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INTRODUCTION: Little is known about the adverse events (AEs) of cytisine versus varenicline among individuals with mental health disorders (MHDs), highlighting the necessity for further exploration to inform clinical practice. This secondary analysis of clinical trial data aimed to investigate the effect of varenicline vs. cytisine regarding mental-health-related AEs (MH-related AEs) on smokers with and without MHDs. METHODS: Australian daily smokers interested in quitting were randomised to varenicline (84 days) or cytisine (25 days) and categorised by self-reported MHD diagnosis or treatment in the past year (MHD or non-MHD groups). Treatment adherence was assessed by self-reported number of doses taken during the active treatment phase via two check-in calls (at one month), while AEs were evaluated through four phone interviews: two check-in calls (one month) and follow-up calls at four and seven months. Logistic regression analysis compared MH-related AEs between groups, including only participants taking at least one dose. RESULTS: Of 1452 smokers 246 reported MHDs, 725 received cytisine and 727 received varenicline. Median number of doses taken was comparable between MHD (34 cytisine and 12 varenicline) and non-MHD (33 cytisine and 13 varenicline) groups. MH-related AEs were: 14.1 % (n = 30) in MHD (12.5 % in cytisine and 15.4 % in varenicline), and 11.8 % (n = 126) in non-MHD group (10.9 % in cytisine and 13.7 % in varenicline). No significant difference in MH-related AE occurrence was identified between medication groups (aOR=0.96, 95 % CI 0.4 to 2.2, p-value = 0.94). CONCLUSION: Comparable MH-related AEs were observed between smokers with and without MHDs, suggesting that cytisine, like varenicline, may be well-tolerated by those with MHDs. However, larger clinical trials focused on MH-related AEs are needed for more conclusive evidence.

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Brief interventions for smoking cessation, such as the 5As (ask, assess, advise, assist, arrange) are effective, but limited data are available regarding their delivery to smokers with mental health disorders (MHDs), and whether a disparity in care exists. This study explored the difference in the self-reported receipt of 5As between smokers with and without MHDs in a community setting. Baseline data from 1452 (1206 without and 246 with self-reported MHDs) Australian smokers who participated in a smoking cessation trial were analysed. Participants reported interactions with healthcare providers and receipt of the 5As over the past 12 months. Multivariate logistic regression analysis was employed to investigate the association between receipt of the 5As and MHD status. Smokers with MHDs were significantly more likely to be asked, assessed, advised, and assisted compared to those without MHDs, but arranging follow-up was very low in both groups (7.7% with MHDs and 4.1% without MHDs). This is particularly concerning for vulnerable population like smokers with MHDs, who may struggle more in their quit attempt. The findings highlight the need to enhance the implementation of the 'arrange follow-up' component to improve cessation outcomes and reduce health disparities.

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BACKGROUND: Prevention and early intervention of alcohol use disorder (AUD) is a public health priority, yet there are gaps in our understanding of how AUD emerges, which symptoms of AUD come first, and whether there are modifiable risk factors that forecast the development of the disorder. This study investigated potential early-warning-sign symptoms for the development of AUD. METHODS: Data were from the RADAR study, a prospective cohort study of contemporary emerging adults across Australia (n = 565, mean age = 18.9, range = 18-21 at baseline, 48% female). Participants were interviewed five times across a 2.5-year period. Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) AUD criteria and diagnoses were assessed by clinical psychologists using the Structured Clinical Interview for DSM-IV (SCID-IV), modified to cover DSM-5 criteria. Hazard analyses modeled the time from first alcoholic drink to the emergence of any AUD criteria and determined which first-emergent AUD criteria were associated with a faster transition to disorder. RESULTS: By the final time point, 54.8% of the sample had experienced at least one DSM-5 AUD criterion and 26.1% met criteria for DSM-5 AUD. The median time from first AUD criterion to a diagnosis of AUD was 4 years. Social problems from drinking (hazard ratio [HR] = 3.24, CI95 = 2.14, 4.92, p < 0.001), major role (HR = 2.53, CI95 = 1.58, 4.06, p < 0.001), and drinking larger amounts/for longer than intended (HR = 2.04, CI95 = 1.20, 3.46, p = 0.008) were first-onset criteria associated with a faster transition to AUD. CONCLUSION: In the context of a prospective general population cohort study of the temporal development of AUD, alcohol-related social problems, major role problems, and using more or for longer than intended are key risk factors that may be targeted for early intervention.

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BACKGROUND AND AIMS: Adolescent polysubstance use has been associated with adverse social and health outcomes. Our aim was to measure rates and transitions to polysubstance use during adolescence and identify factors associated with initiation and discontinuation of polysubstance use. DESIGN: Prospective cohort study. Multistate Markov modelling was used to estimate rates and identify correlates of transitions between substance use states. SETTING AND PARTICIPANTS: Adolescent-parent dyads (n = 1927; adolescents in grade 7, age ≈13 years) were recruited from Australian schools during 2010/11 (Wave 1). Adolescents were surveyed annually until 2016/17 (n = 1503; age ≈19 years; Wave 7) and parents were surveyed annually until 2014/15 (Wave 5). MEASUREMENTS: Alcohol, tobacco, cannabis and 3,4-methylenedioxymethamphetamine (MDMA) use outcomes were collected at Waves 3-7. Potential confounders were collected at Waves 1-6 and consisted of sex, anxiety and depression symptoms and externalizing problems, parental monitoring, family conflict and cohesion, parental substance use and peer substance use. Covariates were age and family socioeconomic status. FINDINGS: Few adolescents engaged in polysubstance use at earlier waves (Wave 3: 5%; Wave 4: 8%), but proportions increased sharply across adolescence (Waves 5-7: 17%, 24%, 36%). Rates of transitioning to polysubstance use increased with age, with few (<9%) adolescents transitioning out. More externalizing problems (odds ratio [OR] = 1.10; 99.6% confidence interval [CI] = 1.07-1.14), parental heavy episodic drinking (OR = 1.22; 99.6% CI = 1.07-1.40), parental illicit substance use (OR = 3.56; 99.6% CI = 1.43-8.86), peer alcohol use (OR = 5.68; 99.6% CI = 1.59-20.50) and peer smoking (OR = 4.18; 99.6% CI = 1.95-8.81) were associated with transitioning to polysubstance use. CONCLUSIONS: Polysubstance use in Australia appears to be rare during early adolescence but more common in later adolescence with low rates of transitioning out. Externalizing problems and greater parental and peer substance use are risk factors for adolescent polysubstance use that may be suitable intervention targets.

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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.

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OBJECTIVES: People suffering from mental health disorder (MHDs) are often under-represented in clinical research though the reasons for their exclusion are rarely recorded. As they have higher rates of smoking and nicotine dependence, it is crucial that they are adequately represented in clinical trials of established pharmacotherapy interventions for smoking cessation. This review aims to examine the practice of excluding smokers with MHDs and reasons for such exclusion in clinical trials evaluating pharmacotherapy treatments for smoking cessation. DATA SOURCE: The Cochrane database of systematic reviews was searched until September 2020 for reviews on smoking cessation using pharmacotherapies. STUDY SELECTION: Randomised controlled trials (RCTs) within the selected Cochrane reviews were included. DATA EXTRACTION: Conducted by one author and independently verified by three authors. DATA SYNTHESIS: We included 279 RCTs from 13 Cochrane reviews. Of all studies, 51 (18.3%) explicitly excluded participants with any MHDs, 152 (54.5%) conditionally excluded based on certain MHD criteria and 76 (27.2%) provided insufficient information to ascertain either inclusion or exclusion. Studies of antidepressant medications used for smoking cessation were found to be 3.33 times more likely (95% CI 1.38 to 8.01, p=0.007) to conditionally exclude smokers with MHDs than explicitly exclude compared with studies of nicotine replacement therapy. CONCLUSION: Smokers with MHDs are not sufficiently represented in RCTs examining the safety and effectiveness of smoking cessation medications. Greater access to clinical trial participation needs to be facilitated for this group to better address access to appropriate pharmacotherapeutic interventions in this vulnerable population.

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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.

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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.

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BACKGROUND: Different forms of alcohol-related harm (e.g., hangovers, fighting) may confer differential risk of clinically relevant alcohol problems. We examine: (i) patterns of transition in experiencing alcohol-related harms across adolescence; (ii) whether factors in early adolescence predict transition patterns; and (iii) whether transition patterns predict later alcohol use disorder (AUD) symptoms. METHODS: We used a longitudinal Australian cohort (n = 1828) to model latent class transition patterns of alcohol-related harms across three timepoints (Mage  = 13.9, 16.8, 18.8 years). Regression models assessed whether child, peer, and parent factors in early adolescence (Mage  = 12.9) predicted harms transition patterns and whether these patterns predicted AUD symptoms in early adulthood (Mage  = 19.8). RESULTS: Five transition patterns characterized most of the cohort (n ≈ 1609, 88.0%): (i) minimal harms (n ≈ 381, 20.8%); (ii) late physiological harms (n ≈ 702, 38.4%); (iii) early physiological harms (n ≈ 226, 12.4%); (iv) late all harms (n ≈ 131, 7.2%); and (v) gradual all harms (n ≈ 169, 9.2%). With late physiological harms as the reference, females had increased risk of experiencing early physiological harms (relative risk [RR]: 2.15; 99.5% CI: 1.19, 3.90). Late all harms (RR: 1.71; CI: 1.19, 2.47) and gradual all harms (RR: 1.84; CI: 1.37, 2.47) were each associated with increased odds of meeting criteria for AUD, even when patterns of alcohol consumption are considered. CONCLUSIONS: Adolescents display heterogeneous transition patterns across physiological and psychosocial alcohol-related harms. Females are at greater risk of experiencing early physiological harms. Experience of both physiological and psychosocial harms in late adolescence is an important and potentially modifiable precursor to clinically relevant alcohol problems in early adulthood.

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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.

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BACKGROUND AND AIMS: Experience of alcohol-induced memory blackouts in adolescence may be an important risk factor for later harms. This longitudinal study (i) modelled trajectories of alcohol-related blackouts throughout adolescence, (ii) explored early-adolescent predictors of blackout trajectories and (iii) examined the association between blackout trajectories and alcohol use disorder (AUD) symptoms. DESIGN: Longitudinal study in which data from six annual surveys of a longitudinal cohort of Australian adolescents were used to model latent class growth trajectories of blackouts, adjusting for alcohol consumption frequency and typical quantity. Regression models were used to determine whether parent, child and peer factors at baseline (mean age = 12.9) predicted profiles of blackout trajectory membership and whether blackout trajectories predicted meeting criteria for AUD in early adulthood (mean age = 19.8). SETTING AND PARTICIPANTS: Australian adolescents (n = 1821; mean age = 13.9-18.8 years). MEASUREMENTS: Alcohol-related blackouts, alcohol consumption frequency, typical consumption quantity and DSM-5 AUD in early adulthood were all self-reported. FINDINGS: We identified a three-class solution: delayed alcohol initiation, rare blackouts (n = 701; 38.5%); early initiation, rare blackouts (n = 869; 47.7%); and early initiation, increasing blackouts (n = 251; 13.8%). Female sex was associated with increased risk of early initiation, increasing blackouts relative to delayed initiation, rare blackouts [relative risk ratio (RRR) = 3.90; 99.5% confidence interval (CI) = 1.96, 7.76] and relative to early initiation, rare blackouts (RRR = 2.89; 99.5% CI = 1.42, 5.87). Early initiation, rare blackouts [odds ratio (OR) = 1.96; 99.5% CI = 1.17, 3.29] and early initiation, increasing blackouts (OR = 4.93; 99.5% CI = 2.32, 10.48) were each associated with increased odds of meeting criteria for AUD in early adulthood relative to delayed initiation, rare blackouts. Early initiation, increasing blackouts was associated with increased odds of meeting criteria for AUD in early adulthood relative to early initiation, rare blackouts (OR = 2.51; 99.5% CI = 1.18, 5.38). CONCLUSIONS: Females in Australia appear to be at higher risk of adolescent alcohol-related blackouts independent of alcohol consumption levels and age of initiation. Alcohol-related blackouts may be associated with later alcohol use disorder.

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OBJECTIVES: Adolescents often display heterogenous trajectories of alcohol use. Initiation and escalation of drinking may be important predictors of later harms, including alcohol use disorder (AUD). Previous conceptualizations of these trajectories lacked adjustment for known confounders of adolescent drinking, which we aimed to address by modeling dynamic changes in drinking throughout adolescence while adjusting for covariates. METHODS: Survey data from a longitudinal cohort of Australian adolescents (n = 1813) were used to model latent class alcohol use trajectories over 5 annual follow-ups (mean age = 13.9 until 17.8 years). Regression models were used to determine whether child, parent, and peer factors at baseline (mean age = 12.9 years) predicted trajectory membership and whether trajectories predicted self-reported symptoms of AUD at the final follow-up (mean age = 18.8 years). RESULTS: We identified 4 classes: abstaining (n = 352); late-onset moderate drinking (n = 503); early-onset moderate drinking (n = 663); and early-onset heavy drinking (n = 295). Having more alcohol-specific household rules reduced risk of early-onset heavy drinking compared with late-onset moderate drinking (relative risk ratio: 0.31; 99.5% confidence interval [CI]: 0.11-0.83), whereas having more substance-using peers increased this risk (relative risk ratio: 3.43; 99.5% CI: 2.10-5.62). Early-onset heavy drinking increased odds of meeting criteria for AUD in early adulthood (odds ratio: 7.68; 99.5% CI: 2.41-24.47). CONCLUSIONS: Our study provides evidence that parenting factors and peer influences in early adolescence should be considered to reduce risk of later alcohol-related harm. Early initiation and heavy alcohol use throughout adolescence are associated with increased risk of alcohol-related harm compared with recommended maximum levels of consumption (late-onset, moderate drinking).

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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).

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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.

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BACKGROUND AND AIMS: Recent research suggests that parental supply of alcohol is associated with more risky drinking and alcohol-related harm among adolescents. However, the overall effect of parental supply throughout adolescence remains unclear, because parental supply of alcohol varies during adolescence. Due to the complexity of longitudinal data, standard analytical methods can be biased. This study examined the effect of parental supply of alcohol on alcohol-related outcomes in early adulthood using robust methods to minimize risk of bias. DESIGN: Prospective longitudinal cohort study. SETTING: Australia PARTICIPANTS: A cohort of school students (n = 1906) recruited in the first year of secondary school (average age 12.9 years) from Australian schools in 2010-11, interviewed annually for 7 years. MEASUREMENTS: The exposure variable was self-reported parental supply of alcohol (including sips/whole drinks) during 5 years of adolescence (waves 1-5). Outcome variables were self-reported binge drinking, alcohol-related harm and symptoms of alcohol use disorder, measured in the two waves after the exposure period (waves 6-7). To reduce risk of bias, we used targeted maximum likelihood estimation to assess the (counterfactual) effect of parental supply of alcohol in all five waves versus no supply on alcohol-related outcomes. FINDINGS: Parental supply of alcohol throughout adolescence saw greater risk of binge drinking [risk ratios (RR) = 1.53; 95% confidence interval (CI) = 1.27-1.84] and alcohol-related harms (RR = 1.44; 95% CI = 1.22-1.69) in the year following the exposure period compared with no supply in adolescence. Earlier initiation of parental supply also increased risk of binge drinking (RR = 1.10; 95% CI = 1.05-1.14), and any alcohol-related harm (RR = 1.09; 95% CI = 1.05-1.13) for each year earlier parental supply began compared with later (or no) initiation. CONCLUSIONS: Adolescents whose parents supply them with alcohol appear to have an increased risk of alcohol-related harm compared with adolescents whose parents do not supply them with alcohol. The risk appears to increase with earlier initiation of supply.

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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.

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BACKGROUND: Recent research has not supported the idea that parental supply of alcohol to adolescents prevents later alcohol-related harm. Yet the specific role of parental supply in shaping patterns of drinking over time remains unclear. This study investigated the role of parental supply of alcohol in patterns of drinking across adolescence, and assessed whether that role remained consistent over time. METHOD: Using a longitudinal cohort of 1927 adolescents (mean age 12.9 years), recruited in 2010 and 2011 from schools across Australia and followed up annually until 2016, we assessed three outcomes using mixed-effect negative binomial regression: frequency of consumption, typical quantity consumed, and overall alcohol consumption in the year (frequency * quantity). Child, parental, familial, and peer confounders of adolescent alcohol consumption were measured and adjusted for in the analyses. FINDINGS: Parental supply was associated with greater overall consumption in earlier adolescence: Grade 7-8 (incidence rate ratio [IRR]: 3.61; 95% CI: 2.55, 5.12; no supply IRR: 1.00), Grade 8-9 (IRR: 4.84; 95% CI: 3.66, 6.39; no supply IRR: 1.44) and Grade 9-10 (IRR: 8.33; 95% CI: 6.28, 11.05; no supply IRR: 4.75). Alcohol consumption continued to increase in later adolescence regardless of whether parental supply occurred. CONCLUSIONS: Parental supply of alcohol was associated with increased alcohol consumption by their children during early adolescence. While parental supply appears to have less impact on drinking in later adolescence, there was no evidence to suggest it is protective. Parents should be advised to avoid supplying children with alcohol, particularly in early adolescence.

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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.

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