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.     

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.     

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.     

A randomized trial of nicotine replacement therapy in combination with reduced-nicotine cigarettes for smoking cessation

A randomized double-blind, active controlled, parallel group, multi-center phase II clinical trial was conducted to evaluate the efficacy of reduced-nicotine cigarettes as a novel smoking cessation treatment (under Investigational Device Exemption 69,185). The concept for a reduced-nicotine cigarette designed to progressively wean smokers from the smoking habit is based on research demonstrating that successful smoking cessation is not only dependent on withdrawal of nicotine, but also on weaning from the habitual sensory and behavioral reinforcement of smoking. Treatment consisted of Quest brand of cigarettes (Quest 1, 2, and 3), which respectively deliver 0.59+/-0.06, 0.3+/-0.05, and less than 0.05 mg nicotine, either alone or in combination with nicotine replacement therapy (NRT). The primary endpoint was 4 weeks of continuous abstinence (Weeks 7-10), with additional follow-up at 3 and 6 months. Adult men and women smokers (N = 346), motivated to quit, were randomized to one of three treatment groups: Quest plus NRT (NRT pretreatment 2 weeks before, and NRT after the quit date), Quest plus placebo patch, or active control plus NRT (conventional cigarette, followed by NRT after quit date). Results showed that Quest plus NRT was more effective than active control plus NRT in achieving 4 weeks of continuous abstinence (32.8% vs. 21.9%). Quest plus placebo patch yielded an abstinence rate similar to that of the active control plus NRT (16.4% vs. 21.9%). No serious adverse events were attributable to the investigational product. Quest plus NRT offers promise as a new smoking cessation treatment.     

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.     

Provider feedback to improve 5A's tobacco cessation in primary care: a cluster randomized clinical trial.

The electronic health record (EHR) may be an effective tool to help clinicians address tobacco use more consistently. To evaluate the impact of EHR-generated practice feedback on rates of referral to a state-level tobacco quitline, we conducted a cluster randomized clinical trial (feedback versus no feedback) within 19 primary care clinics in Oregon. Intervention clinics received provider-specific monthly feedback reports generated from EHR data. The reports rated provider performance in asking, advising, assessing, and assisting with tobacco cessation compared with a clinic average and an achievable benchmark of care. During 12 months of follow-up, EHR-documented rates of advising, assessing, and assisting were significantly improved in the intervention clinics compared with the control clinics (p<.001). A higher case-mix index and presence of a clinic champion were associated with higher rates of referral to a state-level quitline. EHR-generated provider feedback improved documentation of assistance with tobacco cessation. Connecting physician offices to a state-level quitline was feasible and well accepted.     

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.     

Effects of greens+: a randomized, controlled trial.

Greens+ is a popular natural health product marketed as energy-enhancing; however, no objective data substantiate this claim. The study objective was to determine if ingestion of greens+ 1. increases vitality, energy, and perception of well-being; 2. increases overall mental health and general health, and 3. decreases the incidence of colds and flus in an otherwise healthy female population. A total of 105 women were enrolled in this 12-week, randomized, double-blind, placebo-controlled clinical trial; 63 (60%) completed the treatment protocol. Both treatment and placebo groups showed a significant time trend effect, scoring better on all outcome measures as the trial progressed. Compared with the placebo group, the greens+ group scored marginally higher on vitality, the primary outcome measure (p=0.055), and significantly higher on energy (a secondary outcome measure, p=0.018). Findings were based on repeated measures analysis of variance; baseline scores were used as covariates. Although a trend toward greater improvement in the greens+ group was noted in the other secondary outcome measures, this trend did not reach statistical significance. Overall, our findings were positive but not conclusive that greens+ increases vitality and energy. These results provide justification for further study of the effects of greens+.     

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.     

Nicotine replacement therapy, professional therapy, snuff use and tobacco smoking: a study of smoking cessation strategies in southern Sweden

Objectives

The strategies used to support smoking cessation among quitters were investigated according to year of smoking cessation and sociodemographic characteristics.

Methods

The 2004 public health survey in Skåne, Sweden, is a cross‐sectional study. A total of 27 757 people aged 18–80 answered a postal questionnaire. The participation rate was 59%. Different strategies to support smoking cessation—that is, no therapy, nicotine replacement (NRT), professional therapy and snus (snuff) use, were investigated among quitters according to year of smoking cessation, and demographic and socioeconomic characteristics.

Results

14.9% of the men and 18.1% of the women were daily smokers. The prevalence of daily snus use was 19.5% among men but only 2.3% among women. Stratifying the data according to year of smoking cessation (1938–2004) revealed a significant increase in active smoking cessation strategies such as NRT, professional therapy and snus use. NRT was more common among women (23.6%) than men (14.8%) among smokers who quit in 2000–4, but snus use was more common among men (30.4% versus 8.7%). No replacement or other therapy at all was significantly more common among women (63.6%) than men (52.1%). People aged 35–80 years used more nicotine replacement than people aged 18–34, while men aged 18–34 used snus to quit smoking significantly more than men aged 55–80.

Conclusions

Snus is used commonly among men as a support for smoking cessation in Sweden. Women use pharmacological NRT to a greater extent, but this can probably not compensate for the much higher extent of snuff use as a cessation strategy among men.     

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.     

Smoking cessation treatment on the Internet: content, quality, and usability.

The explosive growth in access to the Internet suggests that the Internet may be a viable channel through which we can reach and treat the large population of smokers who are unlikely to use other modes of intervention. We applied national guidelines from the U.S. Public Health Service to assess the quality of interventions for smoking cessation that are available on the Internet. The Public Health Service guidelines were codified into two instruments to record and to rate quality of the intervention contents. Usability guidelines established by the National Cancer Institute were used to develop an instrument to assess Web site usability. Of the 202 Web sites identified in searches, 77% did not provide direct intervention over the Internet and were excluded from analyses. A total of 46 Web sites were included in our review. Usability assessments showed mixed results. Web sites were visually well organized and used consistent graphical design; however, reading difficulty averaged above the 8th-grade level. Over 80% of Web sites provided no coverage of one or more of the key components of tobacco treatment recommended in the guidelines. Ironically, areas receiving the least coverage were those most amenable to the interactive capabilities of the Internet, such as providing tailored, personalized advice to quit and arranging follow-up contact. Smokers seeking quality tobacco dependence treatment on the Internet may have difficulty distinguishing among the numerous Web sites available. Web sites that provide direct treatment often fail to fully implement treatment guidelines and do not take full advantage of the interactive and tailoring capabilities of the Internet.