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 Table of Contents  
ORIGINAL ARTICLE
Year : 2019  |  Volume : 3  |  Issue : 2  |  Page : 105-109

Effectiveness of smoking cessation program using nicotine chewing gums and transdermal nicotine patches among patients with schizophrenia in Chennai City: An interventional study


1 Department of Public Health Dentistry, Ragas Dental College, Chennai, Tamil Nadu, India
2 Department of Public Health Dentistry, Saveetha Dental College and University, Chennai, Tamil Nadu, India

Date of Submission05-Feb-2019
Date of Decision27-Mar-2019
Date of Acceptance29-Mar-2019
Date of Web Publication18-Dec-2019

Correspondence Address:
Dr. R Dharshanram
Department of Public Health Dentistry, Ragas Dental College, 2/102, SH49, Uthandi, Chennai - 600 119, Tamil Nadu
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/aip.aip_5_19

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  Abstract 


Background: Schizophrenia (SCH) is a common illness with lifetime risk of approximately one in 100 people. The most likely age of onset for men is the mid–20s, while for women, it is in the early 30s. Schizophrenic patients have higher rates of nicotine dependence. This study aims to compare the effectiveness of smoking cessation program using nicotine chewing gums and transdermal nicotine patches (TNPs) among schizophrenic patients in Chennai city. Methods: Participants were required to have a diagnosis of SCH in maintenance stage, who met diagnostic and statistical manual mental disorder-IV for SCH, to be at least 18 years old. The study participants were divided into two groups: Group A (10 participants) and Group B (10 participants). Nicotine chewing gums were administered to Group A participants, and TNPs were administered to Group B participants. Results: Among 20 participants, all the study participants were male with a mean age of 45.20 years. In this study, significant reduction on carbon monoxide level (mean difference – 3.2 ± 0.78) and number of cigarettes (mean difference – 4.11 ± 0.55) were noted on TNP trial (P < 0.64), and the significant difference on nicotine dependence was seen between groups (Group A and Group B) (P = 0.00). Conclusion: Even though the results of our study showed reduction in smoking, but not smoking cessation, still, a better understanding of the factors that lead to successful smoking cessation outcomes in smokers with SCH and other psychiatric disorders may lead to improvement in treatment plan.

Keywords: Nicotine dependence, nicotine gums, schizophrenia, transdermal nicotine patch


How to cite this article:
Dharshanram R, Iyer K, Arthi B, Madankumar P D. Effectiveness of smoking cessation program using nicotine chewing gums and transdermal nicotine patches among patients with schizophrenia in Chennai City: An interventional study. Ann Indian Psychiatry 2019;3:105-9

How to cite this URL:
Dharshanram R, Iyer K, Arthi B, Madankumar P D. Effectiveness of smoking cessation program using nicotine chewing gums and transdermal nicotine patches among patients with schizophrenia in Chennai City: An interventional study. Ann Indian Psychiatry [serial online] 2019 [cited 2020 Apr 9];3:105-9. Available from: http://www.anip.co.in/text.asp?2019/3/2/105/262204




  Introduction Top


Schizophrenia (SCH) is a common illness with lifetime risk of approximately one in 100 people.[1] The most likely age of onset for men is the mid-20s, while for women, it is in the early 30s.[2] Patients with SCH have higher rates of nicotine dependence through cigarette smoking (58%–88%), compared to the general population (about 25%),[3] and are often heavily dependent smokers who have great difficulty with smoking cessation. A number of potential interventions could improve outcomes for smoking cessation/reduction in patients with SCH. As individuals with SCH are at high risk for developing medical morbidity and mortality related to chronic smoking, helping patients with SCH to quit smoking is an important undertaking.[4],[5],[6]

Nicotine gum has been shown to aid withdrawal and double success rates of smoking cessation. The use of nicotine polacrilex increases success rates within the range of 15%–30% in smoking cessation. In physician settings, the added benefits may be less; but nonetheless, the success rate can double [7] or patient use it wrongly. In most instances, patients do not use enough pieces of gum per day to relieve withdrawal and urge to smoke, or they stop the usage soon.[8]

Transdermal nicotine patches (TNPs) are used to help people stop smoking cigarettes and provide a source of nicotine that reduces the withdrawal symptoms experienced when smoking is stopped. Patch has several advantages: it delivers a steady supply of nicotine through the skin and into bloodstream for 18–24 h and does not give users the buzz they may feel from gums and lozenges. Further, it is the easiest form to stop using when the cessation program is completed.[9]

The relationship between smoking and major depressive disorder has been more extensively studied and has important implications for success in smoking cessation [10] such that a history of major depressive disorder has been recognized as a poor prognostic sign for success in smoking cessation.

Few smoking cessation programs have been targeted toward psychiatric patients, particularly those with schizophrenic disorders. Addington et al. reported the use of a modified version of the 7-week behavioral program offered by the American Lung Association Freedom from smoking program.[11] This group therapy program emphasized psychoeducation, positive reinforcement, anxiety reduction, and adjunctive use of the nicotine transdermal patch; the endpoint smoking abstinence rate in Addington et al.'s study was 42%.[11],[12] Behavioral interventions such as contingency management may also improve smoking cessation outcomes in opiate-dependent smokers [13],[14] and in smokers with SCH.[15] Preliminary has suggested that only smoking cessation intervention (e.g., motivational enhancement therapy and relapse prevention therapy) may improve treatment outcomes and tolerability of treatment.

In the study reported here, our aim was to compare the effectiveness of smoking cessation program using nicotine chewing gums and TNPs among patients with SCH in Chennai city.


  Methods Top


Participants were required to have a diagnosis of SCH, based on the structured clinical interview by diagnostic and statistical manual mental disorder-IV (DSM-IV), to be at least 18 years old and who were on medication (bupropion – atypical antidepressant), to have smoked 5–15 cigarettes/day for at least the past year, to have the score of at least 6 on the Fagerstrom test for nicotine dependence (FTND), indicating high level of dependence,[16] and to indicate an interest in quitting smoking someday. Exclusion criteria included medical conditions (diabetes, hypertension, and psychological disorder other than SCH) contraindicating transdermal nicotine use, severe levels of disorientation of uncooperativeness, smokeless tobacco users, alcohol users under any cessation treatment, or positive breath alcohol level at any session. Procedures were approved by the Institutional Review Board of Ragas Dental College and Hospital, and written informed consent was obtained from all participants. [Figure 1] and [Figure 2] represents the procedure performed in the study.
Figure 1: Breath analyzer to check carbon monoxide level

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Figure 2: Transdermal nicotine patch placement

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Baseline characteristics

Individual measures collected on the 1st day of interventional program included demographic characteristic, smoking history (number of cigarettes per day),[17] and a 10-point scale that measures the motivation to quit smoking in Motivation to Stop Smoking scale. The current psychiatric symptom levels were measured using clinical global impression-SCH (CGI-SCH) scale.[18]

Expired breath carbon monoxide (CO) was measured in ppm from a single breath using a CO monitor.

Procedure

Twenty male outpatients with diagnosis of SCH were recruited from a local outpatient SCH research foundation. Psychiatric diagnosis was confirmed by a board-certified psychiatrist. We adopted an international standard for diagnosed smokers using nicotine replacement therapy (NRT) in which 14 mg of nicotine patches were delivered in 24 h and 4 mg of nicotine chewing gums thrice a day were administered for 1 week. The study participants were divided into two groups: Group A (10 participants) and Group B (10 participants) [Flowchart 1]. Nicotine chewing gums were administered to Group A participants, and TNPs were administered to Group B participants. For nicotine chewing gums, participants were advised to taste the nicotine or feel a slight tingling in mouth and then stop chewing and place (park) the chewing gum between cheek and gum. When the tingling was almost gone (about 1 min), to start chewing again and repeat this procedure for about 30 min. Nicotine patch consisted of a thin and flexible paper medium sandwiched between clear double-sided tape (against the skin) and a flesh color bandage (on the outside). Only research staff applied and removed the patches. Participants were asked to look away while the patch was applied because some of the participants could feel the sense of patch applied, and the entire area was marked with permanent marker around the patch and arm.



Participants were instructed not to remove this patch unless they were experiencing unacceptable levels of side effects (e.g. dizziness, rashes, and dermatitis) from the patches. Participants were further instructed to notify the research staff before removing the patches and that removing the patches would necessitate their being withdrawn from the study.

Smoking abstinence was determined by self-reported cigarette use and verified with a CO level. Antipsychotic medications were maintained at the prestudy dose for the duration of the study; individuals who required a dose change for symptom stabilization or antipsychotic side effects were excluded from the analysis.

Smoking cessation was strongly encouraged; however, education of specific motivational techniques was not included in these sessions. Effectiveness of nicotine chewing gums and TNPs in smoking cessation was considered the outcome measure, i.e., 7-day point prevalence abstinence defined as self-reported reduction in number of cigarettes in the preceding 7 days plus an expired CO level of <5 ppm.

Statistical analysis

All analyses were conducted with International Business Machines (IBM), SPSS version 19 (Tamil Nadu, India) and the significance levels were all set at P = 0.05 (two-tailed). At first, the representativeness of the individuals entered into the analyses was tested. Correlation between subjective and objective smoking dependency among patients with SCH was measured using Spearman's rho test. Comparison of subjective and objective smoking dependency with the group was measured using Wilcoxon signed-rank test. Comparison of smoking dependency between Group A and Group B was measured using Mann–Whitney U-test. Potential confounders such as age, sex, extent of neuroleptic-induced extrapyramidal symptoms severe acute respiratory syndrome (SARS), severity of negative symptoms, and antipsychotic dose related to smoking were controlled. Chi-square test was computed to test the difference between groups (Group A and Group B).


  Results Top


All individuals met criteria for a DSM-IV diagnosis for SCH. Individuals smoked an average of about 5–15 (7.77 ± 1.07) cigarettes per day, had a mean baseline expired breath CO level of 7.95 ± 1.23 ppm, CGI-SCH scale score of 4.00 ± 1.21, and a mean FTND score of approximately 4.80 ± 1.57, indicating moderate levels of nicotine dependence. Among 20 participants, all the study participants were male with a mean age of 45.20 ± 11.03 years.

In this study, significant reduction on CO level (mean difference – 3.2 ± 0.78) and number of cigarettes (mean difference – 4.11 ± 0.55) were noted on TNP trial (P < 0.64), and the difference between groups (Group A and Group B) was significant (P = 0.00) [Table 1], [Table 2], [Table 3]. Accordingly, our findings suggest that TNPs may be a clinically useful treatment for tobacco dependence in smokers with SCH and appear to be safe and well tolerated.
Table 1: Correlation between subjective and objective smoking dependency among patients with schizophrenia

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Table 2: Comparison of subjective and objective smoking dependency within the group

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Table 3: Comparison of smoking dependency between the groups

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  Discussion Top


The major finding of this study was that schizophrenic individuals who were treated with TNPs had enhanced smoking reduction rates. Although relapse rates are considerably high in the general population after short-term discontinuation in smoking cessation treatment, the nicotinic receptor expression does not return to normal after smoking cessation in smokers without SCH. In SCH, nicotinic activity is abnormally low at baseline, which is increased by smoking or NRT, and is not expected to return to a normal baseline after smoking cessation.

At least, three studies have found that the atypical antipsychotic drug – clozapine may reduce smoking consumption in schizophrenic smokers. Our data on individuals grouped by nicotine transdermal patch suggest a differential effect for improving smoking abstinence rates in schizophrenic patients.[19],[20],[21]

A study by Freedman et al. among patients who were receiving atypical antidepressant medications (bupropion 150 mg) treated with TNP was well tolerated and superior to antipsychotic medications with nicotine chewing gums.

However, it should be noted that given the low abstinence rates for nicotine chewing gums alone on short-term outcomes, the efficacy of the nicotine chewing gums employed in this study appears to be minimal, suggesting that the TNPs were an effective intervention.

Side effects of the combination were generally modest and included poor concentration, lightheadedness, muscle stiffness, activation, and insomnia. The increase in muscle stiffness may be well related to elevation of antipsychotic drug levels through deinduction of CYP 1A2 by smoking cessation [22] or inhibition of CYP2D6 by bupropion.

Finally, it should also be remembered that this study was conducted in stable outpatients. Acutely ill inpatients may respond differently to smoking abstinence and treated or untreated nicotine withdrawal, and generalizations of our findings to an acutely ill inpatient population should not be made.

This study failed to draw meaningful inferences on abstinence because no one had stopped smoking, but only smoking reduction was seen among the population.


  Conclusion Top


Although results of our study showed smoking reduction not a smoking cessation, still, a better understanding of the factors that lead to successful smoking cessation outcomes in smokers with SCH and other psychiatric disorders may lead to improved treatment for this subset of smokers, whose smoking habits are among the most refractory to conventional smoking cessation interventions. Hence, selection of the right intervention is the most important in the field of smoking cessation.

Ethical statement

This study was approved by Institutional Ethics Committee with reference number RDC-123 obtained on 28th May 2018.

Declaration of Patient Consent

Patient consent statement was taken from each patient as per institutional ethics committee approval along with consent taken for participation in the study and publication of the scientific results / clinical information /image without revealing their identity, name or initials. The patient is aware that though confidentiality would be maintained anonymity cannot be guaranteed.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
  References Top

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2.
National Alliance of Mental Illness. Available from: https://www.nami.org/Learn-More/Mental-Health-Conditions/Schizophrenia. [Last accessed on 2019 Mar 05].  Back to cited text no. 2
    
3.
Consensus Statement on Evaluation of Outcomes for Pharmacotherapy for Substance Abuse/Dependence. Washington, DC: National Institute on Drug Abuse/College on Problems of Drug Dependence; April, 1999. Available from: http://www.views.vcu.edu/cpdd/reports/nida_cpdd_report.pdf. [Last accessed on 2019 Mar 05].  Back to cited text no. 3
    
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7.
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Weinberger AH, Smith PH, Kaufman M, McKee SA. Consideration of sex in clinical trials of transdermal nicotine patch: A systematic review. Exp Clin Psychopharmacol 2014;22:373-83.  Back to cited text no. 9
    
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11.
Addington J, McEvoy J, Freudenreich O, McGee M, VanderZwaag C, Levin E, et al. Clozapine decreases smoking in patients with chronic schizophrenia. Biol Psychiatry 1995;37:550-2.  Back to cited text no. 11
    
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Addington J. Group treatment for smoking cessation among persons with schizophrenia. Psychiatr Serv 1998;49:925-8.  Back to cited text no. 13
    
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Schmitz JM, Rhoades H, Grabowski J. Contingent reinforcement for reduced carbon monoxide levels in methadone maintenance patients. Addict Behav 1995;20:171-9.  Back to cited text no. 14
    
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16.
Heatherton TF, Kozlowski LT, Frecker RC, Fagerström KO. The fagerström test for nicotine dependence: A revision of the fagerström tolerance questionnaire. Br J Addict 1991;86:1119-27.  Back to cited text no. 16
    
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Tidey JW, Rohsenow DJ, Kaplan GB, Swift RM, Reid N. Effects of contingency management and bupropion on cigarette smoking in smokers with schizophrenia. Psychopharmacology (Berl) 2011;217:279-87.  Back to cited text no. 17
    
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Haro JM, Kamath SA, Ochoa S, Novick D, Rele K, Fargas A, et al. The clinical global impression-schizophrenia scale: A simple instrument to measure the diversity of symptoms present in schizophrenia. Acta Psychiatr Scand Suppl 2003;416:16-23.  Back to cited text no. 18
    
19.
McEvoy J, Freudenreich O, McGee M, VanderZwaag C, Levin E, Rose J. Clozapine decreases smoking in patients with chronic schizophrenia. Biol Psychiatry 1995;37:550-2.  Back to cited text no. 19
    
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George TP, Sernyak MJ, Ziedonis DM, Woods SW. Effects of clozapine on smoking in chronic schizophrenic outpatients. J Clin Psychiatry 1995;56:344-6.  Back to cited text no. 20
    
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McEvoy JP, Freudenreich O, Wilson WH. Smoking and therapeutic response to clozapine in patients with schizophrenia. Biol Psychiatry 1999;46:125-9.  Back to cited text no. 21
    
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Bryk AS, Raudenbush SW. Application of hierarchical linear models to assessing change. Psychopharmacol Bull 1987;101:147-58.  Back to cited text no. 22
    


    Figures

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    Tables

  [Table 1], [Table 2], [Table 3]



 

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