Behavioral treatment for smokers with a history of alcoholism: predictors of successful outcome.

This study examined baseline predictors associated with smoking abstinence among 205 smokers (113 men, 92 women) with a past history of alcoholism. Their mean age was 41.8 years, and 93% were Caucasian. Participants were randomly assigned to standard treatment (ST), behavioral counseling plus exercise (BEX), or behavioral counseling plus nicotine gum (BNIC). Factors multivariately associated with point-prevalence smoking abstinence at posttreatment (1 week after target quit date) were a longer duration of prior smoking abstinence and an interaction between treatment group and having an active 12-step sponsor. ST was more effective for those with an active sponsor, whereas both BEX and BNIC were more effective for those without an active sponsor. At 1-year follow-up, independent predictors of point-prevalence smoking abstinence were a lower Fagerström Tolerance Questionnaire score (K. O. Fagerström, 1978) and fewer years of smoking.

Sustained-release bupropion for pharmacologic relapse prevention after smoking cessation. a randomized, controlled trial.

BACKGROUND: Smoking relapse is common after successful pharmacologic treatment for smoking cessation. No previous studies have examined long-term drug therapy used expressly for prevention of smoking relapse. OBJECTIVE: To evaluate the efficacy of bupropion to prevent smoking relapse. DESIGN: Randomized, placebo-controlled trial. PARTICIPANTS: 784 healthy community volunteers who were motivated to quit smoking and who smoked at least 15 cigarettes per day. INTERVENTION: The participants received open-label, sustained-release bupropion, 300 mg/d, for 7 weeks. Participants who were abstinent throughout week 7 of open-label treatment were randomly assigned to receive bupropion, 300 mg/d, or placebo for 45 weeks and were subsequently followed for an additional year after the conclusion of the medication phase. Participants were briefly counseled at all follow-up visits. At the end of open-label bupropion treatment, 461 of 784 participants (58.8%) were abstinent from smoking. MEASUREMENT: Self-reported abstinence was confirmed by an expired air carbon monoxide concentration of 10 parts per million or less. RESULTS: The point prevalence of smoking abstinence was significantly higher in the bupropion group than in the placebo group at the end (week 52) of drug therapy (55.1% vs. 42.3%, respectively; P = 0.008) and at week 78 (47.7% vs. 37.7%; P = 0.034) but did not differ at the final (week 104) follow-up visit (41.6% vs. 40.0%). The median time to relapse was significantly greater for bupropion recipients than for placebo recipients (156 days vs. 65 days; P = 0.021). The continuous abstinence rate was higher in the bupropion group than in the placebo group at study week 24 (17 weeks after randomization) (52.3% vs. 42.3%; P = 0.037) but did not differ between groups after week 24. Weight gain was significantly less in the bupropion group than in the placebo group at study weeks 52 (3.8 kg vs. 5.6 kg; P = 0.002) and 104 (4.1 kg vs. 5.4 kg; P = 0.016). CONCLUSIONS: In persons who stopped smoking with 7 weeks of bupropion treatment, sustained-release bupropion for 12 months delayed smoking relapse and resulted in less weight gain.

Tobacco use outcomes of adolescents treated clinically for nicotine dependence.

OBJECTIVE: To evaluate the tobacco use outcomes and baseline characteristics of adolescents treated for nicotine dependence. DESIGN: Retrospective cohort study. SETTING: Mayo Clinic Nicotine Dependence Center, Rochester, Minn. PATIENTS: Ninety-six adolescents (60 boys, 36 girls) receiving clinical services for treatment of nicotine dependence between January 1, 1988, and November 30, 1997. Their mean age was 15.6 years (range, 11-17 years), and 91.7% were white. INTERVENTION: The Nicotine Dependence Center intervention involves a 45-minute consultation with a nicotine dependence counselor. A treatment plan individualized to the patient's needs is then developed. Telephone follow-up is conducted at 6 and 12 months. As part of this study, a long-term follow-up was conducted by telephone at a mean of 5.3 years (range, 1.6-10.6 years) following the intervention. MAIN OUTCOME MEASURES: Self-reported 7-day point-prevalence abstinence from tobacco at 6 and 12 months, and 30-day point-prevalence tobacco abstinence at the long-term follow-up. RESULTS: The tobacco abstinence rates were 17.7% (17/96 patients) at 6 months, 7.3% (7/96 patients) at 12 months, and 11.5% (11/96 patients) at the long-term follow-up. A high proportion of the sample had smoking-related medical morbidity and psychiatric diagnoses documented in the medical record prior to or at the time of the intervention. CONCLUSIONS: Adolescents utilize the medical community to seek treatment for nicotine dependence. The 6-month tobacco abstinence rate is higher than the estimates of the natural history of smoking cessation in adolescents. Medical and psychiatric diagnoses are common in this population.

Anticipating mechanical ventilation in Guillain-Barré syndrome.

CONTEXT: The combination of multiple clinical factors culminates in neuromuscular respiratory failure in up to 30% of the patients with Guillain-Barré syndrome (GBS). Although guidelines exist as to when to proceed with intubation, early indicators of subsequent progression to respiratory failure have not been established. OBJECTIVES: To identify clinical and respiratory features associated with progression to respiratory failure and to examine patterns of respiratory decline in patients with severe GBS. DESIGN: Retrospective survey. SETTING: Tertiary care hospital. PATIENTS: One hundred fourteen consecutive patients with severe GBS admitted to the intensive care unit between January 1, 1976, and December 31, 1996. MAIN OUTCOME MEASURES: Early markers of impending respiratory failure, requirement for mechanical ventilation, and patterns of respiratory decline. METHODS: The clinical and electrophysiologic features of 60 patients receiving mechanical ventilation were compared with 54 patients with severe GBS who did not receive mechanical ventilation. Daily preventilation maximal inspiratory and maximal expiratory respiratory pressures and vital capacity were analyzed. Multivariate predictors of the necessity for mechanical ventilation were assessed using logistic regression analysis. RESULTS: Progression to mechanical ventilation was highly likely to occur in those patients with rapid disease progression, bulbar dysfunction, bilateral facial weakness, or dysautonomia. Factors associated with progression to respiratory failure included vital capacity of less than 20 mL/kg, maximal inspiratory pressure less than 30 cm H(2)O, maximal expiratory pressure less than 40 cm H(2)O or a reduction of more than 30% in vital capacity, maximal inspiratory pressure, or maximal expiratory pressure. No clinical features predicted the pattern of respiratory decline; however, serial measurements of pulmonary function tests allowed detection of those at risk for respiratory failure. CONCLUSIONS: While inherently unpredictable, the course of patients with severe GBS can, to some extent, be predicted on the basis of clinical information and simple bedside tests of respiratory function. These data may be used in the decisions regarding admission to the intensive care unit and preparation for elective intubation.

Relationship of mood disturbance to cigarette smoking status among 252 patients with a current mood disorder.

BACKGROUND: The relationship between cigarette smoking and mood has received increasing attention. This retrospective study evaluated the relationship between mood disturbance and cigarette smoking status among patients with a current mood disorder. The association between level of nicotine dependence and severity of mood disturbance was also evaluated among current smokers. METHOD: Retrospective data for 252 patients (63.5% male, 85.0% white) admitted for treatment of a mood disorder at the San Diego Veteran Affairs Mental Health Clinical Research Center between November 1988 and June 1997 were studied. All current cigarette smokers at admission (N = 126) were matched with nonsmokers (N = 126) on the primary DSM-IV Axis I mood disorder diagnosis, admission status (inpatient or outpatient), gender, age (+/- 5 years), and ethnicity. The Hamilton Rating Scale for Depression (HAM-D), the Beck Depression Inventory, and the Profile of Mood States (POMS) were administered to patients on admission. Conditional logistic regression analysis for matched sets with a backward elimination was used to identify factors independently predictive of current smoking status. RESULTS: A greater number of cups of coffee consumed per day (p = .002), a history of alcoholism (p = .004), and higher POMS fatigue subscale scores (p = .007) were predictive of current smoking status. Among current smokers, the HAM-D terminal insomnia item was positively associated with mean number of cigarettes smoked per day (p = .012). CONCLUSION: Cigarette smoking should be addressed in the treatment of patients with a current mood disorder. Smokers experience greater levels of fatigue than nonsmokers. In addition, higher cigarette consumption levels are associated with mild-to-severe symptoms of terminal insomnia.

Residential (inpatient) treatment compared with outpatient treatment for nicotine dependence.

OBJECTIVE: To compare smoking abstinence outcomes between smokers treated in a residential (inpatient) program and those treated in an outpatient program to determine if residential treatment was superior to outpatient treatment in smokers with moderate to severe nicotine dependence. PATIENTS AND METHODS: Patients treated in the residential nicotine dependence program at the Mayo Clinic, Rochester, Minn., between May 1, 1992, and January 31, 1996, were selected for this study. Each patient in the residential treatment group (n=146) was matched to 2 patients who received an outpatient nicotine dependence consultation by a trained counselor (n=292). Each patient was matched on age, sex, year seen, number of cigarettes smoked per day, longest previous abstinence, education, and marital status. Abstinence at 6 and 12 months was determined by self-report. For the purposes of analysis, each patient with missing outcome data was considered to be smoking. RESULTS: The 6-month abstinence rates for the residential group compared with the outpatient group were 45% and 26%, respectively (P<.001), and the 12-month abstinence rates were 45% and 23%, respectively (P<.001). After adjusting for matching variables that were not exactly matched (age, baseline number of cigarettes smoked per day, and longest previous abstinence) and the baseline variables, including education, age when started smoking, and degree of nicotine dependence, there was a significant effect of residential treatment on 6- and 12-month abstinence rates (P<.001). Odds ratio of 6-month abstinence in the residential group was 2.74 (95% confidence interval, 1.60-4.71; P<.001) and at 12 months was 3.03 (95% confidence interval, 1.74-5.27; P<.001). CONCLUSION: Residential treatment for tobacco dependence is superior to outpatient treatment in some smokers who are moderately to severely nicotine dependent.

A free smoking intervention clinic initiated by medical students.

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.

Effect of current tobacco use and history of an alcohol problem on health status in hospitalized patients.

This prospective study assessed the relationship between current tobacco use and history of an alcohol problem to health status in hospitalized patients. Factors associated with current tobacco use and history of an alcohol problem were also evaluated. Data were collected using a self-administered survey distributed by nursing staff to adult inpatients registered on April 27, 1994 at the Mayo Clinic, Rochester, Minnesota affiliated hospitals. Respondents (N = 589, 45% female) were classified into 4 subgroups based on current tobacco use status and history of an alcohol problem: (a) current tobacco use only (n = 94, 16%); (b) history of an alcohol problem only (n = 30, 5%); (c) both (n = 27, 5%); or (d) neither (n = 438, 74%). Patients with both current tobacco use and an alcohol problem history reported markedly lower scores on health status measures of general and mental health compared to the other three subgroups. Moreover, current tobacco use and history of an alcohol problem were each associated with increased psychological distress. Current tobacco use was predictive of a history of an alcohol problem and vice versa.

Accuracy of patient prediction of allergy skin test results.

BACKGROUND: The ability of patients to self-diagnose allergy is unknown. OBJECTIVE: To estimate the ability of patients to correctly predict the results of allergy skin tests. METHODS: We conducted a structured interview of 86 patients with chronic rhinitis or asthma undergoing aeroallergen skin tests. We asked, "Do you expect the skin tests to be positive or negative?" and "What do you expect the allergy tests to be positive for?" Responses to these questions were correlated with the results of aeroallergen skin tests. Skin tests were performed using the prick technique and included cat, grass pollen, tree pollen, weed pollen, dust mites, and molds. RESULTS: Seventy-three participants provided usable responses. Of those with a positive skin test, the number (percentage) of participants who predicted correctly was 10/18 (56%) for cat, 4/14 (29%) for tree, 7/26 (27%) for weeds, 5/23 (22%) for dust mite, 2/12 (17%) for grass, and 1/8 (12%) for mold. Of those with a negative skin test, the number (percentage) of participants who predicted correctly was 47/50 (94%) for dust mite, 51/59 (86%) for trees, 56/65 (86%) for mold, 52/61 (85%) for grass, 45/55 (82%) for cat, and 38/47 (81%) for weeds. CONCLUSIONS: (1) Patients have limited ability to correctly predict positive skin tests to aeroallergen. (2) Patients are able to predict negative skin tests with reasonable accuracy. (3) "What do you think you are allergic to?" may be a good screening question for patients with asthma and rhinitis.

Carbidopa/levodopa for smoking cessation: a pilot study with negative results.

The mesolimbic dopamine system is thought to be a critical substrate for drugs of addiction including nicotine. Since dopamine may play a critical role in mediating the reinforcing effects of nicotine, we hypothesized that administering levodopa in its therapeutic form (carbidopa/levodopa) might be effective for smoking cessation by replacing the effects of dopamine that smokers may seek during smoking. A pilot open-label study using carbidopa/levodopa for smokers wanting to stop smoking was carried out at the Mayo Clinic Nicotine Research Center, Rochester, MN. The dosing schedule was one tablet TID for 1 week, 1 1/2 tablets TID for 1 week, then two tablets TID for 6 weeks. Each tablet contained 25 mg of carbidopa and 100 mg of levodopa. The subjects were 40 adult smokers smoking > or = 20 cigarettes per day for 3 or more years. Self-reported abstinence from smoking was confirmed by expired air CO level of < or = 8 ppm. Nicotine withdrawal symptoms were assessed at baseline and daily during the medication phase. Smoking abstinence rates and withdrawal symptom relief were compared to the placebo (n = 153) arm of a previously reported bupropion smoking cessation trial. The biochemically confirmed, 7-day point-prevalence smoking abstinence rate at the end of carbidopa/levodopa treatment was 20.0% versus 19.0% for the placebo group (p > 0.10), and 12.5% of the carbidopa/levodopa group were abstinent versus 15.7% for the placebo group (p > 0.10) at 6 months. Subjects from both studies had significant increases in withdrawal scores from baseline, but there were no significant differences between the two groups at any time period. We found no differences in smoking abstinence rates or nicotine withdrawal symptom relief in smokers receiving carbidopa/levodopa compared to placebo. Despite the theoretical reasons why carbidopa/levodopa might be effective as a pharmacological adjunct in treating smokers, it was not observed in this group of smokers at this dose.

Long-term outcome in patients with Guillain-Barré syndrome requiring mechanical ventilation.

OBJECTIVE: To analyze long-term recovery and predictors of outcome in patients with Guillain-Barré syndrome (GBS) requiring mechanical ventilation. METHODS: The clinical and electrophysiologic data of 114 patients with GBS admitted to the intensive care unit between 1976 and 1996 (60 mechanically ventilated, 54 nonventilated) were reviewed. Functional disability and predictors of outcome were determined at 1 year and at maximal recovery using the Hughes scale. Good outcome was defined as ability to ambulate without assistance; poor outcome was defined as inability to ambulate independently. RESULTS: Mechanical ventilation was required in 81% of patients with a poor outcome. Mortality was 20% in patients ventilated for GBS. However, ventilated patients who survived did well, with 79% eventually regaining independent ambulation. Nineteen percent of patients improved at least one functional grade beyond 1 year. Univariate predictors of poor maximal recovery in ventilated GBS patients were increased age (p < 0.001)), upper limb paralysis (p = 0.004), duration of ventilation (p = 0.006), and delay of more than 2 days to transfer to a tertiary center (p < 0.001). However, only age (OR 1.99, p = 0.004) and delayed transfer (OR 19.8, p = 0.002) were independently predictive of poor outcome on multivariate analysis. CONCLUSION: Mechanically ventilated patients constitute the majority of GBS patients with a poor outcome, and mortality remains substantial in this subgroup (20%). Although recovery from severe GBS may be prolonged, most survivors regain independent ambulation.

Nicotine patch therapy in 101 adolescent smokers: efficacy, withdrawal symptom relief, and carbon monoxide and plasma cotinine levels.

OBJECTIVES: To determine the efficacy of nicotine patch therapy in adolescents who want to stop smoking and to assess biochemical markers of smoking and nicotine intake. DESIGN: Nonrandomized, open-label trial using a 15 mg/16 h patch. SETTING: Two midwestern cities. SUBJECTS: One hundred one adolescents aged 13 through 17 years smoking at least 10 cigarettes per day (cpd). INTERVENTION: Six weeks of nicotine patch therapy and follow-up visits at 12 weeks and 6 months. MAIN OUTCOME MEASURES: Self-reported smoking abstinence verified by expired-air carbon monoxide (CO) level of no more than 8 ppm, nicotine withdrawal symptoms, and plasma cotinine level. RESULTS: Forty-one participants were female (mean [+/- SD] age, 16.5 [+/- 1.1] years). Median baseline smoking rate was 20.0 cpd (range, 10-40 cpd). Biochemically confirmed point prevalence smoking abstinence was 10.9% (11/101) at 6 weeks and 5.0% (5/101) at 6 months. The mean (+/- SD) plasma cotinine level at baseline was 1510.9 +/- 732.7 nmol/L; for nonsmoking subjects at weeks 3 and 6, 607.8 +/- 386.2 and 710.0 +/- 772.5 nmol/L, respectively. Plasma cotinine levels were correlated with CO levels at baseline (r = 0.27; P = .006), week 3 (r = 0.34; P = .004), and week 6 (r = 0.26; P = .03) and with mean cigarettes smoked per day during weeks 3 (r = 0.24; P = .04) and 6 (r = 0.30; P = .02). Mean smoking rates decreased significantly during the study, an effect that lessened at 12 weeks and 6 months. CONCLUSIONS: Nicotine patch therapy plus minimal behavioral intervention does not appear to be effective for treatment of adolescent smokers. Plasma cotinine and CO levels appear to be valid measures of smoking rates during the cessation process, but not at baseline. Smoking rates were reduced throughout the study. Additional pharmacological and behavioral treatments should be considered in adolescent smokers.

Does smoking reduction result in reduction of biomarkers associated with harm? A pilot study using a nicotine inhaler.

The aim of the study was to determine if smoking reduction using a nicotine inhaler in heavy cigarette smokers who wanted to reduce but not stop smoking results in decreased levels of known biomarkers of harm. The study design was a one-sample within-subject comparative open-label study of 23 (10 male and 13 female) subjects using a nicotine inhaler to reduce smoking, with follow-up at 24 weeks. A structured protocol was used with a smoking-reduction schedule from 40 or more cigarettes per day to 10 cigarettes per day by week 9. Behavioral counseling was provided by a research assistant and ad lib use of the nicotine inhaler for 12 weeks was permitted. Blood thiocyanate, cotinine, 4-aminobiphenyl hemoglobin adducts; urine NNAL and NNAL-glucuronide; and expired air carbon monoxide were measured. On average, the subjects were able to reduce their smoking by over 50% at week 12, but only two were able to reduce to 10 cigarettes per day. The reported reduction in smoking was not associated with a consistent reduction in the biomarkers. There was no reduction in the NNAL, 4-aminobiphenyl hemoglobin adducts nor carbon monoxide levels of expired air. There was a significant reduction of NNAL-glucuronide and the sum of NNAL and NNAL-glucuronide but only at week 24. Thiocyanate levels increased. Before widely promoting harm reduction as a treatment strategy for heavy smokers, more research needs to be performed to prove conclusively that such smokers who want to reduce but not stop can actually reduce and maintain their smoking rate at a level which is likely to reduce harm. It also needs to be determined whether a reduction in the smoking rate translates into reduction of harm. At the present, for heavy smokers, an abstinence approach seems to be more scientifically sound.

Over-the-counter nicotine patch therapy for smoking cessation: results from randomized, double-blind, placebo-controlled, and open label trials.

OBJECTIVES: The purpose of this study was to determine the efficacy and safety of the nicotine patch for smoking cessation in an over-the-counter environment. The years of study were 1994 to 1995. METHODS: Parallel 6-week trials were conducted: a placebo-controlled trial of no-cost 22-mg, 24-hour nicotine patch therapy and an open label trial of the same therapy with patches purchased by subjects. Participants (n = 958) were 18 years or older, had smoked at least 15 cigarettes daily for at least 6 months, and were enrolled at 3 study sites. The main outcome measure was self-reported smoking abstinence confirmed by expired carbon monoxide measurements. RESULTS: Smoking cessation rates in the placebo-controlled trial were 16.8% and 9.6% at week 6 and 8.7% and 4.3% at week 24 for the active patch and placebo groups, respectively. Smoking cessation rates in the open label-pay trial were 19.0% and 10.8% at weeks 6 and 24, respectively. A slight increase in adverse cardiovascular events was noted only in the open label-pay group in comparison with the placebo group. CONCLUSIONS: In an over-the-counter environment, the 22-mg, 24-hour nicotine patch is effective and safe for smoking cessation treatment.

A randomized trial of naltrexone for smoking cessation.

AIMS: To evaluate the efficacy and safety of orally administered naltrexone, alone or in combination with nicotine patches, as a treatment for cigarette smoking. DESIGN: Randomized, partially-blinded, 2 x 2 factorial trial using naltrexone (active vs. placebo) and nicotine patches (active vs. none). PARTICIPANTS: One hundred cigarette smokers. INTERVENTION: Twelve weeks of either placebo-only, naltrexone-only, placebo with nicotine patches or naltrexone with nicotine patches. The naltrexone dose was 50 mg taken once daily, and the nicotine patch dose was 21 mg/24-hour for the first 8 weeks and 14 mg/24-hour for the remaining 4 weeks. Brief behavioral intervention was provided at each visit. MEASUREMENTS: One-week point-prevalence smoking abstinence rates confirmed by an expired air carbon monoxide level of 8 parts per million (ppm) or less, daily cigarette smoking and cigarette craving. FINDINGS: At the end of treatment, there was no effect of naltrexone on smoking abstinence. The smoking abstinence rates were 19% and 22% for the placebo only and naltrexone only treatment groups, respectively, and 48% and 46% for the placebo with nicotine patch and naltrexone with nicotine patch groups, respectively. However, the effect of the nicotine patch at this time was significant (p = 0.006), but not at the 6-month follow-up. No significant effect of naltrexone was observed on daily cigarette smoking on cigarette craving during the study. CONCLUSIONS: The opioid antagonist naltrexone was not found to be effective for smoking cessation and had no significant effect on daily cigarette consumption or craving. The results of the present study provide no support for the use of naltrexone, alone or in combination with nicotine patches, as a therapeutic treatment for smoking cessation.

Temporal effects of nicotine nasal spray and gum on nicotine withdrawal symptoms.

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.

Weight change after smoking cessation using variable doses of transdermal nicotine replacement.

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.

Predictors of smoking cessation among elderly smokers treated for nicotine dependence.

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.

Effects of 24-hr nicotine replacement on sleep and daytime activity during smoking cessation.

BACKGROUND: This study uses wrist actigrapy to assess the effects of 24-hr transdermal nicotine replacement on the sleep and daytime activity of smokers during smoking cessation. METHODS: Seventy-one subjects grouped as light (n = 23), moderate (n = 24), or heavy (n = 24) smokers were randomly assigned to placebo or 11, 22, or 44 mg/day doses of transdermal nicotine for 1 week of intensive inpatient treatment of nicotine dependence. Outpatient patch therapy continued for 7 weeks following the inpatient stay. Those initially on placebo were randomly assigned to 11 or 22 mg/day, and those initially on 44 mg/day were reduced to 22 mg/day at Week 4. RESULTS: There was a significant decrease in daytime wrist activity during patch therapy and the 1st week off patch therapy. These changes in daytime wrist activity were positively correlated with percentage of nicotine and cotinine replacement. No changes from baseline in sleep (sleep efficiency or wrist activity) were detected, nor were there differences in sleep among the four patch doses. CONCLUSIONS: Using wrist actigraphy, this study failed to show any disturbing effects of 24-hr high-dose nicotine replacement on sleep. Lower levels of nicotine replacement were associated with a decrease from baseline in daytime wrist activity.