well-tolerated and more effective than nicotine replacement therapy, direct comparisons with varenicline have not been conducted. This study evaluates the effectiveness, safety and cost-effectiveness of cytisine compared with varenicline. DESIGN: Two-arm, parallel group, randomized, non-inferiority trial, with allocation concealment and blinded outcome assessment. SETTING: Australian population-based study. PARTICIPANTS: Adult daily smokers (n = 1266) interested in quitting will be recruited through advertisements and Quitline telephone-based cessation support services. INTERVENTION AND COMPARATOR: Eligible participants will be randomized (1 : 1 ratio) to receive either cytisine capsules (25-day supply) or varenicline tablets (12-week supply), prescribed in accordance with the manufacturer's recommended dosing regimen. The medication will be mailed to each participant's nominated residential address. All participants will also be offered standard Quitline behavioural support (up to six 10-12-minute sessions). MEASUREMENTS: Assessments will be undertaken by telephone at baseline, 4 and 7 months post-randomization. Participants will also be contacted twice (2 and 4 weeks post-randomization) to ascertain adverse events, treatment adherence and smoking status. The primary outcome will be self-reported 6-month continuous abstinence from smoking, verified by carbon monoxide at 7-month follow-up. We will also evaluate the relative safety and cost-effectiveness of cytisine compared with varenicline. Secondary outcomes will include self-reported continuous and 7-day point prevalence abstinence and cigarette consumption at each follow-up interview. COMMENTS: If cytisine is as effective as varenicline, its lower cost and natural plant-based composition may make it an acceptable and affordable smoking cessation medication that could save millions of lives world-wide.


Assuntos
Alcaloides/economia , Alcaloides/uso terapêutico , Abandono do Hábito de Fumar/economia , Abandono do Hábito de Fumar/métodos , Vareniclina/economia , Vareniclina/uso terapêutico , Adulto , Alcaloides/efeitos adversos , Austrália , Azocinas/efeitos adversos , Azocinas/economia , Azocinas/uso terapêutico , Análise Custo-Benefício , Método Duplo-Cego , Estudos de Equivalência como Asunto , Feminino , Humanos , Masculino , Quinolizinas/efeitos adversos , Quinolizinas/economia , Quinolizinas/uso terapêutico , Resultado do Tratamento , Vareniclina/efeitos adversos
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