Lisa Sanderson Cox

Nicotine dependence treatment for patients with cancer

Cancer patients who use tobacco demonstrate characteristics of strong nicotine dependence and are at increased risk for future tobacco‐related morbidity and mortality. Continued smoking may contribute to poorer cancer treatment outcome and additional illness. In contrast, stopping smoking may improve quality of life and facilitate cancer treatment. Unfortunately, limited attention has been given to addressing tobacco use and treating nicotine dependence in cancer patients.

Effect of varying levels of disease management on smoking cessation: a randomized trial.

Context Smoking cessation is difficult and may require repeated or intensive interventions. Contribution In this multicenter trial, 750 primary care patients who smoked at least 10 cigarettes per day were randomly assigned to pharmacotherapy (nicotine patch or bupropion), pharmacotherapy supplemented with up to 2 calls from trained counselors, or pharmacotherapy supplemented with up to 6 counseling calls. Utilization of the interventions, which were offered every 6 months for 2 years, declined over time. Smoking abstinence rates at 2 years were 23%, 24%, and 28% in the 3 groups. Caution Pharmacotherapy was free. Smoking abstinence was self-reported. The Editors Cigarette smoking is a chronic illness characterized by repeated cycles of quit attempts and relapse. Most models for addressing smoking cessation are based on single, short-term interventions lasting only a few weeks or months (1). Although most smokers will not quit after a single intervention, few studies have addressed the chronic nature of nicotine dependence by providing systematic, repetitive treatment opportunities (1). Providing treatment only to smokers who are already prepared to quit further limits the reach of current smoking cessation interventions (2). New models of chronic disease care might provide an alternative approach for expanding the reach and effectiveness of smoking cessation efforts (3). Physicians are in direct contact with approximately 70% of smokers each year (4, 5). Their potential role in promoting smoking cessation has been well delineated and incorporated into current clinical practice guidelines (1). With the development of new, more effective prescription pharmacotherapy for smoking cessation, the role of primary care practices in promoting smoking cessation is now more important than ever. Unfortunately, only half of the smokers who see their physicians are asked about their smoking (6), and even fewer receive advice from their health care provider to quit or receive pharmacotherapy or follow-up (4, 7). Smoking cessation counseling competes with other pressing clinical tasks, and beyond brief advice, many physicians feel they are too busy to routinely and repeatedly counsel participants who smoke (810). To assist primary care physicians in the treatment of rural smokers, we developed KanQuit, a smoking cessation program based on the chronic care model (4), which integrates principles of disease management into the treatment of smokers seen in rural primary care. Our objective was to enroll smokers, regardless of their willingness to quit, into a disease registry and compare cessation rates among smokers who received pharmacotherapy alone or combined with either moderate-intensity or high-intensity disease management that includes counseling and provider feedback. Methods Design Overview We did a randomized, single-blind trial of varying levels of disease management for smoking cessation. We recruited participants who smoked more than 10 cigarettes per day from rural primary care clinics across Kansas and randomly assigned them to receive pharmacotherapy alone, pharmacotherapy supplemented by 1 to 2 counseling calls every 6 months (moderate-intensity disease management), or pharmacotherapy supplemented by up to 6 counseling calls every 6 months (high-intensity disease management). For recipients of moderate-intensity and high-intensity disease management, we faxed periodic progress reports to their physician. We offered all participants free pharmacotherapy (either bupropion or transdermal nicotine patch) every 6 months. We enrolled participants from June 2004 to October 2005 and followed them for 24 months, completing follow-up in December 2007. All participants provided written informed consent. The University of Kansas Medical Centers Human Subjects Committee approved the study. Setting and Participants We conducted our study in 50 rural primary care practices in the Kansas Physicians Engaged in Prevention Research network (11). As part of a rural primary care research experience, trained medical students systematically screened participants, identified smokers, and recruited them for this study, regardless of their interest in quitting (12). We considered smokers eligible if they had a primary care physician who participated in this study; were older than 18 years; smoked more than 10 cigarettes per day for at least 1 year and for at least 25 of the past 30 days; spoke English; and had a telephone. We excluded smokers if they were pregnant or planned to become pregnant, planned to move out of the study area, had signs of dementia or mental illness that would preclude participation, or lived with a smoker already enrolled in the study. Of the 1827 smokers we screened, 61% met criteria for study entry (Figure 1). Of these, we enrolled 67%. Figure 1. Study flow diagram. HDM = high-intensity disease management; MDM = moderate-intensity disease management; PM = pharmacotherapy management. Randomization and Interventions Participant Randomization Randomization occurred at the participant level. A computer-generated random-number table was used to generate allocation cards in blocks of 24, with allocation equally distributed across treatment groups. To conceal allocation, we placed these cards in sequentially numbered, opaque, sealed envelopes. After research assistants verified participant eligibility and completed the baseline assessment, the project director opened the next sequential sealed envelope and determined the participants treatment allocation. One of 9 counselors trained in smoking cessation and motivational interviewing (12) conducted all interventions from a single central site. We assigned participants to counselors without regard to practice site. Pharmacotherapy At baseline, all smokers received a health education mailing that consisted of a welcome letter, information about the use of bupropion and the nicotine patch for smoking cessation, and copies of You Can Quit Smoking: Consumer Guide (13) and When Smokers QuitThe Health Benefits Over Time (14). At baseline and at 6, 12, and 18 months, participants received a mailed offer for free pharmacotherapy that consisted of either a 6-week course of a nicotine patch (21 mg/d) or a 7-week course of sustained-release bupropion (150 mg twice daily). Participants interested in using either medication could return a postage-paid postcard or call a toll-free number. We screened all participants who requested pharmacotherapy for potential contraindications (15). Participants with absolute contraindications for a given drug were ineligible to receive that drug but were offered the option of receiving the other drug. Participants with contraindications to both drugs were not eligible to receive medication from the study but could participate in all other aspects of the intervention. For participants who requested bupropion and those with relative contraindications to the nicotine patch, research staff faxed a prescription request to their primary care physicians. This prescription request delineated any relative contraindications or potential drug interactions. For these participants, their physicians made the final assessment of the appropriateness of the bupropion or the patch. For participants without contraindications to the nicotine patch or on receipt of a faxed, signed prescription, the bupropion or patches were mailed to the participant along with instructions for use. Disease Management In addition to pharmacotherapy, the moderate-intensity and high-intensity disease management groups received educational support, telephone counseling, and periodic progress reports with counseling suggestions faxed to their physician. Every 6 months, they received a KanQuit newsletter that addressed tips on quitting smoking, talking with their physician about smoking, and using pharmacotherapy for cessation. The newsletters were personalized to include study updates, counselor photographs, physician feature stories, and testimonials of participants who had quit smoking. We offered participants assigned to moderate-intensity disease management up to 2 telephone-based counseling sessions every 6 months (1 session to promote a quit attempt and 1 additional follow-up session for those who made a quit attempt). We offered participants assigned to high-intensity disease management up to 6 counseling calls every 6 months to either promote quitting or prevent relapse. We scheduled calls at the participants convenience, and they varied according to the participants quit plan but followed a rough schedule of calls at 1, 3, 6, 9, and 16 weeks after the onset of each 6-month treatment cycle. Counselors used motivational interviewing techniques and followed a semistructured protocol to promote a cessation attempt or, for abstinent smokers, to encourage relapse prevention. During counseling calls, case managers reminded participants about the availability of pharmacotherapy and, for interested participants, provided immediate support for acquiring either the nicotine patch or bupropion, as described previously. We faxed personalized progress reports with suggestions for interventions to the participants physician after the first counseling call (both moderate-intensity and high-intensity disease management participants) and after the last counseling call (high-intensity disease management participants only) during each 6-month cycle. We faxed additional progress reports to the participants physician whenever the moderate-intensity or high-intensity disease management participant set a quit date. Outcomes, Measurements, and Follow-up Research assistants who were blinded to treatment group assignment conducted assessments by telephone at baseline and at 6, 12, 18, and 24 months. Primary Outcome The primary outcome measure was self-reported 7-day abstinence at 24 months, defined as not having smoked a cigarette during the previous 7 days. Although self-reported abstinence has been co

Predictors of quitting among African American light smokers enrolled in a randomized, placebo-controlled trial

AbstractOBJECTIVE: To examine the predictors of quitting among African American (AA) light smokers (<10 cigarettes per day) enrolled in a smoking cessation trial. METHODS: Baseline variables were analyzed as potential predictors from a 2 × 2 cessation trial in which participants were randomly assigned to 1 of 4 treatment groups: nicotine gum plus health education (HE) counseling, nicotine gum plus motivational interviewing (MI) counseling, placebo gum plus HE counseling, or placebo gum plus MI counseling. Chi-square tests, 2 sample t-tests, and multiple logistic regression analyses were used to identify predictors of cotinine (COT) verified abstinence at month 6. RESULTS: In the final regression model, HE rather than MI counseling (odds ratio [OR]=2.26%, 95% confidence interval [CI]=1.36 to 3.74), older age (OR=1.03%, 95% CI=1.01 to 1.06), and higher body mass index (OR=1.04%, 95% CI=1.01 to 1.07) significantly increased the likelihood of quitting, while female gender (OR=0.46%, 95% CI=0.28 to 0.76), ≤

A Review of Tobacco Use Treatments in U.S. Ethnic Minority Populations

1,800/month income (OR=0.60%, 95% CI=0.37 to 0.97), higher baseline COT (OR=0.948%, 95% CI=0.946 to 0.950), and not completing all counseling sessions (OR=0.48%, 95% CI=0.27 to 0.84) reduced the odds of quitting. CONCLUSIONS: Individual characteristics may decrease the likelihood of quitting; however, the provision of directive, advice-oriented counseling focused on the addictive nature of nicotine, health consequences of smoking, benefits of quitting, and development of a concrete quit plan may be an important and effective facilitator of quitting among AA light smokers.

CYP2B6 and Bupropion's Smoking‐Cessation Pharmacology: The Role of Hydroxybupropion

Background. Tobacco use is the leading preventable cause of disease and death in the United States. Among racial and ethnic minorities, disparities in tobacco use, knowledge of health risks and treatment resources, and access to and utilization of treatment contribute to a disproportionate disease burden from tobacco use. Furthermore, racial and ethnic minorities have been underrepresented within tobacco treatment studies. Purpose/Objective. This paper provides a review of published studies examining tobacco treatment interventions among ethnic and minority populations in the United States. Study Design/Methods. Literature searches were used to identify smoking cessation interventions involving racial/ethnic minority populations. Identified studies were published between 1985 and 2009 involving African-American, Latino, Native American, and Asian or Pacific Islander smokers. Studies included in the review (1) targeted one or more ethnic minority group or had at least 10% of study participants from ethnic minority groups and (2) reported abstinence outcomes. Results. Sixty-four studies were included in this review. Of studies meeting inclusion criteria, 28 included a primary focus on African-Americans, 10 focused on Latinos, 4 focused on Native Americans, and 3 focused on Asian-American smokers. An additional 19 studies reported samples including participants from more than one minority group. Sample inclusion criteria, intervention content and duration, follow-up, abstinence assessment, and limitations of these studies were reviewed. Conclusions. Individuals from racial and ethnic minority populations are interested in stopping smoking and willing to participate in treatment research. Variations in the content of treatment intervention and study design produced a range of abstinence outcomes across studies. Additional research is needed for all groups, including African-American smokers, and special attention is warranted for Latino, Native American, and Asian groups given the paucity of published studies. Although there were limited evaluations of pharmacotherapy, the existing data support use of pharmacotherapy in addition to counseling for enhancing abstinence outcomes. Further attention to level of individual smoking, variability in smoking patterns, and use of other tobacco products is needed, given known variation within and between racial and ethnic groups. Overall, findings are consistent with recommendations from the 2008 Clinical Practice Guidelines calling for increased research devoted to evaluating and enhancing tobacco use treatment interventions among racial and ethnic minority populations. (Am J Health Promot 2011;25[5 Supplement]:S11-S30.)

Baseline Characteristics and Recruitment Strategies in a Randomized Clinical Trial of African-American Light Smokers

Bupropion is indicated to promote smoking cessation. Animal studies suggest that the pharmacologic activity of bupropion can be mediated by its major metabolite, hydroxybupropion. We measured plasma bupropion and its metabolite levels in a double‐blind, placebo controlled, randomized smoking‐cessation trial. Among the treatment‐adherent individuals, higher hydroxybupropion concentrations (per μg/ml) resulted in better smoking‐cessation outcomes (week 3, 7, and 26 odds ratio (OR) = 2.82, 2.96, and 2.37, respectively, P = 0.005–0.040); this was not observed with bupropion levels (OR = 1.00–1.03, P = 0.59–0.90). Genetic variation in CYP2B6, the enzyme that metabolizes bupropion to hydroxybupropion, was identified as a significant source of variability in hydroxybupropion formation. Our data indicate that hydroxybupropion contributes to the pharmacologic effects of bupropion for smoking cessation, and that variability in response to bupropion treatment is related to variability in CYP2B6‐mediated hydroxybupropion formation. These findings suggest that dosing of bupropion to achieve a hydroxybupropion level of 0.7 μg/ml or increasing bupropion dose for CYP2B6 slow metabolizers could improve bupropions cessation outcomes.

Bupropion for Smoking Cessation in African American Light Smokers: A Randomized Controlled Trial

Purpose. This study describes the design, recruitment, and baseline data of the first smoking-cessation clinical trial for African-American light smokers, Kick It at Swope II (KIS-II). Design. KIS-II was a randomized trial testing the efficacy of nicotine gum (vs. placebo gum) in combination with counseling (motivational interviewing or health education). Setting. This study was conducted at an urban community-based clinic serving predominantly lower-income African-Americans. Subjects. African-Americans who smoked 1 to 10 cigarettes per day were eligible. Of 1933 individuals screened, 1012 (52%) were eligible and 755 (75%) were enrolled in the study. Measures. Baseline assessment included smoking history and psychometric measures. Analysis. The majority of participants were women (67%) with a mean age of 45.1 years (SD = 10.7). Participants smoked on average 7.6 cigarettes (SD = 3.21) per day, had a mean exhaled carbon monoxide level of 13.9 ppm (SD = 8.9) and a mean serum cotinine level of 244.2 ng/mL (SD = 154.4), and reported high levels of motivation and confidence to quit smoking. Conclusion. African-American light smokers were motivated to stop smoking and to enroll in a smoking-cessation program. Characteristics of our sample suggest African-American light smokers are an appropriate group for inclusion in smoking-cessation interventions.

National Cancer Institute Conference on Treating Tobacco Dependence at Cancer Centers

BACKGROUND Previous research demonstrated the efficacy of sustained release bupropion (bupropion SR) for smoking cessation in whites as well as moderate to heavy (≥10 cigarettes per day [CPD]) African American smokers. We evaluated whether bupropion SR was effective for smoking cessation among African American light smokers (≤10 CPD). METHODS A randomized, double-blind placebo-controlled trial was conducted from December 27, 2007, to May 13, 2010. All participants were African American light smokers (≤10 CPD), aged 18 years or older. Participants were randomly assigned to receive 300 mg bupropion SR (150 mg once daily for 3 days and then 150 mg twice daily) (n = 270 participants) or placebo (n = 270 participants) for 7 weeks, and up to six sessions of health education counseling. Serum cotinine was measured at baseline (week 0). The primary outcome was salivary cotinine-verified 7-day point prevalence smoking abstinence at week 26; a cut point of 15 ng/mL differentiated smokers from nonsmokers. Salivary cotinine-verified smoking abstinence at end of medication treatment at week 7 was also examined. Odds ratios (OR) for smoking abstinence and 95% confidence intervals (CIs) were calculated using logistic regression models. All statistical tests were two-sided. RESULTS Participants at baseline visit (week 0) smoked an average of 8.0 CPD and had a mean serum cotinine level of 275.8 ng/mL (SD = 155.8 ng/mL); most used menthol cigarettes (83.7%) and smoked within 30 minutes of waking (72.2%). After imputing those lost to follow-up as smokers, no statistically significant difference in long-term smoking abstinence rates at week 26 was observed between bupropion SR and placebo groups (13.3% vs 10.0%, OR = 1.39, 95% CI = 0.82 to 2.35, P = .23). Cotinine-verified smoking abstinence rate at end of medication week 7 was higher in the bupropion SR vs placebo group (23.7% vs 9.6%, OR = 2.92, 95% CI = 1.78 to 4.77, P < .001). CONCLUSIONS Bupropion SR was effective in promoting smoking cessation during the medication phase of treatment but showed no effect on long-term smoking cessation among African American light smokers. More research is needed to identify strategies for sustaining abstinence among African American light smokers.

Association of CHRNA5-A3-B4 SNP rs2036527 with smoking cessation therapy response in African-American smokers.

The National Cancer Institute cancer centers possess the credibility to help smokers quit. With the greater life expectancies forecast for patients with cancer, addressing smoking at cancer centers has taken on greater importance.

Patterns of smoking and methadone dose in drug treatment patients.

Associations between CHRNA5‐A3‐B4 variants and smoking behaviors exist; however, the association with smoking abstinence is less understood, particularly that among African Americans. In 1,295 African Americans enrolled in two clinical trials, we investigated the association between CHRNA5‐A3‐B4 and smoking abstinence. The rs2056527(A) allele was associated with lower abstinence with active pharmacotherapy (during treatment: odds ratio (OR) = 0.42, P < 0.001; end of treatment (EOT): OR = 0.55, P = 0.004), or with nicotine gum alone (during treatment: OR = 0.31, P < 0.001; EOT: OR = 0.51, P = 0.02), but not significantly with bupropion, although similar directions and magnitudes were observed (during treatment: OR = 0.54, P = 0.05; EOT: OR = 0.59, P = 0.08). In addition, the rs588765(T) allele was associated with abstinence with gum during treatment (OR = 2.31, P < 0.01). The SNP rs16969968 occurred at a low frequency and was not consistently associated with abstinence. CHRNA5‐A3‐B4 variants were not associated with tobacco consumption, and adjustments for smoking behaviors did not alter the associations with smoking abstinence. Together, our data suggest that among African Americans, CHRNA5‐A3‐B4 variants are not associated with baseline smoking but can influence smoking abstinence during active pharmacotherapy.