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1.  Motivation and Patch Treatment for HIV+ Smokers: A Randomized Controlled Trial 
Addiction (Abingdon, England)  2009;104(11):1891-1900.
To test the efficacy of two smoking cessation interventions in an HIV+ sample: standard care (SC) treatment plus nicotine replacement therapy (NRT) versus more intensive motivationally-enhanced (ME) treatment plus NRT.
randomized controlled trial.
HIV+ smoker referrals from eight Immunology clinics in the Northeastern US.
444 participants enrolled in the study (mean age=42 years; 63% male; 52% European-American; mean cigarettes/day=22.8).
SC received two brief sessions with a Health Educator. Those setting a quit date received self-help quitting materials and NRT. ME received four sessions of motivational counseling and a quit-day counseling call. All ME intervention materials were tailored to the needs of HIV+ individuals.
Biochemically-verified 7-day abstinence rates at 2-month, 4-month, and 6-month follow-ups.
Intent-to-Treat (ITT) abstinence rates at 2-month, 4-month, and 6-month follow-ups were 12%, 9%, and 9% respectively in the ME condition, and 13%, 10%, and 10% respectively in the SC condition, indicating no between-group differences. Among 412 participants with treatment utilization data, 6-month ITT abstinence rates were positively associated with low nicotine dependence (p=0.02), high motivation to quit (p=0.04), and Hispanic-American race/ethnicity (p=0.02). Adjusting for these variables, each additional NRT contact improved the odds of smoking abstinence by a third (OR=1.32, 95% CI= 0.99–1.75).
Motivationally-enhanced treatment plus NRT did not improve cessation rates over and above standard care treatment plus NRT in this HIV+ sample of smokers. Providers offering brief support and encouraging use of nicotine replacement may be able to help HIV+ patients quit smoking.
PMCID: PMC2763031  PMID: 19719796
HIV; tobacco cessation; nicotine replacement; Transtheoretical Model
2.  Nicotine Replacement Therapy Patterns Of Use After A Quit Attempt Among Methadone-Maintained Smokers 
To determine the association between daily smoking and use of nicotine replacement therapy (NRT), and to determine predictors of greater NRT use among methadone-maintained smokers.
Assignment to free nicotine patch (8 to 12 weeks) plus either (1) a baseline-tailored brief motivational intervention, a quit date behavioral skills counseling session, and a relapse prevention follow-up session (max), or (2) brief advice using NCI's 4 A's model (min).
Five methadone maintenance treatment centers.
Of the 383 methadone-maintained smokers enrolled, 309 (80.6%) set a specific quit date (received NRT) and were located for assessments. Participants were 51.8% male, 78.6% Caucasian, and smoked 26.6 (SD = 12.2) cigarettes/day.
Use of NRT and smoking behaviors during the 180-day follow-up period assessed by the Timeline follow-back method.
On the day following their quit day, 86.4% of participants used NRT. The percentage of participants using NRT was 52.3%, 27.1%, and 10.4% on day 30, day 60, and day 90, respectively. Participants used NRT on 44.1% of the days through the 90 days of the treatment protocol. The estimated odds of smoking abstinence was 7.1 (P < 0.001) times higher on days when NRT was used than on days when NRT was not used, and cigarettes/day was also significantly lower on NRT days (14.93 vs 4.65; P < 0.001).
Nicotine replacement therapy use was inconsistent following an initial quit attempt among methadone-maintained smokers. On days when NRT was used, individuals were likely to smoke at reduced levels or not at all.
PMCID: PMC1924690  PMID: 16808777
methadone maintenance; clinical trial; nicotine replacement; adherence
3.  The Effects of a Multilingual Telephone Quitline for Asian Smokers: A Randomized Controlled Trial 
Although telephone counseling services (quitlines) have become a popular behavioral intervention for smoking cessation in the United States, such services are scarce for Asian immigrants with limited English proficiency. In this study, we tested the effects of telephone counseling for smoking cessation in Chinese-, Korean-, and Vietnamese-speaking smokers.
A culturally tailored counseling protocol was developed in English and translated into Chinese, Korean, and Vietnamese. We conducted a single randomized trial embedded in the California quitline service. Smokers who called the quitline’s Chinese, Korean, and Vietnamese telephone lines between August 2, 2004, and April 4, 2008, were recruited to the trial. Subjects (N = 2277) were stratified by language and randomly assigned to telephone counseling (self-help materials and up to six counseling sessions; n = 1124 subjects) or self-help (self-help materials only; n = 1153 subjects) groups: 729 Chinese subjects (counseling = 359, self-help = 370), 848 Korean subjects (counseling = 422, self-help = 426), and 700 Vietnamese subjects (counseling = 343, self-help = 357). The primary outcome was 6-month prolonged abstinence. Intention-to-treat analysis was used to estimate prolonged abstinence rates for all subjects and for each language group. All statistical tests were two-sided.
In the intention-to-treat analysis, counseling increased the 6-month prolonged abstinence rate among all smokers compared with self-help (counseling vs self-help, 16.4% vs 8.0%, difference = 8.4%, 95% confidence interval [CI] = 5.7% to 11.1%, P < .001). Counseling also increased the 6-month prolonged abstinence rate for each language group compared with self-help (counseling vs self-help, Chinese, 14.8% vs 6.0%, difference = 8.8%, 95% CI = 4.4% to 13.2%, P < .001; Korean, 14.9% vs 5.2%, difference = 9.7%, 95% CI = 5.8% to 13.8%, P < .001; Vietnamese, 19.8% vs 13.5%, difference = 6.3%, 95% CI = 0.9% to 11.9%, P = .023).
Telephone counseling was effective for Chinese-, Korean-, and Vietnamese-speaking smokers. This protocol should be incorporated into existing quitlines, with possible extension to other Asian languages.
PMCID: PMC3283535  PMID: 22282542
4.  Development of a Culturally Targeted Smoking Cessation Intervention for African American Smokers 
Journal of community health  2009;34(6):480-492.
In this paper we describe the development a culturally targeted (CT) smoking cessation intervention for low-to-middle income African–American smokers. Based on theoretically based guidelines, modifications were made to a standard treatment manual for group-based smoking cessation counseling that incorporates cognitive-behavioral, motivational, and twelve step skills. Approximately 41% of the standard treatment materials were modified, and four new modules were developed. A pilot study was conducted to compare acceptability, feasibility and early outcome indicates in African American smokers randomized to the CT intervention compared with existing data from African American smokers treated using a non-targeted standard approach (ST). Outcomes from the CT pilot study were promising: results showed high levels of feasibility, acceptability and better adherence to nicotine replacement therapy, higher quit rates, and better retention and follow-up compared with the ST. Findings suggest that a culturally targeted and intensive group based smoking cessation treatment is plausibly effective in improving smoking cessation outcomes in African American smokers, warranting a larger randomized trial.
PMCID: PMC3712791  PMID: 19728056
Culturally targeted; African American; Smoking intervention
5.  The effect of individual counseling, line follow-up, and free nicotine replacement therapy on smoking cessation in the samples of Iranian smokers: Examination of transtheoretical model 
According to transtheoretical model (TTM), Stage matched interventions are more effective in quitting. The objective of current study was to investigate the effect of individual counseling, line follow-up, and free nicotine replacement therapy (NRT) on smoking cessation in smokers who are in preparation stage of smoking.
Materials and Methods:
In a randomized clinical trial design, through sending the short message system, potential participants in preparation stage of smoking were recruited and divided into control (n = 60)and treatment (n = 50) groups. The treatment group received an in-person counseling, line follow-up, and free NRT. TTM variables trend; pros and cons of smoking, behavioral and experiential processes, temptation, were assessed at baseline, 3 and 6 months follow-up along with point prevalence and continuous abstinence.
Continuous abstinence at 6-month follow-up were 3.3% (n = 2) in control group and 46% (n = 23) in the treatment group (x2 = 34.041, P < 0.001). Time Χ group analyses indicated that except cons of smoking (P > 0.05), all TTM constructs had significantly changed; temptation (F = 36.864, P < 0.001), pros (F = 12.172, P < 0.001), experiential processes (F = 3.377, P < 0.001), and behavioral processes (F = 11.131, P < 0.001).
Interventions based on TTM variables increased the quite rate in prepared and motivated people. Our findings suggest that interventions through individual counseling along with free NRT and line follow-up in people who prepare for quitting are beneficial for our country.
PMCID: PMC3703164  PMID: 23853630
Counseling; experiential and behavioral processes; line follow-up; nicotine replacement therapy; pros and cons; quite rate; self-efficacy; smoking cessation intervention
6.  A Randomized Controlled Trial of Two Different Lengths of Nicotine Replacement Therapy for Smoking Cessation 
BioMed Research International  2013;2013:961751.
This study examined if 2-week free nicotine replacement therapy (NRT) would be more effective than 1-week free NRT to help smokers quit smoking at 6 and 12 months. In a single-blinded randomized controlled trial design, 562 Chinese smokers who attended a smoking cessation clinic in Hong Kong, China, were randomly allocated into two groups (A1 and A2): A1 (n = 284) received behavioural counselling with free NRT for 1 week; A2 (n = 278) received similar counselling with free NRT for 2 weeks. All subjects received printed self-help materials to support their quitting efforts. A structured questionnaire was used for data collection, including pattern of NRT use and self-reported 7-day point prevalence quit rate at 6 months and 12 months. Among the participants, the mean number of cigarettes smoked per day was 18.8 (SD = 10.9). By intention-to-treat analysis, 7-day point prevalence quit rates were not significantly different between A1 and A2 groups at 6-month (27.5% versus 27.3%; P = 0.97) and 12-month (21.1% versus 21.2%; P = 0.98) followup. The findings suggest that two-week free NRT was not more effective than 1-week free NRT to increase smoking cessation rate among Chinese smokers.
PMCID: PMC3782125  PMID: 24089693
7.  Trial Protocol: Using genotype to tailor prescribing of nicotine replacement therapy: a randomised controlled trial assessing impact of communication upon adherence 
BMC Public Health  2010;10:680.
The behavioural impact of pharmacogenomics is untested; informing smokers of genetic test results for responsiveness to smoking cessation medication may increase adherence to this medication. The objective of this trial is to estimate the impact upon adherence to nicotine replacement therapy (NRT) of informing smokers that their oral dose of NRT has been tailored to a DNA analysis. Hypotheses to be tested are as follows:
I Adherence to NRT is greater among smokers informed that their oral dose of NRT is tailored to an analysis of DNA (genotype), compared to one tailored to nicotine dependence questionnaire score (phenotype).
II Amongst smokers who fail to quit at six months, motivation to make another quit attempt is lower when informed that their oral dose of NRT was tailored to genotype rather than phenotype.
An open label, parallel groups randomised trial in which 630 adult smokers (smoking 10 or more cigarettes daily) using National Health Service (NHS) stop smoking services in primary care are randomly allocated to one of two groups:
i. NRT oral dose tailored by DNA analysis (OPRM1 gene) (genotype), or
ii. NRT oral dose tailored by nicotine dependence questionnaire score (phenotype)
The primary outcome is proportion of prescribed NRT consumed in the first 28 days following an initial quit attempt, with the secondary outcome being motivation to make another quit attempt, amongst smokers not abstinent at six months. Other outcomes include adherence to NRT in the first seven days and biochemically validated smoking abstinence at six months. The primary outcome will be collected on 630 smokers allowing sufficient power to detect a 7.5% difference in mean proportion of NRT consumed using a two-tailed test at the 5% level of significance between groups. The proportion of all NRT consumed in the first four weeks of quitting will be compared between arms using an independent samples t-test and by estimating the 95% confidence interval for observed between-arm difference in mean NRT consumption (Hypothesis I). Motivation to make another quit attempt will be compared between arms in those failing to quit by six months (Hypothesis II).
This is the first clinical trial evaluating the behavioural impact on adherence of prescribing medication using genetic rather than phenotypic information. Specific issues regarding the choice of design for trials of interventions of this kind are discussed.
Trial details
Funder: Medical Research Council (MRC)
Grant number: G0500274
ISRCTN: 14352545
Date trial stated: June 2007
Expected end date: December 2009
Expected reporting date: December 2010
PMCID: PMC2996370  PMID: 21062464
8.  Smoking Characteristics and Comorbidities in the Power To Quit Randomized Clinical Trial for Homeless Smokers 
Nicotine & Tobacco Research  2012;15(1):22-28.
Smoking prevalence in homeless populations is strikingly high (∼70%); yet, little is known about effective smoking cessation interventions for this population. We conducted a community-based clinical trial, Power To Quit (PTQ), to assess the effects of motivational interviewing (MI) and nicotine patch (nicotine replacement therapy [NRT]) on smoking cessation among homeless smokers. This paper describes the smoking characteristics and comorbidities of smokers in the study.
Four hundred and thirty homeless adult smokers were randomized to either the intervention arm (NRT + MI) or the control arm (NRT + Brief Advice). Baseline assessment included demographic information, shelter status, smoking history, motivation to quit smoking, alcohol/other substance abuse, and psychiatric comorbidities.
Of the 849 individuals who completed the eligibility survey, 578 (68.1%) were eligible and 430 (74.4% of eligibles) were enrolled. Participants were predominantly Black, male, and had mean age of 44.4 years (S D = 9.9), and the majority were unemployed (90.5%). Most participants reported sleeping in emergency shelters; nearly half had been homeless for more than a year. Nearly all the participants were daily smokers who smoked an average of 20 cigarettes/day. Nearly 40% had patient health questionnaire-9 depression scores in the moderate or worse range, and more than 80% screened positive for lifetime history of drug abuse or dependence.
This study demonstrates the feasibility of enrolling a diverse sample of homeless smokers into a smoking cessation clinical trial. The uniqueness of the study sample enables investigators to examine the influence of nicotine dependence as well as psychiatric and substance abuse comorbidities on smoking cessation outcomes.
PMCID: PMC3611988  PMID: 22589422
9.  Understanding and Use of Nicotine Replacement Therapy and Nonpharmacologic Smoking Cessation Strategies Among Chinese and Vietnamese Smokers and Their Families 
Population-based studies have reported high rates of smoking prevalence among Chinese and Vietnamese American men. Although nicotine replacement therapy (NRT) is effective, recommended, and accessible without prescription, these populations underuse NRT for smoking cessation. The aim of this study was to assess understanding and use of NRT and nonpharmacologic treatments among Chinese and Vietnamese American male smokers and their families.
In-depth qualitative interviews were conducted with 13 smoker–family pairs, followed by individual interviews with each participant. A total of 39 interviews were conducted in Vietnamese or Chinese, recorded, translated, and transcribed into English for analysis.
Four themes were identified: use and understanding of NRT, nonpharmacologic strategies, familial and religious approaches, and willpower. Both smokers and their family members believed strongly in willpower and a sense of personal responsibility as the primary drivers for stopping smoking. Lack of these 2 qualities keeps many Chinese and Vietnamese men from using NRT to quit smoking. Those who do use NRT often use it incorrectly, following their own preferences rather than product instructions.
Our findings indicate the importance of culturally appropriate patient education about NRT. It may be necessary to teach smokers and their families at an individual level about NRT as a complementary approach that can strengthen their resolve to quit smoking. At a community level, public health education on the indication and appropriate use of evidence-based smoking cessation resources, such as NRT, would be an important component of effective tobacco control.
PMCID: PMC3938957  PMID: 24556252
10.  Costs and benefits of smoking cessation aids: making a case for public reimbursement of nicotine replacement therapy in Australia 
Tobacco Control  2007;16(4):255-260.
Tobacco smoking is the leading preventable cause of morbidity and mortality in Australia and other developed countries. Of the pharmacological aids that are available for smoking cessation, bupropion (Zyban SR) is eligible for public reimbursement on the Australian Pharmaceutical Benefits Scheme (PBS), whereas nicotine replacement therapy (NRT) is not. Information on the cost‐effectiveness and financial impact of public reimbursement of these strategies can better inform debate about their inclusion or exclusion in public reimbursement schemes.
To estimate the cost‐effectiveness of bupropion and NRT, and the potential financial impact of public reimbursement of NRT in Australia.
A cost‐effectiveness analysis using a deterministic Markov model, and cost per disability‐adjusted life year (DALY) averted over a lifetime as the outcome measure.
Current smokers, motivated to quit, in Australia in 2000.
(1) NRT; (2) bupropion; and (3) a combined strategy using bupropion as the first‐line treatment and NRT in those who fail to quit smoking or have adverse reactions to bupropion.
Quitting smoking can increase life expectancy of current smokers by 1–7.6 years depending on age at cessation and sex. Providing bupropion to current smokers who are motivated to quit would cost A$7900 (95% uncertainty interval A$6000 to A$10 500) for each DALY averted; NRT patches would cost A$17 000 (A$9000 to A$28 000) for each DALY averted, with similar results even if used as a second‐line treatment following initial failure to quit using bupropion. If 6% of current smokers were to use NRT following inclusion on the PBS, this would result in an annual cost of A$40–110 million to the PBS depending on the listed price.
Compared with other drugs included on the PBS, bupropion and NRT are both highly cost‐effective smoking cessation interventions, and including NRT on the PBS would have a moderate financial impact. Given the sizeable health burden of smoking, and the large individual benefits of quitting smoking, increasing the availability of alternative aids and uptake of these strategies through public reimbursement would be a positive and rational step towards further reducing tobacco‐related disease burden in Australia and other countries where NRT is currently not subsidised.
PMCID: PMC2598534  PMID: 17652241
11.  Addressing Challenges in Adolescent Smoking Cessation: Design and Baseline Characteristics of the HS Group-Randomized Trial 
Preventive medicine  2007;45(2-3):215-225.
Well-documented challenges have hampered both intervention development and research in teen smoking cessation. Addressing these challenges, the Hutchinson Study of High School Smoking (HS Study), the largest group-randomized trial in adolescent smoking cessation to date, incorporates several design innovations to investigate the effect of a counselor-initiated, individually tailored telephone counseling smoking cessation intervention for older adolescents. This paper presents and discusses these innovative design features, and baseline findings on the resulting study population.
The trial used a population-based survey to proactively identify and recruit all high school juniors who had smoked in the past month—potentially expanding intervention reach to all smokers, even those who smoked less than daily and those not motivated to quit. For ethical and intervention reasons, some nonsmokers were enrolled in the intervention, also. Other important design features included the random allocation of schools into experimental conditions (intervention vs. no-intervention control) and a multi-wave design.
Results & Conclusion
The design innovations address problems and challenges identified in adolescent smoking cessation literature. The heterogeneous baseline characteristics of the study population, well-balanced between the two arms, have three significant implications: They (1) demonstrate the effectiveness of the trial’s design features, (2) highlight several intervention-related issues, and (3) provide assurance that the trial’s evaluation of intervention effectiveness will be unbiased.
PMCID: PMC2040060  PMID: 17628650
adolescent; smoking cessation; randomized trial; group-randomized; cessation intervention; proactive intervention; telephone counseling; youth
12.  Correlates of Smoking Cessation Self-efficacy in a Community Sample of Smokers1 
Addictive behaviors  2009;35(2):175-178.
While numerous studies show that higher levels of smoking cessation self-efficacy predicts motivation to quit smoking and successful smoking cessation, few studies have evaluated factors related to smoking cessation self-efficacy that could be targets of behavioral interventions to promote greater confidence to quit smoking. This study, using a large community sample of smokers enrolled in a smoking cessation treatment program, evaluated potential associations between self-efficacy to quit smoking and demographic (e.g., age, race), smoking-related (e.g., rate, cessation history, past use of treatments), and psychosocial (e.g., stress, cue reactivity, self-medication smoking) variables. The results indicated that Hispanic-American smokers, relative to smokers of other racial/ethnic groups, report significantly lower self-efficacy to quit smoking when facing internal stimuli (e.g., feeling depressed), as do smokers who report that they have little confidence to control abstinence-induced symptoms (F(9,576) = 6.9, p < .001). The results also indicated that smokers who reported that they have little confidence to control abstinence-induced symptoms and report high smoking urge reactivity to situations that illicit positive affect (e.g., at a bar, with coffee, at a party) report lower self-efficacy to quit smoking when facing external stimuli (e.g., during a celebration; F[7,600] = 9.05, p < .05). These findings can be used to refine behavioral smoking cessation interventions to increase self-efficacy to quit smoking.
PMCID: PMC2783543  PMID: 19804945
self-efficacy; smoking; tobacco; perceived control; cue reactivity
13.  Distinct Beliefs, Attitudes, and Experiences of Latino Smokers: Relevance for Cessation Interventions 
Determine the extent to which Latino smokers are using effective interventions for smoking cessation, with particular focus on nicotine replacement therapy (NRT). Related aims were to explore cultural, attitudinal, knowledge, and socioeconomic variables associated with treatment use.
Cross-sectional telephone survey of two groups of Colorado adult smokers: Latinos (n = 1010) and non-Latino whites (n = 519).
Computer-assisted telephone survey in either Spanish or English. Survey addressed sociodemographic variables; smoking and cessation history; knowledge, attitudes, and beliefs about smoking and quitting; and experiences in and attitudes toward the health care setting.
Latino and non-Latino white adult Colorado residents who reported being regular smokers.
Colorado Latinos report using NRT substantially less often than do non-Latino whites residing in the state. This and other differences in the study were more pronounced in Latinos characterized as low acculturation on the basis of a language preference variable. Latinos smoke somewhat less than non-Latino whites and report lower levels of dependence. They appear to be motivated to quit but endorse attitudes and beliefs antithetical to NRT use. Health care access was lower among Latinos, and this was related to lower reports of lifetime NRT use. Receipt of recommended practitioner intervention (the “five As”) did not differ by ethnicity.
Results suggested that use of effective cessation interventions among Latinos may be enhanced by education about nicotine addiction and NRT. Policy change to increase health care access also showed promise.
PMCID: PMC3166215  PMID: 21510796
Cigarette Smoking; Hispanic Americans; Culture; Acculturation; Smoking Cessation; Prevention Research
14.  Immediate and short-term impact of a brief motivational smoking intervention using a biomedical risk assessment: The Get PHIT trial 
Nicotine & Tobacco Research  2009;11(4):394-403.
Providing smokers with biologically based evidence of smoking-related disease risk or physical impairment may be an effective way to motivate cessation.
Smokers were recruited for a free health risk assessment and randomized to receive personally tailored feedback based on their lung functioning, carbon monoxide (CO) exposure, and smoking-related health conditions or generic information about the risks of smoking and personalized counseling based on their diet, body mass index, and physical activity. All (n = 536) were advised to quit smoking and offered access to a free telephone cessation program. Participants were surveyed immediately after intervention and 1 month later to assess the impact on various indices of motivation to quit.
Immediately posttreatment, experimental participants rated themselves as more likely to try to quit (p = .02) and reported a greater mean increase in their motivation to quit than controls (p = .04). At 1-month follow-up, however, we found no significant group differences on any motivational indices. In post-hoc analyses comparing smokers in the experimental group with and without lung impairment, persons with impaired lung functioning had a greater change from baseline in posttreatment motivation to quit (adjusted p = .05) and perceived risk of developing a smoking-related disease (p = .03) compared with persons with no lung impairment, but we found no significant treatment effect on any motivational indices at 1 month.
The results suggest that the intervention had a small, temporary effect, but we found no clear evidence that the intervention increased motivation to quit smoking during the first month postintervention.
PMCID: PMC2670368  PMID: 19299409
15.  Cigarette smokers' intention to quit smoking in Dire Dawa town Ethiopia: an assessment using the Transtheoretical Model 
BMC Public Health  2010;10:320.
Cessation of smoking reduces morbidity and mortality related to tobacco smoking. It is essential to explore the intention of individuals to quit smoking to design effective interventions. The objective of this study was to assess cigarette smokers' intention to quit smoking in Dire Dawa town using the Transtheoretical model.
From February 15 to 19, 2009, we conducted a community based cross-sectional study among 384 current cigarette smokers in Dire Dawa town east Ethiopia. Data was collected by trained personnel using a pretested structured questionnaire. The data was analyzed using SPSS version 16.0.
Two hundred and nineteen (57%) smokers in the study area had the intention to quit cigarette smoking within the next six months and all the process of change had an increasing trend across the stages. Based on the Fragestrom test of nicotine dependence of cigarette, 35 (9.1%), 69 (18%) and 48(12.5%) were very high, high and medium dependent on nicotine respectively. For the majority 247(64.3%) of the respondents, the mean score of cons of smoking outweighs the pros score (negative decisional balance). Only 66(17.2%) had high self efficacy not to smoke in places and situations that can aggravate smoking.
Majority of the smokers had the intention to quit smoking. All the process of change had an increasing trend across the stages. Those who had no intention to quit smoking had high level of dependence on nicotine and low self efficacy. The pros of smoking were decreasing while the cons were increasing across the stages. Stage based interventions should be done to move the smokers from their current stage to an advanced stages of quitting cigarette smoking.
PMCID: PMC2889871  PMID: 20529337
16.  Financial incentives for smoking cessation in low-income smokers: study protocol for a randomized controlled trial 
Trials  2012;13:88.
Tobacco smoking is the leading avoidable cause of death in high-income countries. The smoking-related disease burden is borne primarily by the least educated and least affluent groups. Thus, there is a need for effective smoking cessation interventions that reach to, and are effective in this group. Research suggests that modest financial incentives are not very effective in helping smokers quit. What is not known is whether large financial incentives can enhance longer-term (1 year) smoking cessation rates, outside clinical and workplace settings.
Trial design
A randomized, parallel groups, controlled trial.
Participants: Eight hundred low-income smokers in Switzerland (the less affluent third of the population, based on fiscal taxation).
Intervention: A smoking cessation program including: (a) financial incentives given during 6 months; and (b) Internet-based counseling. Financial rewards will be offered for biochemically verified smoking abstinence after 1, 2, and 3 weeks and 1, 3, and 6 months, for a maximum of 1,500 CHF (1,250 EUR, 1,500 USD) for those abstinent at all time-points. All participants, including controls, will receive Internet-based, individually-tailored, smoking cessation counseling and self-help booklets, but there will be no in-person or telephone counseling, and participants will not receive medications. The control group will not receive financial incentives.
Objective: To increase smoking cessation rates.
Outcome: Smoking abstinence after 6 and 18 months, not contradicted by biochemical tests. We will assess relapse after the end of the intervention, to test whether 6-month effects translate into sustained abstinence 12 months after the incentives are withdrawn.
Randomization: Will be done using sealed envelopes drawn by participants.
Blinding: Is not possible in this context.
Smoking prevention policies and interventions have been least effective in the least educated, low-income groups. Combining financial incentives and Internet-based counseling is an innovative approach that, if proven acceptable and effective, could be later implemented on a large scale at a reasonable cost, decrease health disparities, and save many lives.
Trial registration
Current Controlled Trials ISRCTN04019434.
PMCID: PMC3526393  PMID: 22721577
Financial incentives; Smoking; Smoking cessation
17.  Attitudes and practices of African-American women regarding cigarette smoking: implications for interventions. 
It has been projected that beyond 1995, African-American women will have the highest prevalence of tobacco smoking. This study, therefore, was undertaken to explore the beliefs, attitudes, and practices among African Americans regarding tobacco smoking so as to design more culturally appropriate smoking cessation interventions. Focus group discussions were conducted with 42 African-American women (31 ever smokers and 11 never smoked) exploring in-depth: 1) knowledge of the health consequences of smoking, 2) attitudes about the acceptability of smoking and personal reasons for smoking, 3) smoking practices, and 4) opinions about the necessary components of smoking cessation programs. Compared with nonsmokers, current smokers have not yet personalized the distant threat of smoking due to the very powerful immediate benefit obtained from the nicotine present in tobacco--the decrease in anxiety, tension, and depression, ie, "stress reduction." There is also a perception of powerful barriers to smoking cessation, ie, no internal mechanisms for stress modulation. Smoking cessation intervention programs must have culturally proficient psychoeducational components to address the cognitive and behavioral dysfunction associated with smoking. For those smokers with evidence of difficulty modulating dysphoria or tension, they also must address the possible underlying biochemical dysregulation.
PMCID: PMC2607667  PMID: 8046759
18.  Using a quitline plus low-cost nicotine replacement therapy to help disadvantaged smokers to quit 
Tobacco Control  2009;18(2):144-149.
To trial an intervention in a real-life setting to motivate low-income smokers to try to quit. The intervention under trial was the addition of subsidised nicotine replacement therapy (NRT) to a standard population quitline service.
Participants were low-income smokers, recruited “cold” via either a letter in the mail or a flyer inserted in a local newspaper. The intervention group received the usual service of multisession counselling from the quitline plus access to heavily subsidised NRT. A comparison group received the usual quitline service only. Participants were followed up at 3, 6, and 12 months. Trial participants were also compared with a sample of general callers to the quitline.
The offer of subsidised NRT recruited more than twice as many low-income smokers than the offer of the cessation service alone (intervention group n = 1000; comparison group n = 377). 63% were first-time callers to the quitline. Intervention respondents showed higher levels of nicotine dependence than comparison group respondents. Comparisons of quitting data were confounded by the differences in the respondents at baseline. 73.5% of smokers in the intervention group tried to quit compared to 61.0% in the comparison group. Unadjusted quit rates were higher in the intervention group than in the comparison group at 3 months and 6 months but not at 12 months.
Disadvantaged smokers were easily engaged to call the quitline, particularly when offered subsidised NRT. Disadvantaged smokers using the quitline, with and without subsidised NRT, achieved cessation outcomes comparable to other studies of “mainstream” smokers.
PMCID: PMC2655041  PMID: 19131454
19.  Institutionalizing a Comprehensive Tobacco-Cessation Protocol in an Indigenous Health System: Lessons Learned 
Native Hawaiians have high smoking prevalence and high lung cancer mortality rates.
To describe a comprehensive tobacco cessation protocol and share lessons learned in institutionalizing it across the five Native Hawaiian Health Care Systems (NHHCS).
NHHCS representatives worked together to culturally tailor the Agency for Healthcare Research and Quality protocol for smoking cessation. Process objectives included number of staff trained in tobacco cessation, inclusion of the Tobacco User Guide Sheet (TUGS) in the intake process and medical record, and expansion of programs for smokers who want to quit. Outcome objectives included percent of individuals asked about smoking status and percent of identified smokers that received brief intervention, set a quit date, were linked to services, and remained smoke-free for 90 days.
After 18 months, the NHHCS were at different stages of protocol adoption. More successful NHHCS were more likely to have several champions for the program and administrative support for staff training, new programs, and integrating the TUGS into client charts. They also showed greater success in getting smokers to set a quit date and remain smoke-free for 90 days.
Although the five NHHCS helped design the protocol, each operates independently. More effort and time are needed to help each system overcome internal barriers to institutionalizing a new protocol and to facilitate support for tobacco-cessation champions among medical records and data management supervisors. These lessons may be useful to other organizations that want to institutionalize a comprehensive tobacco-cessation protocol.
PMCID: PMC2862696  PMID: 20208308
Community health centers; guideline adherence; minority; nicotine; organizational change; organizational innovation; Native Hawaiian; Pacific Islander; smoking
20.  Nicotine Replacement Therapy Use at Home After Use During a Hospitalization 
Nicotine & Tobacco Research  2011;14(7):885-889.
We assessed whether providing inpatient smokers with nicotine replacement therapy (NRT) to relieve withdrawal symptoms while hospitalized was associated with self-initiated NRT use soon after hospital discharge.
We conducted an observational study of 1,895 cigarette smokers admitted to a large hospital over 24 months (July 2007 through June 2009) and seen by a tobacco counselor during hospitalization. Participants were surveyed at 2 weeks after discharge to assess postdischarge NRT use. We calculated adjusted rate ratios (ARRs) for the effect of NRT use in the hospital on the rate of NRT use after discharge, adjusting for gender, age, hospital service, intention to quit, baseline smoking level, length of stay, and counseling duration.
62 percent (1,166/1,895) of enrolled participants received NRT during hospitalization. The survey response rate was 72%. 42 percent (544/1,293) of survey respondents reported initiating postdischarge NRT use within 2 weeks of discharge. NRT use after discharge was more likely to be reported by those who used it in hospital whether they had ever used it prior to hospitalization (ARR: 5.64, 95% CI: 3.95–8.05) or had never used it before (ARR: 4.68, 95% CI: 3.25–6.73).
Smokers who received NRT during a hospitalization were more likely to use it after discharge compared with those who did not use NRT in hospital. By encouraging use of this effective cessation aid, supplementing counseling with NRT for hospitalized smokers may promote smoking cessation efforts after discharge.
PMCID: PMC3390546  PMID: 22121242
21.  Predictors of Quitting Among African American Light Smokers Enrolled in a Randomized, Placebo-Controlled Trial 
This study examined the baseline predictors of abstinence among African American (AA) light smokers enrolled in a randomized smoking cessation trial. At 6 months post-baseline, participants were more likely to have quit smoking if they were older, had a higher body mass index, and received directive, advice oriented as opposed to motivational enhancement counseling. Participants were less likely to quit if they were female, had a lower income, greater baseline nicotine exposure, and did not complete all counseling sessions. Individual factors make quitting difficult; however directive, advice-oriented counseling may be an effective method for increasing quitting among AA light smokers.
PMCID: PMC1924638
22.  Within a smoking-cessation program, what impact does genetic information on lung cancer need to have to demonstrate cost-effectiveness? 
Many smoking-cessation programs and pharmaceutical aids demonstrate substantial health gains for a relatively low allocation of resources. Genetic information represents a type of individualized or personal feedback regarding the risk of developing lung cancer, and hence the potential benefits from stopping smoking, may motivate the person to remain smoke-free. The purpose of this study was to explore what the impact of a genetic test needs to have within a typical smoking-cessation program aimed at heavy smokers in order to be cost-effective.
Two strategies were modelled for a hypothetical cohort of heavy smokers aged 50 years; individuals either received or did not receive a genetic test within the course of a usual smoking-cessation intervention comprising nicotine replacement therapy (NRT) and counselling. A Markov model was constructed using evidence from published randomized controlled trials and meta-analyses for estimates on 12-month quit rates and long-term relapse rates. Epidemiological data were used for estimates on lung cancer risk stratified by time since quitting and smoking patterns. Extensive sensitivity analyses were used to explore parameter uncertainty.
The discounted incremental cost per QALY was AU$34,687 (95% CI $12,483, $87,734) over 35 years. At a willingness-to-pay of AU$20,000 per QALY gained, the genetic testing strategy needs to produce a 12-month quit rate of at least 12.4% or a relapse rate 12% lower than NRT and counselling alone for it to be equally cost-effective. The likelihood that adding a genetic test to the usual smoking-cessation intervention is cost-effective was 20.6% however cost-effectiveness ratios were favourable in certain situations (e.g., applied to men only, a 60 year old cohort).
The findings were sensitive to small changes in critical variables such as the 12-month quit rates and relapse rates. As such, the cost-effectiveness of the genetic testing smoking cessation program is uncertain. Further clinical research on smoking-cessation quit and relapse rates following genetic testing is needed to inform its cost-effectiveness.
PMCID: PMC2949618  PMID: 20843376
23.  Intensive Intervention for Alcohol-Dependent Smokers in Early Recovery: A Randomized Trial 
Drug and Alcohol Dependence  2011;122(3):186-194.
The purpose of this study was to investigate the efficacy of an intensive tobacco cessation intervention for alcohol-dependent smokers in early recovery.
A total of 162 alcohol-dependent smokers were randomized to either intensive intervention for smoking cessation or usual care. The intensive intervention consisted of 16 sessions of individual cognitive behavior therapy (CBT) and combination nicotine replacement therapy that lasted 26 weeks. Usual care involved referral to a free-standing smoking cessation program that provided smoking cessation counseling of varying duration and guideline-concordant medications. The primary cessation outcome was verified 7-day point prevalence abstinence (PPA) at 12, 26, 38, and 52 weeks.
At 12 and 26 weeks, the verified 7-day point-prevalence quit rate was significantly higher for the intensive intervention group than for the usual care group (both p = .03). However, the quit rates for the two treatment groups were not significantly different at 38 or 52 weeks. Verified 30-day alcohol abstinence rates were not significantly different for the two treatment groups at any of the follow-up assessments.
The intensive smoking cessation intervention yielded a higher short-term smoking quit rate without jeopardizing sobriety. A chronic care model might facilitate maintenance of smoking cessation during the first year of alcohol treatment and perhaps for longer periods of time. It is hoped that studies such as this will inform the development of more effective interventions for concurrent alcohol and tobacco use disorders.
PMCID: PMC3288470  PMID: 22014532
Smoking cessation; tobacco use; alcohol dependence; concurrent intervention; early recover
24.  Protocol for the Proactive Or Reactive Telephone Smoking CeSsation Support (PORTSSS) trial 
Trials  2009;10:26.
Telephone quit lines are accessible to many smokers and are used to engage motivated smokers to make quit attempts. Smoking cessation counselling provided via telephone can either be reactive (i.e. primarily involving the provision of evidence-based information), or proactive (i.e. primarily involving repeated, sequenced calls from and interaction with trained cessation counsellors). Some studies have found proactive telephone counselling more effective and this trial will investigate whether or not proactive telephone support for smoking cessation, delivered through the National Health Service (NHS) Smoking Helpline is more effective or cost-effective than reactive support. It will also investigate whether or not providing nicotine replacement therapy (NRT), in addition to telephone counselling, has an adjunctive impact on smoking cessation rates and whether or not this is cost effective.
This will be a parallel group, factorial design RCT, conducted through the English national NHS Smoking Helpline which is run from headquarters in Glasgow. Participants will be smokers who call the helpline from any location in England and who wish to stop smoking. If 644 participants are recruited to four equally-sized trial groups (total sample size = 2576), the trial will have 90% power for detecting a treatment effect (Odds Ratio) of 1.5 for each of the two interventions: i) proactive versus reactive support and ii) the offer of NRT versus no offer. The primary outcome measure for the study is self-reported, prolonged abstinence from smoking for at least six months following an agreed quit date. A concurrent health economic evaluation will investigate the cost effectiveness of the two interventions when delivered via a telephone helpline.
The PORTSSS trial will provide high quality evidence to determine the most appropriate kind of counselling which should be provided via the NHS Smoking Helpline and also whether or not an additional offer of cost-free NRT is effective and cost effective for smoking cessation.
Trial Registration
( NCT00775944
PMCID: PMC2679731  PMID: 19400961
25.  Patterns of Tobacco-Use Behavior Among Chinese Smokers with Medical Conditions 
Journal of Community Health  2009;34(6):472-479.
Understanding the characteristics of Chinese American smokers with medical conditions and factors associated with their tobacco-use behaviors will guide effective cessation programs. In 2008, the authors described socio-demographic profiles of Chinese smokers with medical conditions treated during the period 2002–2006, documented their tobacco-use behaviors (i.e., average daily cigarette use, nicotine dependence, and number of past-year quit attempts), and drew comparisons between subjects recruited from hospitals (IP) and ambulatory settings (OP). Compared to OP, IP were significantly older, less educated, less acculturated, and more likely to be retired. Of the two groups, IP had poorer disease profiles, smoked less (4.4 vs. 11.9 cigarettes per day), and had lower nicotine-addiction scores (5.5 vs. 6.7). There was no difference between groups in past-year quit attempts. After adjustments, the data revealed that being employed and OP was associated with higher average daily cigarette use; IP were less nicotine dependent than OP; and for both groups, years of smoking was negatively associated with past-year quit attempts. Our study suggests that, more than acculturation level, health status influences the Chinese smoker’s level of cigarette use and nicotine addiction. Given the severity of their disease profiles, IP should be aggressively targeted for intervention, as they are more likely to be light smokers and to be less nicotine dependent than OP. Future tobacco treatment studies should pay attention to health status among smokers in health-care settings in order to provide a more accurate assessment of treatment needs and of barriers to successful smoking cessation.
PMCID: PMC2778788  PMID: 19707860
Chinese American; Smoking cessation; Health status; Tobacco-use behaviors

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