Dataset Information

The Moment Study: protocol for a mixed method observational cohort study of the Alternative Nicotine Delivery Systems (ANDS) initiation process among adult cigarette smokers.

ABSTRACT: INTRODUCTION:Alternative Nicotine Delivery Systems (ANDS) such as e-cigarettes are battery-powered devices that aerosolize nicotine and other substances to simulate smoking without using tobacco. Little is known about the ANDS initiation process among adult smokers. The aims of this research are threefold to: (1) examine how ANDS use affects cigarette use; (2) examine how the immediate environmental and psychosocial contexts of cigarette and ANDS use vary within-and between-participants in general and by menthol preference and race; and, (3) examine participants' 'lived experience' of the subjective perceptions, meaning, influences and utility of cigarette and ANDS use. METHODS AND ANALYSES:This study's mixed method, 6-week longitudinal design will produce a detailed description of the ANDS initiation process among adult smokers (N=100). Qualitative and quantitative data collection will include 3?weeks of: (1) ecological momentary assessment of patterns of cigarette/ANDS use, satisfaction, mood and craving; (2) geospatial assessment of participants' environment, including indoor and outdoor cigarette/ANDS norms and rules; (3) in-depth interviews about the meaning and utility of cigarette smoking and ANDS use; and, (4) saliva cotinine and exhaled carbon monoxide (CO) biomarkers. A diverse sample will be recruited with an equal number of menthol and non-menthol cigarette smokers. As the primary independent variable, we will investigate how ANDS use affects cigarette consumption. We will also examine how smoking-related and ANDS-related rules and norms surrounding product use influence cigarette and ANDS product use, and how the subjective effects of ANDS use affect ANDS perceptions, beliefs and use. ETHICS AND DISSEMINATION:This study was funded by the National Institute on Drug Abuse of the US National Institutes of Health (1R21DA036472), registered at ClinicalTrials.gov (NCT02261363), and approved by the Chesapeake IRB (Pro00008526). Findings will be disseminated to the scientific and lay community through presentations, reports and scientific publications. TRIAL REGISTRATION NUMBER:NCT02261363; Pre-results.

SUBMITTER: Pearson JL

PROVIDER: S-EPMC4854005 | biostudies-literature | 2016 Apr

REPOSITORIES: biostudies-literature

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Publications

The Moment Study: protocol for a mixed method observational cohort study of the Alternative Nicotine Delivery Systems (ANDS) initiation process among adult cigarette smokers.

Pearson Jennifer L JL Smiley Sabrina L SL Rubin Leslie F LF Anesetti-Rothermel Andrew A Elmasry Hoda H Davis Megan M DeAtley Teresa T Harvey Emily E Kirchner Thomas T Abrams David B DB

BMJ open 20160422 4

<h4>Introduction</h4>Alternative Nicotine Delivery Systems (ANDS) such as e-cigarettes are battery-powered devices that aerosolize nicotine and other substances to simulate smoking without using tobacco. Little is known about the ANDS initiation process among adult smokers. The aims of this research are threefold to: (1) examine how ANDS use affects cigarette use; (2) examine how the immediate environmental and psychosocial contexts of cigarette and ANDS use vary within-and between-participants ...[more]

PMID: 27105716

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Project description:A few studies have assessed the short-term effects of low-dose nicotine e-cigarettes, while data about nicotine-free e-cigarettes (NF e-cigarettes) are scanty. Concerns have been expressed about the use of NF e-cigarettes, because of the high concentrations of propylene glycol and other compounds in the e-cigarette vapor.This laboratory-based study was aimed to compare the effects of ad libitum use of a NF e-cigarette or and a traditional cigarette for 5 min in healthy adult smokers (n = 10) and non-smokers (n = 10). The main outcome measures were pulmonary function tests, fraction of exhaled nitric oxide (FeNO) and fractional concentration of carbon monoxide (FeCO) in exhaled breath.The traditional cigarette induced statistically significant increases in FeCO in both smokers and non-smokers, while no significant changes were observed in FeNO. In non-smokers, the traditional cigarette induced a significant decrease from baseline in FEF75 (81 % ± 35 % vs 70.2 % ± 28.2 %, P = 0.013), while in smokers significant decreases were observed in FEF25 (101.3 % ± 16.4 % vs 93.5 % ± 31.7 %, P = 0.037), FEV1 (102.2 % ± 9.5 % vs 98.3 % ± 10 %, P = 0.037) and PEF (109.5 % ± 14.6 % vs 99.2 % ± 17.5 %, P = 0.009). In contrast, the only statistically significant effects induced by the NF e-cigarette in smokers were reductions in FEV1 (102.2 % ± 9.5 % vs 99.5 ± 7.6 %, P = 0.041) and FEF25 (103.4 % ± 16.4 % vs 94.2 % ± 16.2 %, P =? .014).The present study demonstrated that the specific brand of NF e-cigarette utilized did not induce any majoracute effects. In contrast, several studies have shown that both traditional cigarettes and nicotine-containing e-cigarettes have acute effects on lung function. Our study expands on previous observations on the effects of NF e-cigarettes, but also for the first time describes the changes induced by smoking one traditional cigarette in a group of never smokers.The short-term use of the specific brand of NF e-cigarette assessed in this study had no immediate adverse effects on non-smokers and only small effects on FEV1 and FEF25 in smokers. The long-term health effects of NF e-cigarette use are unknown but worthy of further investigations.Clinicaltrials.gov: NCT02102191.

Project description:BackgroundThe potential of electronic nicotine delivery systems (ENDS) to reduce the cardiovascular and other disease risks of smoking is of great interest. While many smokers report using ENDS for cessation, their impact under real-world use patterns and conditions on adult smokers' quitting behavior is uncertain. The objective of this study was to generate more recent and comprehensive evidence on the effect of "real world" ENDS use on the population quit rates of adult smokers while taking account of frequency and duration of use, device type, e-liquid flavor, and reasons for use.Methods and findingsWe conducted a population-based, prospective cohort study of a random probability sample of 1284 U.S. adult smokers recruited in August/September 2015 and re-contacted one-year later (September 2016) from GfK's KnowledgePanel, a national, probability-based web-panel designed to be representative of non-institutionalized U.S. adults. Among the 1081 baseline smokers who remained members of KnowledgePanel, 858 completed the follow-up survey. The primary outcome was smoking abstinence for at least 30 days prior to follow-up. Secondary outcomes were making a quit attempt during the 12-month study period and number of cigarettes smoked per day at follow-up. The adjusted odds of quitting smoking were lower for those that used ENDS at baseline (9.4%, 95% CI = 5.22%-16.38%; AOR = 0.30, 95% CI = 0.13-0.72) compared to smokers who did not use at ENDS (18.9%, 95% CI = 14.24%-24.68%). Smokers who used ENDS daily at some point during the study period were also less likely to quit smoking than nonusers (AOR = 0.17; 95% CI = 0.04-0.82). Limited ability to draw causal inferences from the observational design and a lack of biochemical verification of quitting smoking or ENDS use are limitations of this study.ConclusionsWe found no evidence that ENDS use, within context of the 2015-2016 US regulatory and tobacco/vaping market landscape, helped adult smokers quit at rates higher than smokers who did not use these products. Absent any meaningful changes, ENDS use among adult smokers is unlikely to be a sufficient solution to obtaining a meaningful increase in population quit rates. Additional research is needed to reconcile the divergent literature and monitor the impact of ENDS in an environment of rapidly evolving markets and regulatory policies.

Project description:Stress is known to influence smoking relapse. Experimental studies indicate that acute stress increases nicotine-seeking behavior, yet neurobiological mechanisms remain poorly understood. Herein, we investigated disrupted excitatory neural activity in the dorsolateral prefrontal cortex (dlPFC) as a mechanism of stress-induced nicotine-seeking behavior. Non-treatment-seeking cigarette smokers were screened for psychiatric, medical, and neuroimaging contraindications. Using a double-blind, placebo-controlled, randomized crossover design, participants (N = 21) completed two oral-dosing sessions: stress (yohimbine 54 mg + hydrocortisone 10 mg) vs placebo (lactose 54 mg + lactose 10 mg). During each experimental session, working memory proficiency, dlPFC excitatory neural activity, nicotine-seeking behavior, and subjective effects were measured. dlPFC excitatory neural activity was quantified via glutamate modulation during working memory performance using functional proton magnetic resonance spectroscopy. Nicotine-seeking behavior was assayed using a cigarette puffs vs money choice progressive ratio task. Results indicated that yohimbine + hydrocortisone evoked a sustained physiological stress response (elevated heart rate, blood pressure, saliva cortisol, and saliva α-amylase levels; ps < .05). Relative to placebo levels, acute stress increased nicotine-seeking behavior (ps < .05), disrupted dlPFC glutamate modulation (p = .025), and impaired dlPFC function (working memory proficiency; ps < .05). The stress-induced increase in nicotine-seeking behavior was linearly related to the stress-induced disruption of dlPFC glutamate modulation (R2 = 0.24-0.37; ps < .05). These findings suggest that disrupted dlPFC excitatory neural activity is a neurobiological correlate of acute stress-induced nicotine-seeking behavior. These findings further emphasize the central role of the dlPFC in regulating drug-seeking behavior. Future studies are needed to evaluate interventions to improve dlPFC resilience to acute stress effects, including neurostimulation, working memory training, and "anti-stress" medications.

Project description:Nicotine dependence and smoking quantity are both robustly associated with the CHRNA5-A3-B4 gene cluster in the 15q25 region, and SNP rs16969968 in particular. The purpose of this paper is to use structural equation modeling techniques (SEM) to disentangle the complex pattern of relationships between rs16969968, nicotine quantity (as measured by the number of cigarettes an individual smokes per day; CPD) and nicotine dependence (as measured by the Fagerström Test for Nicotine Dependence; FTND). CPD is an indicator, but also a potential cause, of FTND, complicating the interpretation of associations between these constructs and requires a more detailed investigation than standard GWAS or general linear regression models can provide. FTND items and genotypes were collected in four samples, with a combined sample size of 5,373 respondents. A mega-analysis was conducted using a multiple group SEM approach to test competing hypotheses regarding the relationships between the SNP rs16969968, FTND and CPD. In the best fitting model, the FTND items loaded onto two correlated factors. The first, labeled "maintenance," assesses the motivation to maintain constant levels of nicotine through out the day. The second was labeled "urgency" as its items concern the urgency to restore nicotine levels after abstinence. We focus our attention on the "maintenance" factor, of which CPD was an indicator. The best fitting model included a negative feedback loop between the Maintenance factor and CPD. Accordingly, the motivation to maintain higher levels of nicotine increased the quantity of nicotine consumed, which subsequently decreases the maintenance motivation. The fact that the Maintenance-CPD feedback model fits the data best implies that there are at least two biological pathways that lead from rs16969968 to smoking behaviors. The model is consistent with a supply and demand system, which allows individuals to achieve a homeostatic equilibrium for their nicotine concentration.

Dataset Information

The Moment Study: protocol for a mixed method observational cohort study of the Alternative Nicotine Delivery Systems (ANDS) initiation process among adult cigarette smokers.

Publications

The Moment Study: protocol for a mixed method observational cohort study of the Alternative Nicotine Delivery Systems (ANDS) initiation process among adult cigarette smokers.

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