Melbourne School of Psychological Sciences - Research Publications
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ItemElectronic nicotine devices to aid smoking cessation by alcohol- and drug-dependent clients: protocol for a pilot randomised controlled trial(BMC, 2018-08-02)BACKGROUND: Up to 95% of people entering treatment for use of alcohol or other drugs (AOD) smoke tobacco. Smokers receiving treatment for AOD use are interested in quitting and make quit attempts, but relapse is more common and rapid compared with the general population of smokers. New ways to address smoking in this population are needed. Electronic nicotine devices (ENDs) or electronic cigarettes hold significant potential as both cessation aids and harm reduction support. This study focuses on the potential of ENDs to facilitate smoking cessation and to sustain it in the medium term among people in treatment for AOD use. The aim of this trial is to explore the effectiveness, feasibility and acceptability of ENDs for smoking cessation compared with combination nicotine replacement therapy (NRT) for clients after discharge from a smoke-free AOD residential withdrawal service. METHODS/DESIGN: The study is a pragmatic randomised controlled trial. In total, 100 participants will be recruited following admission to a smoke-free residential withdrawal service in Melbourne, Australia. Participants will complete a baseline survey and be randomised to either the END group (n = 50) or the NRT group (n = 50) prior to discharge. Both groups will receive telephone counselling support from quitline. Follow-up measures will be assessed at 6 and 12 weeks following discharge. The primary outcome is continuous abstinence from smoking at 12 weeks post discharge. Secondary outcomes include: 7-day point prevalence from smoking, point prevalence abstinence from all nicotine (including NRT and ENDs), cravings and withdrawal, time to relapse, and treatment adherence (use of NRT, ENDs and quitline). DISCUSSION: This is the first randomised controlled trial to assess the effectiveness and acceptability of ENDs within a population dependent on AOD, a priority group with very high levels of smoking. The research will test a model of how to incorporate novel smoking cessation support into a period of high treatment receptiveness. TRIAL REGISTRATION: Australian New Zealand Clinical Trial Registry, ACTRN12617000849392 . Registered on 8 June 2017.
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ItemQuitNic: A Pilot Randomized Controlled Trial Comparing Nicotine Vaping Products With Nicotine Replacement Therapy for Smoking Cessation Following Residential Detoxification(OXFORD UNIV PRESS, 2021-03)INTRODUCTION: The QuitNic pilot trial aimed to test the feasibility of providing a nicotine vaping product (NVP) compared with combination nicotine replacement therapy (NRT) to smokers upon discharge from a smoke-free residential substance use disorder (SUD) treatment service. METHODS: QuitNic was a pragmatic two-arm randomized controlled trial. At discharge from residential withdrawal, 100 clients received telephone Quitline behavioral support and either 12-week supply of NRT or an NVP. Treatment adherence and acceptability, self-reported abstinence, cigarettes smoked per day (CPD), frequency of cravings, and severity of withdrawal symptoms were assessed at 6 and 12 weeks. Results are reported for complete cases and for abstinence outcomes, penalized imputation results are reported where missing is assumed smoking. RESULTS: Retention on was 63% at 6 weeks and 50% at 12 weeks. At 12 weeks, 68% of the NRT group reported using combination NRT while 96% of the NVP group used the device. Acceptability ratings for the products were high in both groups. At 12 weeks, 14% of the NVP group and 18% of the NRT group reported not smoking at all in the last 7 days. Mean CPD among continued smokers decreased significantly between baseline to 12 weeks in both groups; from 19.91 to 4.72 for the NVP group (p < .001) and from 20.88 to 5.52 in the NRT group (p < .001). Cravings and withdrawal symptoms significantly decreased for both groups. CONCLUSIONS: Clients completing residential withdrawal readily engaged with smoking cessation post-treatment when given the opportunity. Further research is required to identify the most effective treatments postwithdrawal for this population at elevated risk of tobacco-related harm. TRIAL REGISTRATION NUMBER: ACTRN12617000849392. IMPLICATIONS: This pilot study showed that smoking cessation support involving options for nicotine replacement and Quitline-delivered cognitive behavioral counseling is attractive to people after they have been discharged from SUD treatment. Both nicotine vaping products and nicotine replacement therapies were highly acceptable and used by participants who reported reductions in cravings for cigarettes and perceptions of withdrawal symptoms and reductions in number of cigarettes smoked. Some participants self-reported abstinence from cigarettes-around one in five reported having quit smoking cigarettes at 12 weeks postdischarge. The results have significant public health implications for providing quit support following discharge from SUD treatment.
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Item"Quitlink"-A Randomized Controlled Trial of Peer Worker Facilitated Quitline Support for Smokers Receiving Mental Health Services: Study Protocol(FRONTIERS MEDIA SA, 2019-03-19)Introduction: Although smokers with severe mental illnesses (SSMI) make quit attempts at comparable levels to other smokers, fewer are successful in achieving smoking cessation. Specialized smoking cessation treatments targeting their needs can be effective but have not been widely disseminated. Telephone delivered interventions, including by quitlines, show promise. However, few SSMI contact quitlines and few are referred to them by health professionals. Mental health peer workers can potentially play an important role in supporting smoking cessation. This study will apply a pragmatic model using peer workers to engage SSMI with a customized quitline service, forming the "Quitlink" intervention. Methods: A multi-center prospective, cluster-randomized, open, blinded endpoint (PROBE) trial. Over 3 years, 382 smokers will be recruited from mental health services in Victoria, Australia. Following completion of baseline assessment, a brief intervention will be delivered by a peer worker. Participants will then be randomly allocated either to no further intervention, or to be referred and contacted by the Victorian Quitline and offered a targeted 8-week cognitive behavioral intervention along with nicotine replacement therapy (NRT). Follow-up measures will be administered at 2-, 5-, and 8-months post-baseline. The primary outcome is 6 months continuous abstinence from end of treatment with biochemical verification. Secondary outcomes include 7-day point prevalence abstinence from smoking, increased quit attempts, and reductions in cigarettes per day, cravings and withdrawal, mental health symptoms, and other substance use, and improvements in quality of life. We will use a generalized linear mixed model (linear regression for continuous outcomes and logistic regression for dichotomous outcomes) to handle clustering and the repeated measures at baseline, 2-, 5-, and 8-months; individuals will be modeled as random effects, cluster as a random effect, and group assignment as a fixed effect. Discussion: This is the first rigorously designed RCT to evaluate a specialized quitline intervention accompanied by NRT among SSMI. The study will apply a pragmatic model to link SSMI to the Quitline, using peer workers, with the potential for wide dissemination. Clinical Trial Registration: Trial Registry: The trial is registered with ANZCTR (www.anzctr.org.au): ACTRN12619000244101 prior to the accrual of the first participant and updated regularly as per registry guidelines. Trial Sponsor: University of Newcastle, NSW, Australia.
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ItemThe study protocol for a randomized controlled trial of a family-centred tobacco control program about environmental tobacco smoke (ETS) to reduce respiratory illness in Indigenous infants(BMC, 2010-03-07)BACKGROUND: Acute respiratory illness (ARI) is the most common cause of acute presentations and hospitalisations of young Indigenous children in Australia and New Zealand (NZ). Environmental tobacco smoke (ETS) from household smoking is a significant and preventable contributor to childhood ARI. This paper describes the protocol for a study which aims to test the efficacy of a family-centred tobacco control program about ETS to improve the respiratory health of Indigenous infants in Australia and New Zealand. For the purpose of this paper 'Indigenous' refers to Australia's Aboriginal and Torres Strait Islander peoples when referring to Australian Indigenous populations. In New Zealand, the term 'Indigenous' refers to Māori. METHODS/DESIGN: This study will be a parallel, randomized, controlled trial. Participants will be Indigenous women and their infants, half of whom will be randomly allocated to an 'intervention' group, who will receive the tobacco control program over three home visits in the first three months of the infant's life and half to a control group receiving 'usual care' (i.e. they will not receive the tobacco control program). Indigenous health workers will deliver the intervention, the goal of which is to reduce or eliminate infant exposure to ETS. Data collection will occur at baseline (shortly after birth) and when the infant is four months and one year of age. The primary outcome is a doctor-diagnosed, documented case of respiratory illness in participating infants. DISCUSSION: Interventions aimed at reducing exposure of Indigenous children to ETS have the potential for significant benefits for Indigenous communities. There is currently a dearth of evidence for the effect of tobacco control interventions to reduce children's exposure to ETS among Indigenous populations. This study will provide high-quality evidence of the efficacy of a family-centred tobacco control program on ETS to reduce respiratory illness. Outcomes of our study will be important and significant for Indigenous tobacco control in Australia and New Zealand and prevention of respiratory illness in children.
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ItemProtocol for an Economic Evaluation of the Quitlink Randomized Controlled Trial for Accessible Smoking Cessation Support for People With Severe Mental Illness(FRONTIERS MEDIA SA, 2019-09-03)Introduction: Smoking is a major cause of disease burden and reduced quality of life for people with severe mental illness (SMI). It places significant resource pressure on health systems and financial stress on smokers with SMI (SSMI). Telephone-based smoking cessation interventions have been shown to be cost effective in general populations. However, evidence suggests that SSMI are less likely to be referred to quitlines, and little is known about the effectiveness and cost effectiveness of such interventions that specifically target SSMI. The Quitlink randomized controlled trial for accessible smoking cessation support for SSMI aims to bridge this gap. This paper describes the protocol for evaluating the cost effectiveness of Quitlink. Methods: Quitlink will be implemented in the Australian setting, utilizing the existing mental health peer workforce to link SSMI to a tailored quitline service. The effectiveness of Quitlink will be evaluated in a clustered randomized controlled trial. A cost-effectiveness evaluation will be conducted alongside the Quitlink clustered randomized controlled trial (RCT) with incremental cost-effectiveness ratios (ICERs) calculated for the cost (AUD) per successful quit and quality adjusted life year (QALY) gained at 8 months compared with usual care from both health care system and limited societal perspectives. Financial implications for study participants will also be investigated. A modeled cost-effectiveness analysis will also be conducted to estimate future costs and benefits associated with any treatment effect observed during the trial. Results will be extrapolated to estimate the cost effectiveness of rolling out Quitlink nationally. Sensitivity analyses will be undertaken to assess the impact on results from plausible variations in all modeled variables. Discussion: SSMI require additional support to quit. Quitlink utilizes existing peer worker and quitline workforces and tailors quitline support specifically to provide that increased cessation support. Given Quitlink engages these existing skilled workforces, it is hypothesized that, if found to be effective, it will also be found to be both cost effective and scalable. This protocol describes the economic evaluation of Quitlink that will assess these hypotheses. Ethics and dissemination: Full ethics clearances have been received for the methods described below from the University of Newcastle (Australia) Human Research Ethics Committee (H-2018-0192) and St Vincent's Hospital, Melbourne (HREC/18/SVHM/154). The trial has been registered with the Australian and New Zealand Clinical Trials Registry (ACTRN12619000244101). Participant consent is sought both to participate in the study and to have the study data linked to routine health administrative data on publicly subsidized health service and pharmaceutical use, specifically the Medicare Benefits and Pharmaceutical Benefits Schemes (MBS/PBS). Trial findings (including economic evaluation) will be published in peer reviewed journals and presented at international conferences. Collected data and analyses will be made available in accordance with journal policies and study ethics approvals. Results will be presented to relevant government authorities with an interest in cost effectiveness of these types of interventions.