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.     

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.     

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.     

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.     

Effectiveness of biomedical risk assessment as an aid for smoking cessation: a systematic review

Objective

To determine the efficacy of biomedical risk assessment (eg, exhaled carbon monoxide (CO), or genetic susceptibility to lung cancer) as an aid for smoking cessation.

Data sources

Cochrane Tobacco Addiction Group Specialized Register, Cochrane Central Register of Controlled Trials, Medline (1966–2004) and EMBASE (1980–2004).

Study selection

Randomised controlled smoking cessation interventions using biomedical tests with at least 6 months follow‐up.

Data extraction

Two reviewers independently screened all search results (titles and abstracts) for possible inclusion. Each reviewer then extracted data from the selected studies, and assessed their methodological quality based on the CONSORT (Consolidated Standards of Reporting Trials) statement criteria.

Data synthesis

Of 4049 retrieved references, eight trials were retained for data extraction and analysis. Three trials isolated the effect of exhaled CO on smoking cessation rates resulting in the following ORs and 95% CIs: 0.73 (0.38 to 1.39), 0.93 (0.62 to 1.41) and 1.18 (0.84 to 1.64). Measurement of exhaled CO and spirometry were used together in three trials, resulting in the following ORs (95% CI): 0.60 (0.25 to 1.46), 2.45 (0.73 to 8.25) and 3.50 (0.88 to 13.92). Spirometry results alone were used in one other trial with an OR (95% CI) of 1.21 (0.60 to 2.42). Ultrasonography of carotid and femoral arteries performed on light smokers gave an OR (95% CI) of 3.15 (1.06 to 9.31).

Conclusions

Scarcity and limited quality of the current evidence does not support the hypothesis that biomedical risk assessment increases smoking cessation as compared with the standard treatment.Despite increasing scientific knowledge about health hazards due to cigarette consumption, there is, in many countries, an increase in the prevalence of smoking among young people.^1,2 The gap between knowledge and smoking cessation has been attributed, partly, to smokers'' underestimation of their personal risks of smoking‐related illness.^3,4A possible strategy for increasing quit rates might be to provide a personalised feedback on the physical effects of smoking by physiological measurements. We can distinguish three different types of feedback: the first one explores biomarkers of smoking exposure (cotinine and carbon monoxide (CO)); the second one gives information on smoking‐related disease risk (eg, lung cancer susceptibility according to CYP2D6 genotyping)⁵; and the third one depicts smoking‐related harm (eg, atherosclerotic plaque and impaired lung functions).⁶ The rationale for such interventions is to promote risk awareness and motivation to accelerate changes in smoking‐behaviour.^7,8Individual studies have provided conflicting data on the effect of physiological feedback.^{9,10,11,12,13,14,15,16,17} We aimed to review the data on smoking cessation rates from controlled trials using feedback on the physiological effects of smoking or on the genetic susceptibility to smoking‐related diseases. This article is a shortened version of our Cochrane review.¹⁸     

Gabapentin for smoking cessation: a preliminary investigation of efficacy.

Gabapentin affects the glutamate and gamma amino butyric acid (GABA) neurotransmitters through which it may facilitate smoking abstinence. To obtain preliminary estimates of efficacy of gabapentin for smoking cessation, we conducted a single-arm, open-label study of gabapentin, 1,800-mg/day administered in three equal divided doses for 8 weeks. A total of 50 adult smokers were enrolled. All participants received a brief behavioral intervention at each medication visit. A total of 37 participants completed all follow-up assessments. At end-of-treatment the biochemically confirmed point-prevalence and prolonged smoking abstinence rates were 28% (95% CI=16%-42%) and 24% (95% CI=13%-38%), respectively. At 6 months, the biochemically confirmed point-prevalence and prolonged smoking abstinence rates were 20% (95% CI=10%-34%) and 16% (95% CI=7%-29%), respectively. Among subjects who continued to smoke and completed the follow-up assessments, the reported number of cigarettes smoked per day (mean+/-standard deviation) was significantly less than at baseline: -10.0+/-8.2 (p<.001). Adverse effects were minor and well tolerated. Our results suggest that gabapentin may increase smoking abstinence. An adequately powered randomized clinical trial assessing different doses of this drug against a placebo would be the reasonable next step.     

Variations in treatment benefits influence smoking cessation: results of a randomised controlled trial

OBJECTIVE: To assess the impact and costs of coverage for tobacco dependence treatment benefits with no patient cost sharing for smokers with employer sponsored coverage in two large independent practice association (IPA) model health maintenance organisations (HMOs) in California, USA. METHODS: A randomised experimental design was used. 1204 eligible smokers were randomly assigned either to the control group, which received a self-help kit (video and pamphlet), or to the treatment group, which received the self-help kit and fully covered benefits for over the counter (OTC) nicotine replacement therapy (NRT) gum and patch, and participation in a group behavioural cessation programme with no patient cost sharing. RESULTS: The quit rates after one year of follow up were 18% in the treatment group and 13% in the control group (adjusted odd ratio (OR) 1.6, 95% confidence interval (CI) 1.1 to 2.4), controlling for health plan, sociodemographics, baseline smoking characteristics, and use of bupropion. Rates of quit attempts (adjusted OR 1.4, 95% CI 1.1 to 1.8) and use of nicotine gum or patch (adjusted OR 2.3, 95% CI 1.6 to 3.2) were also higher in the treatment group. The annual cost of the benefit per user who quit ranged from $1495 to $965 or from $0.73 to $0.47 per HMO member per month. CONCLUSIONS: Full coverage of a tobacco dependence treatment benefit implemented in two IPA model HMOs in California has been shown to be an effective and relatively low cost strategy for significantly increasing quit rates, quit attempts, and use of nicotine gum and patch in adult smokers.     

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.     

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.     

Bupropion and cognitive-behavioral therapy for smoking cessation in women.

Gender data for bupropion suggest that it may be a particularly effective smoking cessation medication for women. It is not known whether the efficacy of this pharmacotherapy differs as a function of the psychotherapy with which it is administered. This study used a two level factorial design to examine the independent and interactive effects of medication (bupropion 300 mg/day vs. placebo) and psychotherapy (cognitive-behavioral therapy [CBT] vs. supportive therapy [ST]). In addition to testing the hypothesis that bupropion with CBT would be most effective of all the treatments, we examined medication compliance and its role in the efficacy of bupropion. Participants were 154 women, aged at least 30 years and smoking more than 10 cigarettes/day. Compliance with study medication was assessed using Medication Event Monitoring Systems (MEMS) over 7 weeks of treatment. Psychological interventions were delivered in 60-min weekly group sessions. Longitudinal analysis of abstinence outcomes from end of treatment (EOT) through 12 months after treatment revealed a significant interaction of medication and therapy. Higher abstinence rates at EOT and 3-, 6-, 9-, and 12-month follow-ups were observed when bupropion was delivered concurrently with CBT (44%, 24%, 30%, 23%, 17%) rather than with ST (18%, 1%, 8%, 5%, 2%). The bupropion-CBT combination, however, was not clearly superior to placebo, regardless of therapy assignment. Higher rates of medication compliance were positively predictive of abstinence, and this effect was most evident in the placebo condition. Findings provide only modest support for CBT as the preferred type of intensive therapy in conjunction with bupropion in women.     

Pharmacogenetic clinical trial of sustained-release bupropion for smoking cessation.

This randomized, double-blinded, placebo-controlled trial examined genetic influences on treatment response to sustained-release bupropion for smoking cessation. Smokers of European ancestry (N = 291), who were randomized to receive bupropion or placebo (12 weeks) plus counseling, were genotyped for the dopamine D2 receptor (DRD2-Taq1A), dopamine transporter (SLC6A3 3' VNTR), and cytochrome P450 2B6 (CYP2B6 1459 CT) polymorphisms. Main outcome measures were cotinine-verified point prevalence of abstinence at end of treatment and at 2-, 6-, and 12-month follow-ups post quit date. Using generalized estimating equations, we found that bupropion, compared with placebo, was associated with significantly greater odds of abstinence at all time points (all p values<.01). We found a significant DRD2 x bupropion interaction (B = 1.49, SE = 0.59, p = .012) [corrected] and a three-way DRD2 x bupropion x craving interaction on 6-month smoking cessation outcomes (B = -0.45, SE = 0.22, p = .038), such that smokers with the A2/A2 genotype demonstrated the greatest craving reduction and the highest abstinence rates with bupropion. Furthermore, there was a significant DRD2 x CYP2B6 interaction (B = 1.43, SE = 0.56, p = .01), such that individuals with the DRD2-Taq1 A2/A2 genotype demonstrated a higher odds of abstinence only if they possessed the CYP2B6 1459 T/T or C/T genotype. Because the sample size of this study was modest for pharmacogenetic investigations, the results should be interpreted with caution. Although these results require replication, the data suggest preliminarily that the DRD2-Taq1A polymorphism may influence treatment response to bupropion for smoking cessation and, further, that exploration of gene x gene and gene x craving interactions in future, larger studies may provide mechanistic insights into the complex pharmacodynamics of bupropion.     

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.     

Nortriptyline for smoking cessation: a review.

This article reviews the efficacy of nortriptyline for smoking cessation based on a meta-analysis of the Cochrane Library. Six placebo-controlled trials have shown nortriptyline (75-100 mg) doubles quit rates (OR = 2.1). Between 4% and 12% of smokers dropped out because of adverse events, but no serious adverse events occurred. The efficacy of nortriptyline did not appear to be related to its antidepressant actions. Nortriptyline is an efficacious aid to smoking cessation with a magnitude of effect similar to that for bupropion and nicotine replacement therapies. Whether nortriptyline produces serious side effects at these doses in healthy, nondepressed smokers remains unclear because it has been tested in only 500 smokers. The finding that nortriptyline and bupropion are effective for smoking cessation but that selective serotonin-reuptake inhibitors are not suggests that dopaminergic or adrenergic, but not serotonergic, activity is important for cessation efficacy. Until further studies can verify a low incidence of significant adverse events, nortriptyline should be a second-line treatment for smoking cessation.     

Training pharmacists and pharmacy assistants in the stage-of-change model of smoking cessation: a randomised controlled trial in Scotland

OBJECTIVE—To evaluate a training workshop for community pharmacy personnel to improve their counselling in smoking cessation based on the stage-of-change model.
DESIGN—A randomised controlled trial of community pharmacies and pharmacy customers.
SETTING—All 76 non-city community pharmacies registered in Grampian, Scotland, were invited to participate. Sixty-two pharmacies (82%) were recruited.
SUBJECTS—All the intervention pharmacy personnel were invited to attend the training; 40 pharmacists and 54 assistants attended. A total of 492 customers who smoked (224 intervention, 268 controls) were recruited during the 12-month recruitment period (overall recruitment rate 63%).
MAIN OUTCOME MEASURES—The perceptions of customers and pharmacy personnel of the pharmacy support and self-reported smoking cessation rates for the two groups of customers at one, four, and nine months.
RESULTS—The intervention customer respondents were significantly more likely to have discussed stopping smoking with pharmacy personnel, 85% (113) compared with 62% (99) of the controls (p<0.001). The former also rated their discussion more highly; 34% (45) of the intervention customers compared with 16% (25) of the controls rated it as "very useful" (p = 0.048). Assuming non-responders had lapsed, one-month point prevalence of abstinence was claimed by 30% of intervention customers and 24% of controls (p = 0.12); four months' continuous abstinence was claimed by 16% of intervention customers and 11% of controls (p = 0.094); and nine months' continuous abstinence was claimed by 12% of intervention customers and 7% of controls (p = 0.089). These trends in outcome were not affected by potential confounders (sex, age, socioeconomic status, nicotine dependence, and type of nicotine replacement product used) or adjustment for clustering.
CONCLUSIONS—The intervention was associated with increased and more highly rated counselling, and a trend toward higher smoking cessation rates, indicating that community pharmacy personnel have the potential to make a significant contribution to national smoking cessation targets.


Keywords: community pharmacy; health education; smoking cessation     

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.     

Randomized trial of a smoking cessation intervention in hospitalized patients

A hospitalization is a time when perceived vulnerability to dangers from smoking and quitting motivation may be at their peak. Aim was to determine whether a smoking cessation intervention of moderate intensity would increase the smoking cessation rate in hospitalized smokers. Design was randomized trial, conducted in a university-affiliated cardio-pulmonary tertiary care center. Participants were hospitalized smokers aged < or =70 years. Intervention was a smoking cessation intervention consisting of education and psychological support, with or without pharmacological therapy, associated with follow-up phone calls. Patients assigned to the control group received usual care. Measurement was point prevalence cessation rate at 1-year follow-up. A total of 468 patients were screened; 196 were randomized. Although the smoking cessation rates at 12-month follow-up were higher than expected, we found no significant difference between the study groups (intervention: 30.3%; control: 27.8%). Similar results were obtained in patients whose smoking status was validated by urinary cotinine assay. Length of stay and dependence to nicotine were the only significant predictors of smoking cessation. A smoking cessation intervention of moderate intensity delivered in a tertiary cardio-pulmonary center did not increase the smoking cessation rate at 1-year follow-up. The results of this trial should not divert those who deliver care to inpatients from delivering a brief smoking cessation intervention.     

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+.