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1.
Cochrane Database Syst Rev ; (4): CD004306, 2007 Oct 17.
Article in English | MEDLINE | ID: mdl-17943813

ABSTRACT

BACKGROUND: Use of smokeless tobacco (ST) can lead to nicotine addiction and long-term use can lead to health problems including periodontal disease and cancer. OBJECTIVES: To assess the effects of behavioural and pharmacologic interventions for the treatment of ST use. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, CINAHL, Web of Science, PsycINFO, Dissertation Abstracts Online, and Scopus. Date of last search: March, 2007. SELECTION CRITERIA: Randomized trials of behavioural or pharmacological interventions to help users of ST to quit with follow up of at least six months. DATA COLLECTION AND ANALYSIS: Two authors independently extracted data. MAIN RESULTS: Two trials of bupropion SR did not detect a benefit of treatment at six months or longer (Odds Ratio (OR) 0.86, 95% Confidence Interval (CI): 0.47 to 1.57). Four trials of nicotine patch did not detect a benefit (OR 1.16, 95% CI: 0.88 to 1.54), nor did two trials of nicotine gum (OR 0.98, 95% CI: 0.59 to 1.63). There was statistical heterogeneity among the results of 12 behavioural interventions included in the meta-analyses. Six trials showed significant benefits of intervention. In post-hoc subgroup analyses, behavioural interventions which include telephone counselling or an oral examination may increase abstinence rates more than interventions without these components. AUTHORS' CONCLUSIONS: Behavioural interventions should be used to help ST users to quit and telephone counselling or an oral examination may increase abstinence rates. Pharmacotherapies have not been shown to affect long-term abstinence.


Subject(s)
Tobacco Use Cessation/methods , Tobacco, Smokeless , Bupropion/therapeutic use , Chewing Gum , Counseling , Humans , Nicotine/therapeutic use , Nicotinic Agonists/therapeutic use , Randomized Controlled Trials as Topic
2.
Monaldi Arch Chest Dis ; 65(4): 217-21, 2006 Dec.
Article in English | MEDLINE | ID: mdl-17393667

ABSTRACT

AIM: Describe the smoking characteristics and the results of a smoking intervention programme involving 27 cigarette smokers with Thromboangiitis Obliterans (TAO). METHODS: Clinical records of all cigarette smokers with TAO that attended our smoking treatment clinic from 1990 to 2004 were reviewed. Demographic and smoking characteristics, the type of smoking treatment received and its efficacy and safety up to 12 months was abstracted. Treatment consisted of the combination of behavioural and pharmacological treatment. The behavioural treatment was delivered in eight individual visits: one baseline visit and seven follow-up visits. Pharmacological treatment consisted of combinations of nicotine patches and nicotine gum (NRT) and/or bupropion. This is an 'intent to treat' analysis. A descriptive analysis of the variables was performed. Qualitative variable relationships were tested using the chi-square test for independence, or Fisher's Exact Test when expected values were less than five. Statistical significance was accepted at a level of p < 0.05. RESULTS: 27 cigarette smokers (23 male and 4 female), mean (SD) age 36.07 (7.23), mean FTND-score 8.4 (1.4), smoked a mean of 29.6 (7.71) cigarettes daily. They attended our clinic a mean of 45.48 (8.63) months after onset of TAO. Their mean number of attempts to stop was 3.22 (2.75). The continuous abstinence rate decreased from 29% at the end of treatment to 18.5% at 12-month follow up. The seven day point prevalence abstinence rate at the 12th month of follow up was 40.7%. We found that continuous abstinence at 6 and 12 months was more frequent among those with multiple previous stop attempts (p = 0.003 and p = 0.001, respectively). There were no significant differences in abstinence outcomes between groups. Incidence of adverse effects was similar to other smokers seeking treatment. All the smokers who achieved continuous tobacco abstinence had improvement in their disease and none of them underwent amputation, compared to 50% of those who resumed smoking and later required an amputation. CONCLUSIONS: Continuous abstinence rates among treated cigarette smokers with TAO are relatively low, but abstinence does improve symptoms and reduce the likelihood of amputation. More aggressive treatment programmes need to be developed for this high risk, highly tobacco dependent population.


Subject(s)
Smoking Cessation , Smoking/therapy , Thromboangiitis Obliterans/therapy , Adult , Amputation, Surgical , Bupropion/therapeutic use , Chewing Gum , Combined Modality Therapy , Disease Progression , Dopamine Uptake Inhibitors/therapeutic use , Female , Follow-Up Studies , Humans , Male , Nicotine/therapeutic use , Nicotinic Agonists/therapeutic use , Prevalence , Retrospective Studies , Smoking/adverse effects , Spain/epidemiology , Time Factors , Treatment Outcome
3.
Cochrane Database Syst Rev ; (3): CD004306, 2004.
Article in English | MEDLINE | ID: mdl-15266527

ABSTRACT

BACKGROUND: Use of smokeless tobacco (ST) can lead to nicotine addiction and health problems including periodontal disease and oral cancer OBJECTIVES: To assess the effects of behavioural and pharmacotherapeutic interventions to treat ST use. SEARCH STRATEGY: We searched the Cochrane Tobacco Addiction Group trials register (February 2004), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 1, 2004), MEDLINE (January 1966-February 2004), EMBASE (1988-January 2004), CINAHL (1982-February 2004), PsycINFO (1984-February 2004), Database of Abstract of Reviews of Effectiveness (DARE, The Cochrane Library, Issue 1, 2004). SELECTION CRITERIA: Randomized trials of behavioural or pharmacological interventions to help users of ST to quit, with follow-up of at least six months. DATA COLLECTION AND ANALYSIS: Two authors independently extracted data. MAIN RESULTS: One trial of bupropion did not detect a benefit of treatment after six months (Odds Ratio (OR) 1.00, 95% Confidence Interval (CI): 0.23 to 4.37). Three trials of nicotine patch did not detect a benefit (OR 1.16, 95% CI: 0.88 to 1.54), nor did two trials of nicotine gum (OR 0.98, 95% CI: 0.59 to 1.63). There was statistical heterogeneity among the results of eight trials of behavioural interventions included in the meta-analysis. Three trials showed significant benefits of intervention. In a post-hoc analysis the trials of interventions which included an oral examination and feedback about ST-induced mucosal changes had homogeneous results and when pooled showed a significant benefit (OR 2.41 95% CI: 1.79 to 3.24). REVIEWERS' CONCLUSIONS: Behavioural interventions should be used to help ST users to quit. Pharmacotherapies have not been shown to affect long-term abstinence but larger trials are needed.


Subject(s)
Tobacco Use Cessation/methods , Tobacco, Smokeless , Bupropion/therapeutic use , Counseling , Humans , Nicotine/therapeutic use , Nicotinic Agonists/therapeutic use , Randomized Controlled Trials as Topic
4.
Prev Med ; 33(4): 229-38, 2001 Oct.
Article in English | MEDLINE | ID: mdl-11570825

ABSTRACT

BACKGROUND: Quit and Win is a community-wide stop smoking contest to help cigarette smokers stop smoking and educate the general public concerning smoking hazards. METHODS: All community residents, 15 years of age or older, were eligible to participate in either the stop smoking contest or the supporter contest. A random telephone survey to local households was conducted before and after the Quit and Win contest to assess the level of knowledge and attitude changes about smoking. RESULTS: Of the 304 smokers enrolled in the contest, 42% self-reported continuous tobacco abstinence for the 4-week contest period and 11% were abstinent at 1 year postcontest. Significant predictors for tobacco abstinence during the contest were formal education beyond high school, absence of other smokers in the household, having a support person enrolled in the support person contest, and the type of relationship that the support person had with their smoker. Survey results showed that this contest changed some local attitudes and increased general knowledge of smoking hazards. CONCLUSIONS: Community-wide stop smoking contests can be used to engage smokers and their support in the community and can be successful in reducing tobacco use.


Subject(s)
Community Health Planning/methods , Gambling , Health Promotion/methods , Outcome Assessment, Health Care , Smoking Cessation/methods , Adolescent , Adult , Aged , Analysis of Variance , Female , Health Knowledge, Attitudes, Practice , Humans , Logistic Models , Male , Middle Aged , Minnesota
5.
Chest ; 119(5): 1357-64, 2001 May.
Article in English | MEDLINE | ID: mdl-11348939

ABSTRACT

OBJECTIVES: To identify predictors of smoking abstinence at the end of medication use that could assist in the optimal use of a sustained-release (SR) form of bupropion for treating cigarette smokers. DESIGN: A double-blind, placebo-controlled, dose-response trial. SETTING: Multicenter (three sites) study conducted in the United States. PARTICIPANTS: Six hundred fifteen healthy men and women (> or = 18 years of age) who were smoking > or = 15 cigarettes per day and who were motivated to stop smoking. INTERVENTION: Random assignment of patients to placebo or SR bupropion treatment, 100, 150, or 300 mg/d, for 7 weeks (total duration of study was 52 weeks: 7 weeks of treatment and 45 weeks of follow-up). MEASUREMENTS AND RESULTS: Logistic regression was used to identify predictors of abstinence at the end of the medication phase. Univariate predictors included the following: bupropion dose (p < 0.001); older age (p = 0.024); lower number of cigarettes smoked per day (cpd) (p < 0.001); lower Fagerström Tolerance Questionnaire score (p = 0.011); longest time previously abstinent that was < 24 h or > 4 weeks (p < 0.001); absence of other smokers in the household (p = 0.021); greater number of previous stop attempts (p = 0.019); and study site (p = 0.004). Multivariate predictors of abstinence at the end of the medication phase were the following: higher bupropion dose (p < 0.001); lower number of cpd (p < 0.001); longest time previously abstinent from smoking (p = 0.002); male gender (p = 0.014); and study site (p = 0.021). CONCLUSION: Bupropion SR therapy was effective in treating cigarette smokers independently of all other characteristics studied. Lower smoking rate, brief periods (ie, < 24 h) or long periods (ie, > 4 weeks) of abstinence with previous attempts to stop smoking, and male gender were predictive of better outcomes, independent of the dose of bupropion that was used.


Subject(s)
Bupropion/therapeutic use , Dopamine Uptake Inhibitors/therapeutic use , Smoking Cessation , Adult , Aged , Double-Blind Method , Female , Humans , Male , Middle Aged , Prognosis , Remission Induction
6.
Mayo Clin Proc ; 76(2): 144-51, 2001 Feb.
Article in English | MEDLINE | ID: mdl-11213302

ABSTRACT

OBJECTIVE: To describe a medical student-run smoking intervention clinic, report initial outcomes, and assess medical student competence in smoking intervention counseling. PATIENTS AND METHODS: Volunteer medical students of Mayo Medical School in Rochester, Minn, staffed a free smoking intervention clinic in conjunction with the Salvation Army Free Acute Care Clinic between December 1997 and January 1999. Patients received a comprehensive intervention for smoking that comprised counseling, frequent follow-up contact, and pharmacologic therapy, including bupropion and nicotine replacement. Eighty-eight patients seen during the first 13 months of the clinic's operation and 30 medical student volunteer counselors were included in the study. Patients were contacted via telephone to assess 6-month self-reported smoking abstinence. Medical student counselors completed a self-assessment questionnaire surveying competence before and after working in the clinic. RESULTS: The 6-month self-reported smoking abstinence rate was 18% (95% confidence interval, 11%-28%). Twelve of 14 medical students completing the survey reported improved competence in smoking intervention counseling. CONCLUSIONS: A comprehensive smoking intervention program provided by medical students yielded smoking abstinence rates comparable to other treatment programs. Medical students believed they improved their smoking cessation counseling skills.


Subject(s)
Smoking Cessation , Students, Medical , Adult , Counseling , Female , Humans , Male , Middle Aged , Minnesota , Student Health Services/organization & administration
7.
Mayo Clin Proc ; 75(12): 1311-6, 2000 Dec.
Article in English | MEDLINE | ID: mdl-11126841

ABSTRACT

Nicotine dependence is characterized by periods of relapse and remission. Health care workers can have a pivotal role in the treatment of nicotine dependence. Smokers should be identified and categorized based on their readiness to change. Smokers who are preparing to stop smoking should be given multicomponent therapy in a step-care approach using behavioral treatment, addiction treatment, pharmacotherapy, and techniques of relapse prevention. Pharmacotherapies approved by the Food and Drug Administration for smoking interventions include sustained-release bupropion, nicotine gum, the nicotine inhaler, nicotine nasal spray, and nicotine patches.


Subject(s)
Smoking Cessation/methods , Tobacco Use Disorder/therapy , Adaptation, Psychological , Antidepressive Agents/therapeutic use , Behavior Therapy/methods , Combined Modality Therapy , Humans , Nicotine/therapeutic use , Smoking Cessation/psychology , Tobacco Use Disorder/psychology
8.
Mayo Clin Proc ; 75(11): 1153-9, 2000 Nov.
Article in English | MEDLINE | ID: mdl-11075745

ABSTRACT

OBJECTIVE: To establish baseline data for the CardioVision 2020 program, a collaborative project in Olmsted County, Minnesota, organized to reduce cardiovascular disease rates by altering 5 health-related items: (1) eliminating tobacco use and exposure, (2) improving nutrition, (3) increasing physical activity, (4) lowering serum cholesterol level, and (5) controlling blood pressure. SUBJECTS AND METHODS: Data about tobacco use, diet, and physical activity were collected by random digit dial interview and follow-up questionnaire from a sample of the population. Blood pressure data were collected from medical records at Mayo Clinic, and serum cholesterol data were derived from the Mayo Clinic laboratory database. Data were stratified into 6 age groups. RESULTS: A total of 624 women and 608 men responded to the questionnaire. Population blood pressure data were available for 1,956 women and 1,084 men. Population serum cholesterol data were available for 17,042 women and 12,511 men. Except for women in the 30- to 39-year-old age group, less than 10% of the population sampled met 4 or 5 goals. Conversely, about 90% of the population met at least 1 goal, and about 80% met 1, 2, or 3 of the goals. CONCLUSION: The data from the Olmsted County population indicate considerable opportunity to reduce this population's burden of cardiovascular disease.


Subject(s)
Cardiovascular Diseases/prevention & control , Health Behavior , Health Surveys , Adult , Aged , Blood Pressure , Cholesterol/blood , Female , Humans , Life Style , Male , Middle Aged , Minnesota , Risk-Taking
9.
Mayo Clin Proc ; 74(12): 1198-206, 1999 Dec.
Article in English | MEDLINE | ID: mdl-10593347

ABSTRACT

OBJECTIVE: To determine the efficacy of stanol esters in lowering cholesterol in a US population. SUBJECTS AND METHODS: After a run-in phase, 318 subjects were randomized to receive one of the following margarine-like spreads containing stanol ester or placebo for 8 weeks: EU 3 G: 1 g of stanol (ester form) per 8-g serving of a European formula 3 times a day; US 3 G: 1 g of stanol (ester form) per 8-g serving of a US reformulation 3 times a day; US 2 G: 0.67 g of stanol (ester form) per 8-g serving of a US reformulation 3 times a day; or placebo spread. RESULTS: Mean +/- SD baseline total cholesterol (TC) and low-density lipoprotein cholesterol (LDL-C) levels were 233+/-20 and 153+21 mg+/-dL, respectively. In the US 3 G group, 3 g daily of stanol esters lowered TC and LDL-C levels by 6.4% and 10.1%, respectively. There was a dose-dependent response compared with 2 g daily (US 2 G). Triglyceride and high-density lipoprotein cholesterol levels were unchanged. The incidence of adverse effects was not different from placebo. Serum vitamin A and 25-hydroxyvitamin D levels were not affected. CONCLUSIONS: Stanol esters lowered TC and LDL-C levels in a mildly hypercholesterolemic US population without evidence of adverse effects. It may be a useful dietary adjunct to lower cholesterol.


Subject(s)
Anticholesteremic Agents/pharmacology , Cholestanols/metabolism , Cholesterol/blood , Dietary Fats/pharmacology , Hypercholesterolemia/drug therapy , Phytosterols/pharmacology , Adult , Anticholesteremic Agents/administration & dosage , Cholesterol/analogs & derivatives , Cholesterol, HDL/blood , Cholesterol, LDL/blood , Dietary Fats/administration & dosage , Dose-Response Relationship, Drug , Double-Blind Method , Esters/administration & dosage , Esters/pharmacology , Female , Humans , Hypercholesterolemia/blood , Hypercholesterolemia/diet therapy , Male , Middle Aged , Phytosterols/administration & dosage , Phytosterols/blood , Sitosterols/blood , Treatment Outcome , Triglycerides/blood , United States , Vitamin A/blood , Vitamin D/analogs & derivatives , Vitamin D/blood , beta Carotene/blood
11.
Clin Chem ; 45(1): 85-91, 1999 Jan.
Article in English | MEDLINE | ID: mdl-9895342

ABSTRACT

trans-3'-Hydroxycotinine (THOC) has been recognized as the most abundant metabolite of nicotine. In an attempt to assess THOC and cotinine (COT) concentrations during nicotine transdermal therapy, we developed a new quantitative gas chromatography-mass spectrometry (GC-MS) method for simultaneous determination of total and free THOC and COT in human urine. The method utilizes the following: (a) hydrolysis of conjugated THOC and COT by beta-glucuronidase; (b) basic extraction of THOC and COT with mixed dichloromethane and n-butyl acetate; (c) derivatization of THOC with bis(trimethylflurosilyl)acetamide; and (d) separation and identification by GC-MS with selective ion monitoring. Lower limits of quantification for the assay were 50 and 20 microg/L for THOC and COT, respectively. The intra- and interassay CVs were 4.4% and 11% for THOC, and 3.9% and 10% for COT at 1000 microg/L. The results from six consecutive 24-h urine collections in 71 subjects administered daily transdermal nicotine doses of 11, 22, and 44 mg showed that, on average, free THOC was 76% of total THOC and free COT was 48% of total COT in all subjects. THOC is the major metabolite of nicotine and constitutes 20% of total nicotine intake at steady state, whereas urinary nicotine and COT excretion were 8% and 17%, respectively. The method is useful for simultaneous determination of free and total THOCand COT and can be used to assess the urinary excretion of these metabolites during transdermal nicotine therapy.


Subject(s)
Cotinine/analogs & derivatives , Nicotine/metabolism , Nicotinic Agonists/metabolism , Smoking Cessation , Administration, Cutaneous , Cotinine/urine , Gas Chromatography-Mass Spectrometry , Humans , Nicotine/administration & dosage , Nicotine/therapeutic use , Nicotinic Agonists/administration & dosage , Nicotinic Agonists/urine , Sensitivity and Specificity , Smoking/urine
12.
Psychopharmacology (Berl) ; 140(1): 98-104, 1998 Nov.
Article in English | MEDLINE | ID: mdl-9862408

ABSTRACT

Nicotine nasal spray and nicotine gum have been found to be effective in relieving nicotine withdrawal symptoms. In this randomized single-blind study, 91 cigarette smokers were randomly assigned to a single 1 mg dose of active nicotine nasal spray (n=29), active 4 mg nicotine gum (n=31), saline placebo nasal spray (n=16) or placebo gum (n=15). Following overnight abstinence, subjects repeatedly completed visual analog scales for assessing nicotine withdrawal symptoms over 30 min preceding (time -30 min to time 0) and 120 min following a single dose of study medication. This sequence was performed 3 times during the day. Nicotine withdrawal symptoms were assessed on a 41-point visual analog scale (1=no withdrawal, 41=extreme withdrawal). At the initial session only, blood samples for serum nicotine levels were taken at baseline, then at 5, 10, 30 and 120 min following study drug administration. The mean (+/-SD) age of the subjects was 38.6 (+/-10.1) years, 48% were females, smoking rate was 24.5 (+/-7.8) cigarettes per day, and years of smoking was 19.9 (+/-10.0). A single 1 mg dose of nicotine nasal spray provided more immediate relief for craving for a cigarette compared to a single 4 mg dose of nicotine gum. Serum venous nicotine levels for the active nicotine nasal spray and nicotine gum were comparable at 5 and 10 min while the levels were higher for nicotine gum at 30 and 120 min. Changes in withdrawal symptoms were not found to be related to serum venous nicotine levels. Our findings provide a rationale for the as needed use of nicotine nasal spray to control withdrawal symptoms, possibly in combination with other medications with longer acting effects.


Subject(s)
Nicotine/administration & dosage , Substance Withdrawal Syndrome/drug therapy , Adult , Female , Humans , Male , Middle Aged , Nicotine/blood , Single-Blind Method
13.
Postgrad Med ; 104(6): 56-62, 65-6, 71, 1998 Dec.
Article in English | MEDLINE | ID: mdl-9861256

ABSTRACT

Although millions of Americans have kicked the habit, the effects of cigarette smoking likely will be around for a long time. What was once regarded as a glamorous habit is now recognized as a health threat and an economic burden. But what headway has been made in the reduction of related morbidity and mortality? The authors of this article review the current epidemiologic data on smoking-related diseases and make an indisputable case for smoking cessation.


Subject(s)
Smoking Cessation , Smoking/adverse effects , Cardiovascular Diseases/etiology , Cerebrovascular Disorders/etiology , Coronary Disease/etiology , Cost-Benefit Analysis , Humans , Lung Diseases, Obstructive/etiology , Lung Neoplasms/etiology , Smoking/economics , Smoking Cessation/economics
14.
Postgrad Med ; 104(6): 75-8, 83-4, 1998 Dec.
Article in English | MEDLINE | ID: mdl-9861257

ABSTRACT

The arsenal of pharmacologic agents available for smoking cessation has expanded in the last few years, and it is likely to continue to do so. It is important that practicing physicians keep abreast of new methods as they become available and encourage patients who smoke to undertake cessation measures. Nicotine-replacement therapy is available in gum, patch, nasal spray, or inhaler form, and bupropion therapy aids in smoking cessation through dopaminergic activity. The foundation of effective intervention is likely to remain unchanged: an individualized plan addressing behavioral, addictive, pharmacologic, and relapse-prevention components. In addition to the necessary information about treatment choices, physicians should offer motivation, support, and follow-up to their patients who wish to quit smoking.


Subject(s)
Smoking Cessation/methods , Administration, Cutaneous , Administration, Inhalation , Administration, Intranasal , Bupropion/administration & dosage , Dopamine Uptake Inhibitors/administration & dosage , Humans , Nicotine/administration & dosage
15.
Postgrad Med ; 104(6): 89-94, 1998 Dec.
Article in English | MEDLINE | ID: mdl-9861258

ABSTRACT

Helping patients stop smoking is one of the most important--and frustrating--services primary care physicians can provide. Many physicians are reluctant to spend time talking about tobacco use with patients who show little or no interest in changing their habits. Fortunately, specific technique have been identified that can make the task easier. This article from the distinguished Nicotine Dependence Center of the Mayo Clinic looks at the "best practices" for dealing with nicotine dependence.


Subject(s)
Counseling/methods , Smoking Cessation/methods , Humans , Interview, Psychological , Motivation
16.
J Clin Pharmacol ; 38(6): 502-9, 1998 Jun.
Article in English | MEDLINE | ID: mdl-9650539

ABSTRACT

As part of a clinical trial investigating the level of nicotine replacement with different doses of transdermal therapy for smoking cessation, peak and trough serum nicotine and plasma cotinine concentrations were measured in 70 subjects while they were actively smoking (baseline) and daily for 6 consecutive inpatient days while they were receiving transdermal nicotine. Subjects were randomly assigned to a daily 24-hour patch delivering a transdermal nicotine dose of 0, 11, 22, or 44 mg and stratified by self-reported smoking rate as either light (10-15 cigarettes per day), moderate (16-30 cigarettes per day), or heavy (>30 cigarettes per day). Steady-state concentrations of nicotine and cotinine were attained in 1 and 3 days, respectively, at all doses and were independent of baseline smoking rate. Mean percentage replacement of nicotine was calculated by dividing steady-state peak nicotine or cotinine concentrations by their respective baseline concentrations. Significant underreplacement occurred in subjects receiving the 11 mg/day patch regardless of baseline smoking rate. Underreplacement also occurred in moderate and heavy smokers receiving 22 mg/day and in light smokers at this same dose. Complete replacement occurred only in subjects receiving the 44 mg/day patch. These results have several implications for transdermal nicotine therapy. First, with the higher nicotine and cotinine levels observed with heavier smoking, it is inherent that one size does not fit all, and there is a need to consider more individualization of dosage for nicotine patch therapy. Second, there is substantial underreplacement with the 22 mg/day dose in moderate to heavy smokers and in some light smokers. Third, even with twice the usual dose (i.e., 44 mg/day), there was no accumulation of either nicotine or cotinine. Plasma cotinine levels after achievement of steady state (i.e., after 3 days of patch therapy) can be collected at any time and used to calculate percent replacement using baseline levels.


Subject(s)
Cotinine/blood , Nicotine/therapeutic use , Nicotinic Agonists/therapeutic use , Smoking Cessation , Smoking/drug therapy , Administration, Cutaneous , Adult , Aged , Cotinine/administration & dosage , Female , Humans , Male , Middle Aged , Nicotine/administration & dosage , Nicotine/blood , Nicotinic Agonists/administration & dosage , Nicotinic Agonists/blood , Smoking/metabolism
17.
J Clin Pharmacol ; 38(6): 510-6, 1998 Jun.
Article in English | MEDLINE | ID: mdl-9650540

ABSTRACT

As part of a clinical trial investigating the level of nicotine replacement with different doses of transdermal therapy for smoking cessation, urine excretion rates of nicotine and cotinine were measured in 70 subjects while they were actively smoking (baseline) and for 6 consecutive inpatient days while they were receiving transdermal nicotine therapy. Subjects were stratified according to baseline smoking rate as light (10-15 cigarettes per day), moderate (16-30 cigarettes per day), or heavy (>30 cigarettes per day) smokers and randomly assigned to a daily 24-hour patch delivering a transdermal nicotine dose of 0, 11, 22, or 44 mg. Steady-state excretion rates of nicotine and cotinine were attained in 2 and 3 days, respectively, at all doses and were independent of smoking rate. Percentage replacement of nicotine was calculated by dividing steady-state nicotine or cotinine excretion rates by their respective baseline excretion rates. Significant underreplacement occurred with the 11-mg/day dose, particularly in moderate and heavy smokers (<50%). At a dose of 22 mg/day, nicotine replacement was still <100% in the majority of subjects. Only at a dose of 44 mg/day did mean replacement exceed 100% regardless of baseline smoking rate.


Subject(s)
Cotinine/urine , Nicotine/urine , Nicotinic Agonists/urine , Smoking Cessation , Smoking/urine , Administration, Cutaneous , Double-Blind Method , Humans , Metabolic Clearance Rate , Nicotine/administration & dosage , Nicotine/therapeutic use , Nicotinic Agonists/administration & dosage , Nicotinic Agonists/therapeutic use , Smoking/drug therapy , Smoking/metabolism
18.
Mayo Clin Proc ; 73(2): 118-25, 1998 Feb.
Article in English | MEDLINE | ID: mdl-9472993

ABSTRACT

OBJECTIVE: To determine the extent of side effects during the initial use of nicotine nasal spray for smoking cessation. DESIGN: We performed a one-sample, noncomparative, open-label evaluation of the pattern of use, side effects, relief of withdrawal symptoms, and cotinine levels with nicotine nasal spray. MATERIAL AND METHODS: Adult smokers were recruited to use the nicotine nasal spray for smoking cessation at a dosage of 1 to 2 mg/h. Subjects completed daily diaries, which included an assessment of nicotine withdrawal symptoms, previously reported irritant effects of the nicotine nasal spray, and symptoms of nicotine toxicity. A plasma cotinine level was measured at baseline and at day 7 for calculation of percentage replacement. RESULTS: The mean age of the 50 study subjects was 43.7 years, 46% were women, and the mean baseline smoking rate was 28.5 cigarettes per day. We found an increase in five symptoms (runny nose, nasal irritation, throat irritation, watering eyes, and sneezing) that had been essentially absent before initiation of use of the nicotine nasal spray. All but throat irritation decreased significantly during days 0 through 7 of the study. The mean daily frequency of nicotine nasal spray use for the first week was 15.0 doses. Use of the nasal spray decreased significantly (P<0.001) during the initial 8 weeks of treatment. The mean percentage cotinine replacement for those subjects who were abstinent at day 7 was 38.6%. CONCLUSION: Although nicotine nasal spray causes substantial irritant side effects during the first few days of use, these adverse effects decrease significantly within the first week. Despite these side effects, subjects continued to use the nicotine nasal spray and experienced a high rate of initial abstinence from smoking.


Subject(s)
Nasal Mucosa/drug effects , Nicotine/administration & dosage , Nicotine/adverse effects , Nicotinic Agonists/administration & dosage , Nicotinic Agonists/adverse effects , Smoking Cessation/methods , Substance Withdrawal Syndrome/etiology , Administration, Inhalation , Adult , Aged , Body Weight , Cotinine/blood , Female , Humans , Linear Models , Male , Middle Aged , Severity of Illness Index , Time Factors , Treatment Outcome
19.
J Gen Intern Med ; 13(1): 9-15, 1998 Jan.
Article in English | MEDLINE | ID: mdl-9462489

ABSTRACT

OBJECTIVE: Examine weight change in subjects receiving variable doses of transdermal nicotine replacement for smoking cessation. DESIGN: Randomized, double-blind clinical trial. SETTING: One-week inpatient treatment with outpatient follow-up through 1 year. INTERVENTION: This report examines weight change after smoking cessation for 70 subjects randomized to placebo or to 11, 22, or 44 mg/d doses of transdermal nicotine. The study included 1 week of intensive inpatient treatment for nicotine dependence with active patch therapy continuing for another 7 weeks. Counseling sessions were provided weekly for the 8 weeks of patch therapy and with long-term follow-up visits at 3, 6, 9, and 12 months. MEASUREMENTS AND MAIN RESULTS: Forty-two subjects were confirmed biochemically (i.e., by expired carbon monoxide) to be nonsmokers at all weekly visits during patch therapy. Their 8-week weight change from baseline was 3.0 +/- 2.0 kg. For these subjects, 8-week weight change was found to be negatively correlated with percentage of cotinine replacement (r = -.38, p = .012) and positively correlated with baseline weight (r = .48, p = .001), and age (r = .35, p = .025). Men had higher (p = .003) 8-week weight gain (4.0 +/- 1.8 kg) than women (2.1 +/- 1.7 kg). Of the 21 subjects who abstained continuously for the entire year, 20 had their weight measured at 1-year follow-up. Among these 20 subjects, 1-year weight change was not found to be associated with gender, baseline weight, baseline smoking rate, total dose of transdermal nicotine, or average percentage of cotinine replacement during the 8 weeks of patch therapy. CONCLUSIONS: This study suggests that higher replacement levels of nicotine may delay postcessation weight gain. This effect is consistent for both men and women. We could not identify any factors that predict weight change with long-term abstinence from smoking.


Subject(s)
Nicotine/therapeutic use , Nicotinic Agonists/therapeutic use , Smoking Cessation/methods , Tobacco Use Disorder/physiopathology , Weight Gain/physiology , Administration, Cutaneous , Dose-Response Relationship, Drug , Double-Blind Method , Female , Follow-Up Studies , Humans , Male , Middle Aged , Nicotine/administration & dosage , Nicotinic Agonists/administration & dosage , Tobacco Use Disorder/drug therapy , Treatment Outcome , Weight Gain/drug effects
20.
Tob Control ; 6(3): 181-7, 1997.
Article in English | MEDLINE | ID: mdl-9396101

ABSTRACT

OBJECTIVE: To examine outcomes and predictors of smoking cessation among elderly patients treated for nicotine dependence. DESIGN: Retrospective analysis of patients aged 65-82 who received a nicotine dependence consultation at the Mayo Medical Center between 1 April 1988 and 30 May 1992. Patients were contacted by telephone by a trained interviewer six months after the consultation and were sent a follow-up survey in August 1993. SETTING: Mayo Medical Center, Rochester, Minnesota, United States. SUBJECTS: A total of 613 patients (310 men, 303 women) with a mean age of 69.0 (SD 3.5) years were seen during the study period. MAIN OUTCOME MEASURES: Point prevalence self-reported smoking status. Patients were considered abstinent if they self-reported not smoking (not even a puff) during the seven days before contact. RESULTS: At six-month follow up, 24.8% of the 613 patients reported abstinence from smoking. On multivariate analysis, smoking abstinence was more likely if patients were hospitalised at the time of the consultation, married to a non-smoking spouse, very motivated to stop smoking, and reported their longest time of previous abstinence to be less than a day or more than a month. The response rate to the mailed follow-up survey was 69.9% (429 of 613). The mean duration of follow up was 40.0 +/- 13.2 months following the consultation. Of the 429 patients, 103 (24.0%) reported abstinence from smoking and 326 (76.0%) were smoking at six-month follow up. Patients who reported abstinence at six months had a higher cessation rate at the last follow up (76.0%) compared with patients who were smoking at six-month follow up (33.0%, P < 0.001). For patients who were not smoking at six months, no factors were found to significantly predict abstinence at last follow up. For patients who were smoking at six months, factors associated with smoking cessation at last follow up were: more than a year as the longest time off cigarettes before the consultation; counsellor rating of less severe nicotine dependence; and older age at first regular smoking. CONCLUSIONS: Several predictors of smoking cessation were identified in this study which may be useful for tailoring smoking interventions for the elderly.


Subject(s)
Aged , Nicotine , Smoking Cessation , Substance-Related Disorders/rehabilitation , Ambulatory Care , Female , Hospitalization , Humans , Male , Prognosis , Retrospective Studies , Severity of Illness Index
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