Jordan tobacco dependence treatment guidelines: rationale and development.

Jordan, a high tobacco-burden country, has been working to expand its tobacco dependence treatment services and has completed development of its first customized treatment guidelines. Our paper presents the development process for these guidelines. A group of national and international experts was formed and a national situation analysis for tobacco dependence treatment practices and a detailed review of international evidence were conducted. The guidelines were then drafted and reviewed by national, regional and international experts and were official endorsed by the Jordanian Ministry of Health before being launched. The guidelines comprise concise descriptions and practical supplementary flowcharts covering the major elements of general tobacco dependence treatment. These are the first comprehensive Arabic-language guidelines, including a section focusing on waterpipe use, and we believe they are a reliable and useful resource for neighbouring countries seeking to develop similar guidelines.

Tratar el tabaquismo: una iniciativa global para una necesidad mundial / Treating smoking habit: a global initiative for a worldwide need

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Responsiveness of the Smoking Cessation Quality of Life (SCQoL) questionnaire.

BACKGROUND: The Smoking Cessation Quality of Life (SCQoL) questionnaire was developed to quantify changes in self-reported functioning and well-being associated with the smoking cessation process and to facilitate comparisons among smokers, former smokers, and nonsmokers. The SCQoL includes 5 cessation-targeted scales and the 8 multi-item scales of the Medical Outcomes Study 36-Item Short-Form Health Survey. OBJECTIVE: This study was conducted to assess the responsiveness of the SCQoL by analyzing associations between SCQoL scale scores and duration of smoking abstinence. METHODS: The SCQoL was administered at a screening visit and 2 to 6 weeks after screening as part of a longitudinal study. Study participants included smokers who intended to quit smoking. Subjects were required to purchase nicotine inhalers and were prompted to quit smoking before follow-up. Based on self-reported duration of abstinence at follow-up, subjects were categorized as recidivists (0 days smoke free), short-term abstainers (1-7 days smoke free), or longer-term abstainers (>7 days smoke free). Kruskal-Wallis tests were used to compare changes in scale scores from screening to follow-up among the 3 groups. RESULTS: The internal consistency reliability of the 13 SCQoL scales ranged from 0.67 to 0.92. Subjects who maintained abstinence for longer periods experienced smaller declines in health-related quality of life between the screening and follow-up assessments. Differences among the 3 groups were driven primarily by differences between recidivists and longer-term abstainers. CONCLUSIONS: The results are consistent with research indicating that recidivists report a greater number of (and more severe) cessation-related symptoms than abstainers. The findings of this investigation provide evidence for the responsiveness of the SCQoL.

Late-term smoking cessation despite initial failure: an evaluation of bupropion sustained release, nicotine patch, combination therapy, and placebo.

OBJECTIVE: The purpose of this study was to evaluate the efficacy of long-term use of bupropion sustained release (SR), the nicotine patch, and the combination of these 2 treatments in patients who initially failed treatment. METHODS: This was a post hoc analysis of a multicenter, double-blind, randomized, placebo-controlled clinical trial in 893 smokers. Patients were randomly assigned to 9 weeks of treatment with placebo (n = 160), bupropion SR (n = 244), nicotine patch (n = 244), or a combination of nicotine patch and bupropion SR (n = 245). The study was originally designed with a follow-up period of 52 weeks. In this analysis, short-term success was defined as smoking cessation after 14 or 21 days of therapy and long-term success was defined as smoking cessation after >21 days of therapy. Patients who did not achieve short-term success were evaluated for long-term success at week 9 (end of treatment), 6 months, and 1 year after the start of the study. RESULTS: The mean age of the smokers was 44 years. The majority (93%) of patients were white, and 52% were female. The study subjects smoked an average of 27 cigarettes per day. Among the 467 patients who initially failed treatment in the first 3 weeks, treatment with bupropion SR alone and in combination with the nicotine patch produced significant increases in successful smoking cessation rates from weeks 4 to 9 (19% bupropion SR or combination, 7% nicotine patch, 7% placebo), at month 6 (11% bupropion SR, 13% combination, 2% nicotine patch, 3% placebo), and at month 12 (10% bupropion SR, 7% combination, 2% nicotine patch, 1% placebo) (P < 0.05 for bupropion SR and combination vs nicotine patch or placebo). CONCLUSION: Among patients who initially failed treatment, continued therapy with bupropion SR, either alone or in combination with the nicotine patch, resulted in significantly higher short- and long-term smoking cessation rates than treatment with the nicotine patch alone or placebo.

Couple dynamics of change-resistant smoking: toward a family consultation model.

Smoking is North America's leading cause of preventable morbidity and mortality. Although effective cessation treatments exist, their overall effect is modest, and they rarely reach the high-risk, health-compromised smokers who need them most. Surprisingly, despite evidence that marital relationship variables predict the success of cessation efforts, family systems ideas have had little impact on current intervention research. We review and critique the cessation literature from a systemic viewpoint, illustrate two couple-interaction patterns relevant to the maintenance of high-risk smoking, and outline a family-consultation (FAMCON) intervention for couples in which at least one partner continues to smoke despite having heart or lung disease. Taking into account ironic processes and symptom-system fit, FAMCON focuses on the immediate social context of smoking, aiming to interrupt well-intentioned "solutions" that ironically feed back to keep smoking going, and to help clients realign important relationships in ways not organized around tobacco usage. Currently in its pilot-testing phase, FAMCON is an adjunctive, complementary approach designed to include collaboration with primary-care physicians and to make smokers more amenable to other, evidence-based cessation strategies.

Advancing the science of adolescent tobacco use cessation.

OBJECTIVE: To examine how science is advancing in order to address adolescent tobacco use cessation. METHODS: Review of the published scientific literature from 1995 to September 2000 and National Cancer Institute youth tobacco cessation research portfolio. RESULTS: Because of methodological limitations, results of behavioral interventions are inconclusive. Two studies have been published evaluating the nicotine patch for adolescent smoking cessation, though neither employed a randomized, placebo-control design. Both of these studies found the nicotine patch to be ineffective. CONCLUSIONS: Although much is known about youth tobacco use, additional research is needed to find answers to best help youth to quit smoking.

Addressing social and cultural disparities in tobacco use.

Disparities in smoking as a function of ethnicity exist, but part of that disparity appears to be mediated by education level. Smoking prevalence differences by ethnicity disappear or decrease substantially when controlling for education level. Nonetheless, ethnicity remains an important consideration when striving to understand the mechanisms associated with smoking, as well as in the development of smoking prevention and treatment programs. In this paper, the complex interrelationships among ethnicity, social class, and smoking are discussed in brief, and a framework for developing a systematic means of addressing social disparities in tobacco use is described.

Tobacco cessation skills certification in Arizona: application of a state wide, community based model for diffusion of evidence based practice guidelines.

OBJECTIVE: To describe the development and preliminary results from a community based certification model for training in tobacco cessation skills in Arizona. DESIGN: A programme evaluation using both quantitative pre-post measures and qualitative methods. SETTING: Arizona's comprehensive tobacco control programme of state funded, community based local projects and their community partners providing tobacco treatment services for geographically, socioeconomically, and ethnically diverse communities. INTERVENTION: A three tiered model of skills based training emphasising Agency for Health Care Policy and Research guidelines, and utilising a training of trainers approach to build community capacity. Certification roles addressed basic tobacco cessation skills, tobacco cessation specialist, and tobacco treatment services manager. PARTICIPANTS: Initial target audience was community based local project personnel and their community partners, with later adoption by community organisations unaffiliated with local projects, and the general public. MAIN EVALUATION MEASURES: Process measures: participant satisfaction, knowledge, skills, and self-efficacy. OUTCOME: participant demographics, community organisations represented, post-training, cessation related activities. RESULTS: During the model's implementation year, 1075 participants attended certification training, 947 participants received basic skills certificates and 82 received specialist certificates. Pre, post, and three month measures of self efficacy showed significant and durable increases. Analysis of participant characteristics demonstrated broad community representation. At post-training follow up, 80.9% of basic skills trainees had performed at least one brief intervention and 74.8% had made a referral to intensive services. Among cessation specialists, 48.8% were delivering intensive services and 69.5% were teaching basic skills classes. CONCLUSIONS: Initial experience with Arizona's state wide, community based model for certification of tobacco cessation skills training suggests this model may be a promising method for broad, population based diffusion of evidence based tobacco cessation guidelines.

Efficacy of transdermal nicotine in reducing post-cessation weight gain in a Hispanic sample.

This study examined nicotine replacement effects and pre-quit smoking characteristics with respect to post-cessation weight gain in a primarily Mexican-American sample of Hispanic smokers. Hispanic smokers (108) were randomly assigned to receive either nicotine transdermal patch or placebo patch for 10 weeks, during which time smoking status and weight change were measured. The overall weight gain experienced by the successful quitters was greater than that experienced by non-quitters. Differences between quitters and non-quitters were significant for both females (2.0 vs. 0.86 kg; p < 0.05) and for males (2.3 vs. 1.2 kg; p < 0.05) at 6 weeks post-randomization. At the end of the 10-week treatment, only the females showed a significant difference in weight gain between the quitters and non-quitters (2.8 vs. 1.1; p < 0.01). Results of the random effects regression models for quitters indicated that the active group gained weight at a significantly lower rate than the placebo group (p = 0.047) for females, but not for males (p = 0.87). Years of smoking (p = 0.001) but not baseline cigarettes (p = 0.13) were significant predictors of weight for females, but not for males (p = 0.24 and 0.72, respectively). The use of nicotine patch treatment for smoking cessation effectively attenuated weight gain for successful female quitters compared with placebo-treated quitters. Identification of pre-quit smoking characteristics may prove useful in predicting who is most likely to gain weight when quitting smoking.

An evaluation of NicCheck I: a dipstick method for analyzing nicotine and its metabolites.

This study examined the reliability of a test strip for assessing urinary nicotine and its metabolites. Urine samples from smokers were tested by two independent raters using the NicCheck I test strips. Each rater compared the test strip color to a five-color chart. Correlations between the rater's codings and between the coding and other measures of nicotine consumption were examined. Significant correlations were found between the two independent ratings of the test strip color and between the codings and other measures of nicotine consumption. This preliminary evaluation suggests that NicCheck I is sensitive to differences in nicotine consumption.

A controlled trial of sustained-release bupropion, a nicotine patch, or both for smoking cessation.

BACKGROUND AND METHODS: Use of nicotine-replacement therapies and the antidepressant bupropion helps people stop smoking. We conducted a double-blind, placebo-controlled comparison of sustained-release bupropion (244 subjects), a nicotine patch (244 subjects), bupropion and a nicotine patch (245 subjects), and placebo (160 subjects) for smoking cessation. Smokers with clinical depression were excluded. Treatment consisted of nine weeks of bupropion (150 mg a day for the first three days, and then 150 mg twice daily) or placebo, as well as eight weeks of nicotine-patch therapy (21 mg per day during weeks 2 through 7, 14 mg per day during week 8, and 7 mg per day during week 9) or placebo. The target day for quitting smoking was usually day 8. RESULTS: The abstinence rates at 12 months were 15.6 percent in the placebo group, as compared with 16.4 percent in the nicotine-patch group, 30.3 percent in the bupropion group (P<0.001), and 35.5 percent in the group given bupropion and the nicotine patch (P<0.001). By week 7, subjects in the placebo group had gained an average of 2.1 kg, as compared with a gain of 1.6 kg in the nicotine-patch group, a gain of 1.7 kg in the bupropion group, and a gain of 1.1 kg in the combined-treatment group (P<0.05). Weight gain at seven weeks was significantly less in the combined-treatment group than in the bupropion group and the placebo group (P<0.05 for both comparisons). A total of 311 subjects (34.8 percent) discontinued one or both medications. Seventy-nine subjects stopped treatment because of adverse events: 6 in the placebo group (3.8 percent), 16 in the nicotine-patch group (6.6 percent), 29 in the bupropion group (11.9 percent), and 28 in the combined-treatment group (11.4 percent). The most common adverse events were insomnia and headache. CONCLUSIONS: Treatment with sustained-release bupropion alone or in combination with a nicotine patch resulted in significantly higher long-term rates of smoking cessation than use of either the nicotine patch alone or placebo. Abstinence rates were higher with combination therapy than with bupropion alone, but the difference was not statistically significant.

Are higher doses of nicotine replacement more effective for smoking cessation?

This study determined whether higher dose nicotine patches are more efficacious than lower dose patches among heavy smokers. A randomized double-blind study compared 0, 21, 35, and 42 mg/day of a 24-h patch in 1039 smokers (> or = 30 cigarettes/day) at 12 clinical sites in the USA and one in Australia. Daily patches were used for 6 weeks followed by tapering over the next 10 weeks. Weekly group therapy occurred. Biochemically validated self-reported quit rates at 6, 12, 26, and 52 weeks post-cessation were measured. Quit rates were dose-related at all follow-ups (p < 0.01). Continuous, biochemically verified abstinence rates for the 0, 21, 35, and 42 mg doses at the end of treatment (12 weeks) were 16, 24, 30, and 39%. At 6 months, the rates were 13, 20, 20, and 26%. Among the 11 sites with 12 month follow-up (n = 879), the quit rates were 7, 13, 9, and 19%. In post-hoc tests, none of the active doses were significantly different from each other at any follow-up. The rates of dropouts due to adverse events for 0, 21, 35, and 42 mg were 3, 1, 3, and 6% (p = n.s.). Our results are similar to most prior smaller studies; i.e., in heavy smokers higher doses increase quit rates slightly. Longer durations of treatment may be necessary to show greater advantages from higher doses.

Development of the Smoking Cessation Quality of Life questionnaire.

This paper describes the development of the Smoking Cessation Quality of Life (SCQoL) questionnaire, a self-reported measure designed to quantify the impact of smoking cessation on perceived functioning and well-being in adults. In addition to incorporating the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) as a generic core, the SCQoL contains 5 multi-item cessation-targeted scales: social interactions, self-control, sleep, cognitive functioning, and anxiety. The draft SCQoL was developed through a series of focus groups and was pilot-tested in a sample of 101 adults. Respondents were predominantly male (59.2%), with a mean (SD) age of (48.6) (12.7) years and a mean (SD) smoking history of 29.3 (14.7) years. Of the respondents, 76.5% identified themselves as current smokers and 23.5% indicated that they were former smokers. The majority of former smokers (82.6%) reported being abstinent for > or =2 weeks. Multivariate analysis of variance was used to compare scale scores between smokers and former smokers who had been abstinent for > or =2 weeks. Former smokers reported significantly higher scores than did current smokers on 3 of 8 SF-36 scales and 3 of 5 cessation-targeted scales (P < 0.05). In no case did current smokers report significantly higher scale scores than did former smokers. The internal-consistency reliability of the SCQoL scales ranged from 0.68 to 0.96, exceeding 0.70 on 12 of 13 scales. These findings provide preliminary evidence for the reliability and construct validity of the SCQoL.

Saliva cotinine levels as a function of collection method.

Saliva cotinine is commonly used to estimate nicotine intake but laboratories use different methods of collection. In three small trials, comparisons were made between (1) sugar vs. unstimulated saliva production (n = 29), (2) wax chewing vs. unstimulated production (n = 15) and (3) between two consecutive unstimulated saliva samples (n = 10). Sugar-stimulated saliva cotinine scores were 26% below unstimulated levels (p < 0.001); correlation between measures was high (r = 0.90; p < 0.001). Wax stimulated saliva yielded levels 6% below unstimulated (p < 0.05; correlation: r = 0.98; p < 0.001). No differences were observed between two unstimulated samples taken within a approximately 20-minute period (correlation: r = 0.99; p < 0.001). It is postulated that changes in salivary flow can account for the findings.

Effects of nicotine dose and administration method on withdrawal symptoms and side effects during short-term smoking abstinence.

The effects of using several nicotine replacement treatments on self-reported withdrawal symptoms and side effects during 2-day periods of smoking cessation, with 5 days of ad lib smoking between cessation days, were evaluated. Participants (N = 18) experienced the following conditions: nicotine gum, 24-hr patch, 16-hr patch, 24-hr patch plus gum, double 24-hr patch, and no nicotine replacement. The present study found morning urge to smoke was greater during the 16-hr than during the 24-hr patch condition. Double-patch use resulted in significantly greater insomnia than the smoking baseline and 16-hr patch conditions. The no medication and gum alone conditions resulted in similar withdrawal symptoms, and both tended to result in greater reported withdrawal symptoms than the smoking baseline condition. There were no significant withdrawal symptom differences between the 24-hr, patch-gum, and double-patch conditions. The 24-hr and double-patch conditions were preferred by two thirds of the participants (6 each).

A retrospective analysis of the costs and consequences of a tobacco-cessation program for active duty service members.

Health system records of 126 active-duty (AD) service members who were participants in the Davis-Monthan AFB "Quitters are Winners" tobacco cessation program (QAWP) between June 1993 and May 1994 were reviewed retrospectively during the fall of 1994. Participants received an average of 2.84 (+/- 1.46) prescriptions for transdermal nicotine replacement therapy representing 6 weeks duration. Tobacco abstinence, determined by 6-month point prevalence abstinence (PPA), was 19.05 and 15.08% for 6-month continuous abstinence (CA). PPA and CA rates were significantly higher than expected (z = 3.94, p < 0.002; z = 2.38, p < 0.02). Average operational cost per successful outcome at 6 months after entry into the QAWP were $778.93 using PPA and $983.92 using CA. Additional analyses revealed corresponding increases between average cost per successful outcome and duration of TNRT. This research provides an initial analysis of the efficiency of the QAWP for AD participants and a model for subsequent evaluations within military medical treatment facilities.

Involuntary smoking cessation: a treatment option in chemical dependency programs for women and children.

Recent research has indicated that a relationship exists between nicotine addiction and the abuse of other substances. This relationship, as well as the severe impact of nicotine addiction on the health of women, their children, and the developing fetus, provides the basis of a rationale for developing chemical dependency programs for women where smoking is not allowed. Involuntary smoking cessation (ISC) programs have been tried recently in mixed-gender and male-only programs, and have met with strong resistance from clients. In most published reports this resistance was strong enough to force the programs to eliminate the ISC policy. This article describes the development of an ISC program at a residential substance abuse treatment center for pregnant and postpartum women and their children. It traces the evolution of tactics to defuse resistance and enlist client support for the program. The development of techniques to measure the effectiveness of the program are also presented. Preliminary results indicate that a properly designed program can be instituted at a residential treatment center for women without excessive program disruption and with positive results.

Effect of nicotine vapour inhalation on the relief of tobacco withdrawal symptoms.

Fifteen subjects participated in a randomised, placebo-controlled cross-over study to assess the effect of a nicotine vapour inhaler on craving and other withdrawal symptoms during a two-day smoking-free period. Craving and withdrawal symptoms were rated nine times over the two-day period on 10 cm visual analogue scales. Plasma nicotine concentrations in the afternoon of each study day were determined. The results show that active treatment was significantly superior to placebo in decreasing craving and other withdrawal symptom scores. No difference was found between two inhalation techniques, one with shallow, frequent inhalations (buccal technique), and the other with deep inhalations (pulmonary technique). The average number of active nicotine vapour inhalers and placebo inhalers used during the two-day sessions was 12 and 11, respectively. Afternoon plasma nicotine levels of approximately 7 ng/ml were obtained with both inhalation techniques. A strong correlation was found between the afternoon plasma nicotine levels and craving, a high nicotine level being associated with a low craving score. The study has provided information about how to use the nicotine vapour inhaler that could have important implications if it were to be approved for the treatment of tobacco dependence. The use of withdrawal symptom reduction as a surrogate end-point is discussed.

Nicotine polacrilex dose effects: serum nicotine levels and sensory characteristics.

This study evaluated serum nicotine and sensory differences of five different doses of nicotine polacrilex (0.0, 0.5, 1.0, 2.0 and 4.0 mg nicotine), three of which have been used as placebo doses in clinical trials (0.0, 0.5, and 1.0 mg) and two of which are currently available as pharmacologic treatments for smoking cessation (2.0 or 4.0 mg nicotine). Twenty-one smokers received, on different days and in random order, five pieces of each of the five doses of polacrilex. The objective of the study was to evaluate whether consistent serum nicotine and sensory differences would be observed between the doses. After 5 h use, the 0.0, 0.5, 1.0, 2.0, and 4.0 mg doses produced the following results: (1) there was a linear trend across the placebo doses of nicotine polacrilex in serum nicotine and nicotine flavor, although pairwise dose comparisons were not significant, (2) the 0.0 and 0.5 mg placebo doses resulted in serum nicotine and sensory ratings that were significantly different from the 2.0 mg dose, and even more so from the 4.0 mg dose, (3) the 1.0 mg dose was not different from the 2.0 mg dose on serum nicotine level and several sensory characteristics, though it was different from the 4.0 mg dose on both, and (4) the 4.0 mg dose resulted in significantly higher serum nicotine and usually higher sensory ratings than the 2.0 mg dose. Since the 0.0 mg placebo achieves sensory effects that are comparable to the nicotine-containing placebo doses, it is recommended over the 0.5 and 1.0 mg doses as the nicotine polacrilex placebo of choice in most clinical trials.