Former Smoker Using the Harmless Cigarette So You Dont Start Smoking Again

Health Psychol Res. 2021; ix(1): 24506.

Touch on of a soft tip nicotine-free harmless cigarette every bit role of a smoking abeyance program with psychological support and varenicline: an integrated workplace smoking abeyance intervention

Marilena Maglia

¹Center of Excellence for the Acceleration of Harm Reduction (COEHAR), Academy of Catania, Italian republic

Pasquale Caponnetto

ⁱⁱCentre of Excellence for the Acceleration of Damage Reduction (COEHAR) and the Section of Educational Sciences, University of Catania, Italy

Riccardo Polosa

^threeCenter of Excellence for the Acceleration of Damage Reduction (COEHAR) and the Department of Clinical and Experimental Medicine, University of Catania, Italy

Cristina Russo

³Heart of Excellence for the Acceleration of Damage Reduction (COEHAR) and the Department of Clinical and Experimental Medicine, Academy of Catania, Italy

Giuseppe Santisi

^ivDepartment of Educational Science, University of Catania, Italy

Received 2021 Jun 1; Accepted 2021 Jun 2.

Abstract

Cigarette consumption in the general population has shown a sustained decline over the past 20 years, but despite this, it is essential to monitor consumption among smokers at their workplace. There is an clan between cigarette addiction and work-related stressors, with high prevalence rates for smokers, at least double those of other adults. This two-group randomized clinical trial compared the 12-week combined effect of psychological support and varenicline associated with the apply or not of a nicotine-free inhaler with a soft mouthpiece (QuitGo™) on the 4 to 24-week cessation rate in enrolled smokers to a smoking cessation program promoted past our research group. The results of the logistic model analysis showed that the likelihood of quitting successfully at calendar week 24 was significantly college in the QuitGO™ group than in the control group for participants with high behavioral dependence equally assessed by Glover-Nilsson Smoking Behavioral Questionnaire-GN-SBQ (OR = 8.55; CI at 95% = 1.75-43.20). The data presented propose that the soft tip nicotine-gratis harmless cigarette may be helpful for smokers and those with piece of work-related stress symptoms who recognize the demand to have a gesture in the traditional cigarette smoking ritual.

Keywords: work-related stress, smoking gesture, working, addiction, smoking abeyance

INTRODUCTION

Although studies on cessation paths for smokers in their workplaces are increasing,1,2 the effects of the group of lifestyle factors (mainly unhealthy diet, lack of physical action, alcohol consumption) with smoking, therefore, demand further research.3

To date, therefore, there is a strong association betwixt smoking and risky lifestyles in the workplace.

These findings are potentially helpful for directing intervention efforts regarding smoking abeyance in professional settings,3 begetting in listen, however, some crucial caveats: the abeyance process itself produces withdrawal symptoms, which include a diverseness of disorders (depressed mood, anxiety, nervousness, restlessness, irritability, fatigue, and sleepiness); these are virtually pronounced in the days immediately following cessation and generally return to baseline levels within 1 month of continued abstinence.4

The treatment of cigarette habit, shorter and more pragmatic than the more durable and complex treatments of other addictions, is based on the essential components of this approach. It consists of an integrated intervention consisting of individual or group assessment, counseling (psycho-behavioral intervention), use of self-help data cloth, and possible pharmacotherapy (essentially nicotine replacement therapy, varenicline, and bupropion), which closely accompanies the individual path and besides supports group treatment, as an integral office or is carried out externally as a parallel and coordinated intervention.5,half-dozen

While the other tools are more than divers and consolidated, the psycho-behavioral intervention component, which will be dealt with more in this article, needs more definition and investigation.

THEORETICAL Background

Many studies report a positive association between smoking and psychological distress, with smoking rates increasing with illness severity linked to stressors.7,8 The association betwixt smoking and stress in the workplace can also be bidirectional: to alleviate the effects of stress, i could outset smoking, but it has been observed that this behavior does non lead to improvements only deterioration.nine Individuals experiencing work-related stress and smokers take more significant nicotine withdrawal symptoms.10,11 Although smokers with loftier levels of stress have similar levels of motivation to quit smoking or even higher than those of smokers in the general population12,13 and they effort to quit with similar rates,xiv the chances of successful forbearance at one calendar month are thirty-50% lower for those with high levels of stress.14

These cursory introductory notes immediately propose that at that place may be a strong clan between cigarette consumption and workplace stress.

Since 1997, the Luxembourg Declaration on Workplace Wellness Promotion in the European union has advocated systematic prevention interventions that involve both the environment and the private.fifteen,16 In practice, however, information technology has been institute that the concrete organizational health direction strategies implemented by companies accept focused on two continuously interacting factors:17

a) the gear up of personal resources made available by workers regarding values, beliefs, attitudes, health practices followed by employees.

b) the set of support, instrumental and psychosocial, that the work organisation makes available to them.

The action of these two factors tends to materialize as a dynamic of continuous commutation:eighteen the more the personal resources (and the efforts produced past the workers) are recognized as counterbalanced and supported past the organization of work, the more the wellness of workers becomes a strategic objective of the arrangement, tending to reduce levels of piece of work stress. This premise is central if we reflect on the fact that almost of the specialist literature on health in the workplace insists on the incidence of health costs borne past organizations every bit a upshot of bad habits of workers and related individual hazard factors (nutrition, obesity, lack of physical activity, drug abuse, booze, and smoking),19 often ignoring the impact of work organization models and related managerial practices.

At this point, a question emerges: what accept managerial practices produced with the strategies to reduce tobacco consumption in the workplace, in the hypothesis that this habit is strictly correlated to work stress?

In 2003, the ILO Safework placed the attitudes and regulatory policies implemented internationally apropos smoke-free workplaces at the centre of attention in its report.20 Too, in the same twelvemonth, Smedslund and colleagues published a meta-belittling report of controlled trials of smoking abeyance practices in the workplace conducted in the 1990s compared to similar studies conducted in the previous decade.21 The meta-assay concluded that the effectiveness of the practical smoking reduction interventions did non extend beyond 12 months, attributing this event to methodological limits of the proposed procedures.

In 2005, a study conducted by Kouvonen and colleagues on 46 thousand workers operating in ten municipalities and 21 Finnish hospitals aimed to verify the correlation between levels of smoking intensity and quality/balance of attempt/advantage promoted by the organisation of piece of work in their smoking impairment prevention policies.22 The report, conducted based on the job strain model and the effort-reward imbalance model approaches,23,24 arrives at the critical conclusion that greater smoking intensity was associated with a more pregnant imbalance between effort-advantage, amongst smokers; in no longer smokers, the aforementioned imbalance raised the likelihood that they would return to smoking. The loftier piece of work tension and the consistent increase in piece of work-related stress, therefore, touch on both the probability of relapse into addiction and increasing smoking intensity, circumstances that lead to emphasizing the importance of the environmental context in the effectiveness of reduction strategies of smoking in the workplace.

That perceived stress in the workplace is an essential factor in increasing-reducing smoking intensity is farther demonstrated by a report conducted in 2016 in 41 countries containing more than 217,000 participants.25 Research conducted in Nippon in the same period confirmed that smoking reduction policies in the workplace are positively correlated with a full general reduction in public health expenses and burdens and increased company productivity and organizational performance.26

In conclusion, information technology is well established that developed smoking rates have remained relatively stable in recent years.27 Unfortunately, around lxxx% of smokers do not immediately quit.28,29 Agile abeyance induction interventions that promote smoking cessation efforts amongst unmotivated smokers could profoundly impact public wellness even if efficacy is low.

Stress is positively associated with continued smoking and negatively associated with quitting.30 Predictably, smokers who reported higher levels of negative mood and stress-related symptoms were less probable to quit than smokers with fewer stress-related disorders.9

Every bit previously advocated, nonetheless, corporate smoking reduction practices within the workplace must necessarily consider 3 aspects contributing to structuring a wide-ranging strategy. The methods aimed at reducing smoking intensity must exist conceived within an organizational culture31 structured based on two major pillars: a climate of health and safety in which the efforts required of the workers with insured rewards; a recognition of the value and importance of personal resources such every bit self-efficacy, resilience, quality, and density of social support, elements that act as "mediators" between health promotion practices and piece of work organization tools.

METHODS

Regular smokers of traditional cigarettes (≥10 cigarettes/twenty-four hours, for at to the lowest degree 1yrs) treated at their workplace (a medicine manufacturing plant in Catania) were involved in the study. Participants with an exhaled breath carbon monoxide concentration (eCO) of ≥10 ppm were considered eligible for participation.

This written report included a 2-grouping randomized clinical trial to compare the effect of a nicotine-gratis inhaler with a soft mouthpiece (QuitGo™) on quit rates at 4 and 24 weeks in smokers enrolled in a smoking cessation programme; smokers were randomized to receive or not a soft tip inhaler (Figure one).

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Pharmacologic therapies were prescribed over 12 weeks co-ordinate to manufacturer guidelines. Participants were prescribed varenicline at 1mg twice daily. Psychological back up was delivered at each visit.

At the starting time visit, social and demographic factors and accurate smoking history were annotated. Scoring of the self-evaluation of depression was assessed by the Brook Depression Inventory (BDI).32 Concrete dependence and behavioral cigarette dependence were measured by Fagerström Test for Cigarette Dependence (FTCD)33 and Glover-Nilsson Smoking Behavioral Questionnaire (GN-SBQ),34 respectively.

Participants were advised to quit smoking and were asked to set a quit appointment inside the next seven days. Smokers were prescribed varenicline 2 mg/day for 12 weeks, and they were assigned to either an active or a command group. Smokers of the active group received a free supply of a soft tip nicotine-complimentary (mint olfactory property) QuitGO™ and instructed nearly its usage. Smokers were then invited to volume their follow-up appointment within one week from the quit date. Over the weeks, support has been offered for smoking participants, characterized past psychological support and telephone contacts through WhatsApp to encourage participants' motivation. The levels of eCO were carried out at each visit with the office of checking the objective smoking abstinence.

During the follow-ups of weeks 4 and 24, the participants were followed by an contained researcher. This choice was fabricated to avoid possible contagion with respect to the noesis of the study participants' basic characteristics and group allocation.

Subjects who reported quitting smoking and had eCO <10 levels were referred to every bit quitters. Those who did non see these criteria were considered to be failures or relapsers.

Standing smokers and relapsers were put in a smoking reference grouping to compare the report measures after smoking cessation between groups. Success rates were divers as 24-calendar week success charge per unit - 24WSR (calculated as the ratio between a number of eCO-verified 24-calendar week quitters over the number of smokers setting a quit date) and the four-week success rate - 4WSR (calculated as the ratio betwixt the number of eCO-verified four-calendar week quitters over the number of smokers setting a quit date).35,36

The sample size calculation for this written report, based on the expected cessation rates from a previous smoking cessation written report,37 indicates that 63 subjects are required to take 80% power with a ii-sided 0.05 significance level test to detect a difference of at least 10% quit rate between report groups. Allowing for a conservative attrition rate of xl% at our institution, the target number of participants was increased to a total of 120.

In the primary analyses, 4WSR and 24WSR were computed by excluding the proportion of subjects lost to follow-upward (per-protocol analysis). As secondary analyses and for comparison purposes, 4WSR and 24WSR were besides calculated by including all enrolled participants - assuming that all those individuals who will exist lost to follow-up are classified as smoking cessation failures (intention-to-care for analysis). One-fashion assay of variance (ANOVA) was used to test between-group differences for normally distributed variables, and Mann-Whitney U-test was used for nonparametric variables. χ2 statistics were used to calculate the significance of observed differences in distribution at four and 24 calendar week quit rates. A logistic regression model was used to assess the relative risk of touch base QuitGO™ apply in influencing the quit rate at 4 and 24 weeks: Odds ratios (OR) and 95% confidence intervals (CI) were calculated and adjusted for the following confounders: gender, age, FTCD, N. of pack/yrs, instruction level, cigarettes/day smoked at enrolment. Continuous variables were dichotomized using the following cutting-off levels: age 45.5 yrs (range 23-69), FTCD half-dozen; No. of pack/year 48 (highest quartile of its distribution); education level 13 yrs; cigarettes/day at enrolment ten. A p level<0.05 was considered statistically significant. The statistical analysis was conducted past an independent biostatistician who was unaware of the group allocation of the study participants.

The study complied with the ethical principles of the Declaration of Helsinki. All participants provided written informed consent. The study was conducted in understanding with the ethical norms set by the Italian National Psychological Association. A accomplice of workers carried out this study within the framework of occupational wellness surveillance following the Italian Law (no. 81/2008).

RESULTS

120 smokers of traditional cigarettes who experience work-related stress assessed by the Karasek Job Content Questionnaire (JCQ) were enrolled in the study (Table 1). No significant difference was found between report groups for all the variables under investigation at the first visit. Threescore-nine subjects had a low caste of behavioral cigarette dependence (GN-SBQ ≤22), and 51 presented a high level (GN-SBQ >22). At four-week, 12/60 participants (20%) were lost at follow-up in QuitGO™ grouping and 16/lx (26.6%) in control grouping (p=0.366, χ2). A 24-week, smokers who were lost at follow-upwards deemed for 15/60 (25%) in the QuitGO™ grouping and eighteen/60 (xxx%) in the reference group (p=0.501, χ2). Later on, out of 120 participants, 92 (76.half dozen%) and 87 participants (72.5%) completed the four-week and 24-week visits, respectively.

Tabular array one. Smokers' characteristics at baseline.

	QuitGO^™ group	Reference group	p-value
Gender (Thousand/F, No.)	39/21	40/20	-^†
Age (yrs, mean±SD)	46.ane±x.vii	46.7±9.four	0.123^#
Smokeyears (mean±SD)	28.9±11.seven	29.iii±7.9	0.151^#
Cigarette/mean solar day at enrolment (No., median and IQ)	26.3 (20.0-30.0)	24.five (eighteen.0-30.0)	0.295^§
No. of pack/yr (median and IQ)	37.eight (25.five-48.7)	34.three (25.i-47.5)	0.367^§
Exhaled CO (ppb, mean±SD)	xxx.iv±15.8	28.3±12.iv	0.234^#
Age at initiation (yrs, mean±SD)	17.4±5	16±5	0.626^#
BDI (hateful±SD)	22.8±four.iii	22.5±3	0.677^#
FTCD (median and IQ)	7.0 (six.0-viii.0)	6.5 (4.5-7.0)	0.051^§
GN-SBQ (median and IQ)	20.0 (15.0-33.0)	20.0 (15.0-32.0)	0.848^§

†χ2test; ^#i-fashion ANOVA; §Mann-Whitney U-test

Continuous variables are presented every bit means ± standard deviations (SD) for normally distributed variables or as medians and interquartile ranges (IQ) for nonparametric variables.

Quit rates at 4-week and 24-week are shown in Table 2. For the whole sample, no significant deviation was found in quit rates between the QuitGO™ group and the reference group at any fourth dimension. Even so, when smokers were separately evaluated based on their GN-SBQ score at baseline, a significant deviation was found in the frequency distribution of smoking abeyance quit rates: in smokers with loftier GN-SBQ (i.e., people with essentially high strong psycho-behavioral dependence), the quit rate in the QuitGO™ group was significantly higher than in the control group. The results of the logistic model analysis showed that the probability of successful quitting at week 24 was significantly higher in the QuitGO™ grouping than in the control group for participants with high GN-SBQ scores (OR = 8.55; 95%CI = one.75-43.20).

Table 2. Smoking cessation quit rates at week-4 and week-24.

	No QuitGO™		QuitGO™
Per-protocol analysis (No., %)	week-4	week-24	week-4	week-24	p-value week-iv	p-value week-24
Overall sample	22/44 (l%)	17/42 (41.5%)	24/48 (50%)	xx/45 (45.5%)	0.991	0.701
Low GN-SBQ (≤22)	13/24 (54.one%)	12/22 (54.v%)	viii/28 (28.5%)	iv/26 (fifteen.iii%)	0.056	0.002
High GN-SBQ (>22)	9/twenty (45.9%)	5/20 (25.0%)	sixteen/20 (81.five%)	16/19 (84.2%)	0.021	0.0001
Intention-to-treat analysis (No., %)
Overall sample	22/60 (36.six%)	17/60 (28.3%)	24/lx (forty%)	20/threescore (33.3%)	0.703	0.503
Depression GN-SBQ (≤22)	13/34 (38.2%)	12/34 (35.2%)	8/35 (22.8%)	4/35 (eleven.4%)	0.133	0.016
High GN-SBQ (>22)	ix/26 (34.6%)	five/26 (19.2%)	16/25 (64%)	16/25 (64%)	0.019	0.001

The majority of smokers in the QuitGO™ group were satisfied with using this tool, principally for its anti-stress activeness. About 80% of participants declared that placing the QuitGO™ in their oral cavity was useful to distract them from cigarettes craving.

Discussion

This is the starting time written report to investigate the effect of adding a soft tip nicotine-free harmless cigarette equally part of a psychologically supported and varenicline quit workplace smoking program in smokers with work-related stress symptoms. No pregnant difference in smoking cessation rates was observed betwixt smokers using the device and the reference grouping for the overall sample. This study fabricated information technology possible to discover some positive effects related to the employ of the investigated products, considered to be at nothing risks, which significantly reduces tobacco dependence, especially for those related to behavioral aspects.

The results of the logistic model assay showed that the likelihood of successfully quitting at week 24 was significantly higher in the QuitGO™ group than in the command group for participants with high GN-SBQ scores. The information presented propose that QuitGO™ may exist helpful for those smokers, such equally those with work-related stress symptoms, who recognize the demand to have a gesture in the traditional cigarette smoking ritual, especially in contexts where smoking is impossible because it is prohibited, equally the workplace.

The literature confirms the results of another report.35 Other inhalers allowed the smokers to cope with the demand to recoup for "peckish" used in a traditional cigarette smoking cessation programme.

The novelty of this study, conducted at a workplace, compared to the previous ones, focuses its attention on a sample of participants who take symptoms of work-related stress that typically have a higher per centum of smoking relapse, which is made up of scarce internal resource, understood equally problem-solving skills, social skills and other types of skills related to the ability to manage frustration or other emotions.38

CONCLUSIONS

An of import fact that emerged from this research is that smokers who have used QuitGO™ were satisfied with its product. It allows the smoker to avert the constant need to respect the typical gestures of those who fume traditional cigarettes. These data will enable u.s. to understand how important information technology is for a smoker to appreciate the demand for gestures without necessarily having the satisfaction given past nicotine.39 A proposition for hereafter studies volition be to broaden the study sample by observing multiple workplaces and dissimilar professional figures.

Conflicts of Interest

RP has received lecture fees and research funding from Pfizer, Inc., GlaxoSmithKline plc, CV Therapeutics, NeuroSearch A/South, Sandoz, MSD, Boehringer Ingelheim, Novartis, Duska Therapeutics, and Forest Laboratories. He has also served equally a consultant for Pfizer, Inc., Global Wellness Brotherhood for treatment of tobacco dependence, CV Therapeutics, NeuroSearch A/S, Boehringer Ingelheim, Duska Therapeutics, Forest Laboratories, ECITA (Electronic Cigarette Manufacture Trade Association, in the United Kingdom), Health Diplomat (consulting company that delivers solutions to global health problems with special emphasis on harm minimization), and Pharmacielo. RP was awarded an Investigator-Initiated Study accolade program established by Philip Morris International in 2017, merely subsequently resigned from the function of Primary Investigator in 2018, earlier the trial began. Lecture fees from a number of European EC industry and trade associations (including Fédération Interprofessionnelle de la VAPE in French republic and Federazione Italiana Esercenti Svapo Elettronico in Italy) were directly donated to vaper advocacy no-profit organizations. RP is the Founder of the Center of Excellence for the acceleration of Harm Reduction at the University of Catania (CoEHAR), which has received a grant from Foundation for a Fume Free Globe to develop and carry out eight enquiry projects. RP is also currently involved in the following pro bono activities: scientific counselor for LIAF, Lega Italiana Anti Fumo (Italian acronym for Italian Anti Smoking League) and Chair of the European Technical Committee for standardization on Requirements and test methods for emissions of electronic cigarettes (CEN/TC 437; WG4). PC is paid by the University of Catania as an external part-time researcher and adjunct professor of clinical, addiction, and general psychology. He has been affiliated to the CoEHAR since Dec 2019 in a pro bono role. He is coauthor of a protocol newspaper supported by an Investigator-Initiated Study laurels program established by Philip Morris International in 2017. The other authors have no conflict of interests to declare.

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Source: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8567756/