Self-help cessation programs for smokeless tobacco users: long-term follow-up of a randomized trial.

This paper presents long-term outcomes of the largest clinical trial of smokeless tobacco (SLT) cessation reported to date. SLT users in five northwestern states were recruited to call a toll-free number, and 1,069 users were randomized to one of two self-help conditions: either a manual-only condition or an assisted self-help condition, which included the manual, a targeted video, and two support phone calls. Significant between-group differences were not found for either the 12- or 18-month point-prevalence measure of abstinence from either SLT only or all tobacco products using outcomes based on either the responder or intention-to-treat outcomes. However, using a repeated point-prevalence measure across all three assessment points, we found that significantly more assisted self-help participants reported abstinence, compared with manual-only participants. Compared with manual-only participants, those in the assisted self-help condition were significantly more likely to use recommended cessation techniques. Results demonstrate that low-cost, minimal interventions delivered by mail and phone can help a sizable proportion of individuals quit using SLT.     

Hypnosis for smoking cessation: a randomized trial

The purpose of this study was to determine whether hypnosis would be more effective in helping smokers quit than standard behavioral counseling when both interventions are combined with nicotine patches (NP). A total of 286 current smokers were enrolled in a randomized controlled smoking cessation trial at the San Francisco Veterans Affairs Medical Center. Participants in both treatment conditions were seen for two 60-min sessions, and received three follow-up phone calls and 2 months of NP. At 6 months, 29% of the hypnosis group reported 7-day point-prevalence abstinence compared with 23% of the behavioral counseling group (relative risk [RR] = 1.27; 95% confidence interval, CI 0.84-1.92). Based on biochemical or proxy confirmation, 26% of the participants in the hypnosis group were abstinent at 6 months compared with 18% of the behavioral group (RR = 1.44; 95% CI 0.91-2.30). At 12 months, the self-reported 7-day point-prevalence quit rate was 24% for the hypnosis group and 16% for the behavioral group (RR = 1.47; 95% CI 0.90-2.40). Based on biochemical or proxy confirmation, 20% of the participants in the hypnosis group were abstinent at 12 months compared with 14% of the behavioral group (RR = 1.40; 95% CI 0.81-2.42). Among participants with a history of depression, hypnosis yielded significantly higher validated point-prevalence quit rates at 6 and 12 months than standard treatment. It was concluded that hypnosis combined with NP compares favorably with standard behavioral counseling in generating long-term quit rates.     

Smoking cessation in homeless populations: a pilot clinical trial.

This study, which tested two motivational interviewing treatment approaches, assessed the feasibility of conducting a community-based smoking cessation intervention among homeless smokers. Participants (N = 46) were recruited from multiple facilities in the Kansas City area and were randomized to two counseling conditions in which they received five individual motivational interviewing sessions, six group meetings, and their choice of 8 weeks of 21-mg nicotine patch or 4-mg nicotine lozenge. The two counseling conditions consisted of motivational interviewing targeted either to smoking behaviors exclusively (smoking only) or to smoking and other addictions or life events that could affect ability to quit (smoking plus). Group meetings were designed to provide educational information and social support. Measures of feasibility assessed included the proportion of participants who returned for randomization among those eligible, adherence to prescribed nicotine replacement therapies, retention rates at the week 26 final study visit, and biochemically verified 7-day abstinence at week 26. Most participants (69.6%) chose nicotine patches, and 32% of those participants reported using at least four patches per week. Carbon monoxide verified 7-day abstinence rates in the smoking-only and smoking-plus groups were 13.04% and 17.39% (ns), respectively, at week 8 and 8.70% and 17.39% (ns), respectively, at week 26. Participants who used at least four patches per week were more likely to have quit at 8 weeks than were those who used fewer patches (33.3% vs. 10.5%, p = .30). Results support the feasibility of conducting a smoking cessation intervention among homeless smokers. Findings also show promising effects for nicotine replacement therapy and counseling in this population. Developing programs to improve smoking cessation outcomes in underserved populations is an essential step toward achieving national health objectives and for ultimately reducing tobacco-related health disparities.     

Smoking reduction fails to improve clinical and biological markers of cardiac disease: a randomized controlled trial.

Cigarette reduction has been proposed as a treatment goal for smokers who are not interested in stopping completely. This randomized controlled trial was designed to determine the effect of a smoking reduction intervention on smoking behavior, symptoms of heart disease, and biomarkers of tobacco exposure. It included 152 patients with heart disease who did not intend to stop smoking in the next 30 days. Participants were randomly assigned to smoking reduction (SR) or usual care (UC). SR subjects received counseling and nicotine replacement therapy to encourage > or =50% reduction in cigarettes per day (CPD). They were followed at 1, 3, 6, 12 and 18 months to assess smoking, heart disease symptoms, quality of life and nicotine, cotinine, carbon monoxide (CO), white blood cell (WBC) count, fibrinogen, hs-C-reactive protein (hs-CRP), F2-isoprostane, 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol and its glucuronides (total NNAL), and 1-hydroxypyrene (1-HOP). At 6 months SR participants reduced by 10.9 CPD, compared with 7.4 CPD in UC (difference NS). At 18 months, 9/78 SR vs. 9/74 UC participants quit smoking. There were no significant differences between treatment groups in angina, quality of life or adverse events, nicotine, cotinine, CO, WBC count, fibrinogen, hs-CRP, F2-isoprostane, total NNAL or 1-HOP levels at any time point. To determine if smoking reduction, regardless of treatment condition, was associated with improved outcomes, we compared all subjects at 6 months to baseline (mean reduction in CPD from 27.4 to 18.1, p<.01). There were no significant changes in outcome variables except CO, which decreased by 5.5 ppm (p<.01). There were also no significant improvements considering only subjects who reduced by > or =50%, or those who had no history of reduction prior to enrollment in the study. The SR intervention did not significantly reduce CPD or toxin exposure, or improve smoking cessation or clinical outcomes compared to UC. These results emphasize the importance of abstinence for smokers with heart disease to minimize health risks from tobacco.     

Smoking cessation with smokeless tobacco and group therapy: an open, randomized, controlled trial

Smokeless tobacco might be effective as an adjunct for smoking cessation. We evaluated the efficacy of smokeless tobacco and group support for smoking cessation in an open, randomized study that compared smokeless tobacco plus group support versus group support only. The study enrolled 263 healthy smokers (M (age) = 49 years) who smoked a mean of 24 cigarettes/day, with a mean of 31 pack-years. Smokeless tobacco was provided for 7 weeks (or up to 12), combined with eight group support visits provided by nurses. The control group received group support only. Smoking cessation rates were statistically significantly better in the smokeless tobacco group than in the control group during the first 7 weeks. Point-prevalence abstinence rates at 7 weeks were 36.4% versus 20.8% (OR = 2.52, p = .001), respectively; and continuous abstinence rates from weeks 4 to 7 were 31.5% versus 19.2% (OR = 1.94, p = .023), respectively. The primary outcomes (i.e., 6-month point prevalence) were 23.1% versus 20.8%, respectively (OR = 1.31, ns). Smokeless tobacco was relatively well tolerated, although 15 subjects (11.2%) stopped use due to adverse events. A total of 25 subjects (17.5 %) were still using smokeless tobacco after 6 months. This trial demonstrated short-term efficacy of smokeless tobacco in combination with group support for smoking cessation but no long-term efficacy.     

A randomized controlled clinical trial of bupropion SR and individual smoking cessation counseling.

Efficacy of bupropion SR and individual counseling as smoking cessation treatments was assessed in a randomized, placebo-controlled clinical trial among adult daily smokers. Bupropion SR treatment and counseling were fully crossed in this factorial design so that the efficacy of each treatment and the combination could be estimated, relative to a placebo medication and assessment control condition. Intent-to-treat analyses indicated that bupropion SR increased abstinence rates at the end of treatment, relative to the placebo medication conditions, for both biochemically confirmed 7-day point-prevalence abstinence (OR = 1.97, 95% CI 1.04-3.72) and self-reported prolonged abstinence (OR = 2.90, 95% CI 1.66-5.06). Bupropion SR treatment also improved latency to lapse and relapse and improved the latency between lapse and relapse in survival analyses. Medication effects were more modest for both 12-month point-prevalence abstinence (OR = 1.47, 95% CI 0.74-2.92) and prolonged abstinence (OR = 1.34, 95% CI 0.66-2.72). Counseling was not associated with increases in the likelihood of abstinence at any time point (odds ratios ranged from 0.80 to 1.16 across abstinence outcomes in the full intent-to-treat sample). Counseling and medication did not significantly interact at any time point, and adding counseling did not improve end-of-treatment point-prevalence abstinence (OR = 1.17, 95% CI 0.68-2.03) or prolonged abstinence (OR = 1.26, 95% CI 0.75-2.12) substantially when offered in conjunction with active medication.     

Smoking cessation pharmacotherapy preferences in rural primary care.

Pharmacotherapy is a critical adjunct to smoking cessation therapy. Little is known about relative preferences for these agents among smokers in primary care settings. In the context of a population-based clinical trial, we identified 750 smokers in primary care practices and independent of their readiness to quit offered them a free treatment course of either bupropion or transdermal nicotine replacement (TNR). Smokers opting for pharmacotherapy completed standardized contraindication screens that were reviewed by the patient's primary care physician. Most participants (67%) requested pharmacotherapy. Use of pharmacotherapy was positively associated with higher nicotine dependence and readiness to quit. Of the smokers requesting pharmacotherapy, 51% requested bupropion and 49% requested TNR. Choice of bupropion was related to no history of heart disease and no previous use of bupropion. Although potential contraindications to treatments were identified for 21.7% of bupropion and 6.6% of TNR recipients, physicians rarely felt that these potential contraindications precluded the use of these agents. When cost is removed as a barrier, a large proportion of rural smokers are eager to use smoking cessation pharmacotherapy, especially agents that they have not tried before. Although some comorbid conditions and concurrent drug therapies were considered contraindications, particularly to bupropion, physicians rarely considered these clinically significant risks enough to deny pharmacotherapy.     

Computer-tailored smoking cessation intervention in a general population setting in Germany: outcome of a randomized controlled trial.

This study reports the outcome of a randomized controlled trial testing a computer-tailored smoking cessation intervention based on the transtheoretical model in a general population setting in Germany. Participants of the smoking intervention study were recruited from an existing general population health examination survey in a university hospital. The sample consisted of 611 current and former smokers at baseline, and of 485 participants in the core group of baseline daily cigarette smokers. Follow-ups were conducted 6, 12, 18, and 24 months after baseline. The intervention was designed for both current and former smokers, involved up to three individualized feedback letters, and was created using expert-system technology. Based on 7-day point-prevalence abstinence and 6-month prolonged abstinence as the outcome measures, the study identified no significant differences between the intervention and control groups. Modeling the full longitudinal data in generalized estimation equation analyses, using different nonresponse procedures, and adjusting for covariates did not alter the results. We conclude that the computer-tailored transtheoretical model-based smoking cessation intervention, as delivered in this study and in this special setting, was ineffective.     

Anticipating clinical integration of genetically tailored tobacco dependence treatment: perspectives of primary care physicians.

Emerging research will likely make it possible to tailor pharmacological treatment for individuals with tobacco dependence by genotype. This study explored primary care physicians' attitudes about the strengths of and barriers to using genetic testing to match patients to optimal nicotine replacement therapy. Four focus groups (n=27) were conducted, and data were analyzed using thematic content analysis. Physicians reported how likely they would be to offer patients a genetic test to tailor smoking treatment in response to three different scenarios that described characteristics of the genetic test based on published research. Respondents were on average 36 years of age; 59% were male and 67% were white. Physicians believed genetically tailored treatment may offer new hope to smokers trying to quit, yet they also noted several potential barriers to clinical integration. Barriers included erroneous assumptions by patients regarding the meaning of genetic test results, possible misinterpretation of information regarding racial differences in the prevalence of certain risk alleles, and potential discrimination against patients undergoing testing. Concerns increased dramatically when physicians were told that the same genotypes that would be identified to tailor smoking treatment also have been associated with increased risk of becoming addicted to nicotine, as well as other addictions and psychiatric disorders. Physicians were interested in the possibility of realizing improved smoking cessation outcomes through pharmacogenetic developments, but they also raised many concerns. Primary care physicians will need additional educational inputs and system support prior to integrating genetic testing for a common trait into their routine clinical practice.     

The influence of depressive symptoms on smoking cessation among African Americans in a randomized trial of bupropion.

The influence of depressive symptoms on smoking cessation was examined among 600 African American smokers who participated in a randomized, placebo-controlled trial of sustained-release bupropion hydrochloride. Depressive symptoms were assessed at baseline, at week 6 (end of treatment), and at 6-month follow-up. The study examined three separate questions: (a) Whether depressive symptom levels were related to smoking cessation, (b) whether bupropion was more effective for smokers who had higher depressive symptoms at baseline (i.e., a moderator model), and (c) whether changes in depressive symptoms would account for the efficacy of bupropion for smoking cessation (i.e., a mediator model). Depressive symptoms at baseline were not predictive of cessation; however, increases in depressive symptoms from baseline predicted reduced cessation at the end of treatment, and higher depressive symptoms at week 6 and month 6 were associated with a reduced likelihood of smoking cessation at those time points. The moderator model was not supported, but the mediation analyses indicated that alleviation of depressive symptoms partly accounted for bupropion-assisted smoking cessation at end of treatment. Results extend prior findings to African American smokers and suggest that clinicians consider increases in depressive symptoms after quitting rather than baseline depressive symptoms in predicting risk of treatment failure. Results also suggest that even though bupropion may facilitate cessation in part by reducing depressive symptoms, it appears to be no more effective for more depressed smokers, and that mechanisms other than depressive symptom alleviation account for most of its efficacy.     

Recurrent event analysis of lapse and recovery in a smoking cessation clinical trial using bupropion.

We report a reanalysis of data from a prior study describing the event history of quitting smoking aided by bupropion, using recurrent-event models to determine the effect of the drug on occurrence of lapses and recoveries from lapse (resumption of abstinence). Data were collected on 1,070 subjects across two similar double-blind randomized clinical trials of bupropion versus placebo and fitted with separate Cox regression models for lapse and recovery. Analyses were split using discrete time-varying covariates between the treatment (weeks 1-10) and follow-up phases (end of treatment to 12 months). Bupropion was associated with slower lapse during treatment for both sexes, and being female was associated with faster lapse across both phases. Drug did not affect time to recovery for males but was associated with faster recovery among females, allowing women to recover as quickly as men. High levels of nicotine dependence did not affect time to lapse but were associated with slower recovery from lapse across treatment and follow-up phases. During the treatment phase, higher levels of baseline depression symptoms had no effect on time to lapse but were associated with slower recovery from lapse. Results highlight the asymmetry in factors preventing lapse versus promoting recovery. Specifically, dependence, depression symptoms, and a sex x drug interaction were found to affect recovery but not lapse. Further research disentangling lapse and recovery events from summary abstinence measures is needed to help us develop interventions that take advantage of bupropion at its best and that compensate where it is weak.     

Evaluating the effectiveness of a single telephone contact as an adjunct to a self-help intervention for smoking cessation in a randomized controlled trial.

This study evaluated the effects of including a single brief prequit telephone counseling session in a self-help program for smoking cessation conducted through the mail, by comparison with the effects of the self-help program alone. Volunteer participants from northwestern Spain (N = 228) were randomly assigned to one of two groups: (a) the self-help-only group (n = 110, mean age = 37.4 years, pretreatment cigarette consumption = 26.5 cigarettes/day) or (b) the telephone-support group (n = 118, mean age = 36.8 years, pretreatment cigarette consumption = 27.7 cigarettes/day). Using a conservative data analysis method (missing data considered as treatment failures), we found that the point-prevalence abstinence rate was significantly higher in the telephone-support group than in the self-help-only group at the end of treatment (44.9% vs. 21.8%) and at the 3-month follow-up (39.0% vs. 26.4%). Likewise, sustained abstinence was significantly higher in the telephone-support group at the 3-month follow-up (33.9% vs. 13.6%), the 6-month follow-up (25.4% vs. 12.7%), and the 12-month follow-up (21.2% vs. 9.1%). The results of this randomized controlled trial indicate that both treatments are an effective aid for smoking cessation, and that a single brief telephone call before the quit date is a low-cost and effective procedure for improving abstinence rates in a mailed self-help program.     

Spirometry as a motivational tool to improve smoking cessation rates: a systematic review of the literature.

Obtaining spirometric testing and providing those results to individuals who smoke has been advocated as a motivational tool to improve smoking cessation. However, its effectiveness is not known. We conducted a systematic review to determine if this approach improves rates of smoking cessation. Data sources included MEDLINE (1966 to October 2005), the Cochrane Library, and experts in the field. Eligible randomized controlled trials (RCTs) enrolled at least 25 smokers per arm, evaluated spirometry with associated counseling or in combination with other treatments, followed subjects at least 6 months, and provided smoking abstinence rates. Results from nonrandomized studies also were summarized. The primary outcome was patient-reported long-term (at least 6 months) sustained abstinence with biological validation. Additional outcomes included self-reported abstinence and point-prevalence abstinence. Seven RCTs (N = 6,052 subjects) met eligibility criteria. Follow-up duration ranged from 9 to 36 months. In six trials, the intervention group received concomitant treatments previously demonstrated to increase cessation independently. The range of abstinence was 3%-14% for control subjects and 7%-39% among intervention groups, statistically significantly in favor of intervention in four studies. The only RCT that assessed the independent contribution of spirometry in combination with counseling demonstrated a nonsignificant 1% improvement in patient-reported point-prevalence abstinence at 12 months in the group that received spirometry plus counseling versus counseling alone (6.5% versus 5.5%). Findings from observational studies were mixed, and the lack of controls makes interpretation problematic. Available evidence is insufficient to determine whether obtaining spirometric values and providing that information to patients improves smoking cessation compared with other smoking cessation methods. Spirometric values are of limited benefit as a predictor of smoking cessation or as a tool to "customize" smoking cessation strategies.