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Biomedical subjects

J Taylor Hays

Publications and source records attributed to J Taylor Hays.

13 recordsLinked to original sources
PubMed2006

Efficacy of varenicline, an alpha4beta2 nicotinic acetylcholine receptor partial agonist, vs placebo or sustained-release bupropion for smoking cessation: a randomized controlled trial.

CONTEXT: Varenicline, a partial agonist at the alpha4beta2 nicotinic acetylcholine receptor, has the potential to aid smoking cessation by relieving nicotine withdrawal symptoms and reducing the rewarding properties of nicotine. OBJECTIVE: To determine the efficacy and safety of varenicline for smoking cessation compared with placebo or sustained-release bupropion (bupropion SR). DESIGN, SETTING, AND PARTICIPANTS: A randomized, double-blind, placebo-controlled trial conducted between June 2003 and March 2005 at 14 research centers with a 12-week treatment period and follow-up of smoking status to week 52. Of 1413 adult smokers who volunteered for the study, 1027 were enrolled; 65% of randomized participants completed the study. INTERVENTION: Varenicline titrated to 1 mg twice daily (n = 344) or bupropion SR titrated to 150 mg twice daily (n = 342) or placebo (n = 341) for 12 weeks, plus weekly brief smoking cessation counseling. MAIN OUTCOME MEASURES: Continuous abstinence from smoking during the last 4 weeks of treatment (weeks 9-12; primary end point) and through the follow-up period (weeks 9-24 and 9-52). RESULTS: During the last 4 weeks of treatment (weeks 9-12), 43.9% of participants in the varenicline group were continuously abstinent from smoking compared with 17.6% in the placebo group (odds ratio [OR], 3.85; 95% confidence interval [CI], 2.69-5.50; P<.001) and 29.8% in the bupropion SR group (OR, 1.90; 95% CI, 1.38-2.62; P<.001). For weeks 9 through 24, 29.7% of participants in the varenicline group were continuously abstinent compared with 13.2% in the placebo group (OR, 2.83; 95% CI, 1.91-4.19; P<.001) and 20.2% in the bupropion group (OR, 1.69; 95% CI, 1.19-2.42; P = .003). For weeks 9 through 52, 23% of participants in the varenicline group were continuously abstinent compared with 10.3% in the placebo group (OR, 2.66; 95% CI, 1.72-4.11; P<.001) and 14.6% in the bupropion SR group (OR, 1.77; 95% CI, 1.19-2.63; P = .004). Treatment was discontinued due to adverse events by 10.5% of participants in the varenicline group, 12.6% in the bupropion SR group, and 7.3% in the placebo group. The most common adverse event with varenicline was nausea, which occurred in 101 participants (29.4%). CONCLUSIONS: Varenicline is an efficacious, safe, and well-tolerated smoking cessation pharmacotherapy. Varenicline's short-term and long-term efficacy exceeded that of both placebo and bupropion SR. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00143364.

Adult↗
PubMed2005

Nicotine dependence treatment: perceived health status improvement with 1-year continuous smoking abstinence.

BACKGROUND: This study evaluated change in health status as a function of change in smoking status among patients treated clinically for nicotine dependence by comparing overall perceived health status of patients who abstained from cigarettes for 1 year versus those who smoked continuously for 1 year. METHODS: Patients from the Mayo Clinic Nicotine Dependence Center completed a quality-of-life questionnaire (SF-36) following their consultation for nicotine dependence (baseline). At 1 year post-intervention, patients were mailed a follow-up survey that included the SF-36 and items assessing interval smoking history. Study patients included those who self-reported continuous smoking (n=60) and those reporting continuous smoking abstinence for the entire follow-up year (n=146). Data from SF-36 scales at 1 year were analysed using analysis of covariance with baseline scale scores serving as covariates along with baseline characteristics that differed significantly between groups. RESULTS: Compared with those who continued to smoke, patients who were continuously abstinent from smoking for the entire year had more improvement in perceived health status for the SF-36 mental composite scale (P=0.009) and for the SF-36 subscales for role limitations (P<0.001 and P=0.017 for emotional and physical role limitations, respectively), social functioning (P=0.010) and general health (P=0.013). CONCLUSIONS: Smokers treated for nicotine dependence who stop smoking for a year report more improvement in-quality-of-life compared with those who continue to smoke.

Adult↗
PubMed2005

Treating nondepressed smokers with alcohol dependence in sustained full remission: nicotine patch therapy tailored to baseline serum cotinine.

OBJECTIVE: Studies of the efficacy of nicotine replacement therapy among alcoholic smokers have produced mixed findings. Our objective was to examine the smoking abstinence rate in smokers in sustained full remission from alcoholism (as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition) who are receiving nicotine patch therapy with the dose tailored to the baseline serum cotinine concentration. METHOD: In this pharmacological relapse prevention study for 195 smokers with alcohol dependence in sustained full remission, the primary aim was to determine the 7-day point prevalence smoking abstinence rate at the end of 8 weeks of nicotine patch therapy in doses projected to achieve 100% venous replacement. Nicotine patch dose was based on the baseline serum venous cotinine as follows: (1) participants with < or = 200 ng/ml received a patch dose of 22 mg per day; (2) those with 201-300 ng/ml received a 33-mg dose per day, and (3) those with > 300 ng/ml received a 44-mg dose per day. A second (steady-state) serum cotinine concentration was obtained between weeks 2 and 7 to determine the percentage replacement. RESULTS: The point prevalence smoking abstinence rate at the end of the 8 weeks of nicotine patch treatment was 51% (95% confidence interval [CI]: 45%-58%) which is higher than would be expected, and percent replacement of > 80% was achieved in 49 of 85 (58%) tobacco-abstinent subjects. Higher cigarettes per day (odds ratio [OR] = 1.030, 95% CI: 1.004-1.057, p = .023) and a history of depressed mood on the Diagnostic Interview Schedule (OR = 1.940, 95% CI: 1.044-3.605, p = .036) were found to be multivariate independent predictors of smoking at week 8. However, percentage replacement did not predict smoking abstinence. CONCLUSION: We achieved > 80% replacement in most subjects, and there was no evidence of severe nicotine toxicity associated with the tailored dose of nicotine patch therapy.

Administration, Cutaneous↗
PubMed2005

Personality correlates related to tobacco abstinence following treatment.

OBJECTIVE: The five-factor model of personality was used to describe the correlates of smoking abstinence. METHODS: Following treatment in the Mayo Clinic Nicotine Dependence Center, the six month abstinence status was determined by self-report. Sixteen months to 2.4 years following the initial treatment evaluation, and 10 months to 1.9 years after the abstinence status was determined, 475 patients were mailed a Neuroticism, Extraversion, Openness, Five-Factor Inventory questionnaire. Ninety-nine abstinent and 151 smoking patients returned a completed questionnaire. RESULTS: Multivariate analysis showed that low scores on neuroticism and openness were associated with tobacco abstinence. In addition, high scores on neuroticism and low scores on agreeableness and conscientiousness were associated with predictors of poor outcome including greater number of cigarettes smoked per day, initiation of smoking prior to age 18, and a Fagerström Test for Nicotine Dependence score of > or = 6. CONCLUSIONS: Personality characteristics as predictors of smoking abstinence following treatment warrant further investigation in prospective clinical trails. Treatment matching using personality profiling as a guide may be a valuable tool for improving abstinence rates following treatment for nicotine dependence.

Adult↗
PubMed2005

Effects of biochemically confirmed smoking cessation on white blood cell count.

OBJECTIVES: To determine the relationship between white blood cell (WBC) Indices and several baseline variables In a large cohort of healthy smokers and to assess whether these changed after biochemically confirmed smoking cessation. SUBJECTS AND METHODS: The study consisted of 784 healthy smokers enrolled in a trial of sustained-release bupropion, 300 mg/d, for relapse prevention after smoking cessation from 1995 to 1998. Both WBC counts and absolute neutrophil counts (ANCs) were measured at baseline, week 7, and week 52. Smoking status was assessed at weeks 7 and 52 by self-report and biochemically confirmed with expired air carbon monoxide levels. Multivariate analyses compared changes in WBC count and ANC between smokers who did and did not stop smoking, adjusting for treatment group, age, sex, and body mass index. RESULTS: Of 784 smokers enrolled, 461 had biochemically confirmed tobacco abstinence after 7 weeks of bupropion; 429 were randomly assigned to receive continued bupropion therapy or placebo until week 52. Between baseline and week 7, there was a significantly larger decrease in WBC count in continuously abstinent subjects compared with continuing smokers (adjusted P = .03). At 52 weeks, continuously abstinent subjects, compared with continuing smokers, had a greater decline from baseline in WBC count (1.2 +/- 1.9 x 10(9)/L vs 0.1 +/- 1.9 x 10(9)/L; P < .001) and ANC (1.0 +/- 1.6 x 10(9)/L vs 0.2 +/- 1.5 x 10(9)/L; P < .001). CONCLUSION: Biochemically confirmed tobacco abstinence leads to a rapid and sustained decrease in WBC and ANC, possibly reflecting a decrease In an underlying state of tobacco-induced inflammation.

Adult↗
PubMed2004

Body image treatment for weight concerned smokers: a pilot study.

In this pilot project, 41 female weight-concerned smokers were randomly assigned to receive either 12 group sessions of cognitive behavioral therapy for body image concerns or 12 group sessions for weight management. All subjects received open-label bupropion SR, 300 mg daily, exercise instruction, and weekly behavioral counseling for tobacco cessation. At week 12, 7(35%) of the body image participants had 7-day point prevalence smoking abstinence, compared to 5(24%) of the participants in the weight management group (p=0.505).

Adult↗
PubMed2004

Weight concerns among male smokers.

Many smokers perceive that smoking controls their body weight and that stopping smoking leads to weight gain. This study examined characteristics associated with weight concerns in 72 male smokers enrolled in a controlled trial for smoking cessation. Motivation to quit smoking was found to be significantly lower in those with weight concerns (P < .001). Further investigation is needed to enable the tailoring of interventions for weight-concerned male smokers.

Adult↗
PubMed2004

Office-based intervention for tobacco dependence.

A successful office approach for any behavior change, including for tobacco, makes the intervention part of the everyday work of the medical practice. This article recommends how to integrate tobacco treatments efficiently into clinical practice. Specific ways to think systematically about smoking cessation and intervene with patients are discussed. Strategies to implement office-based changes to improve tobacco intervention are then presented.

Directive Counseling↗
PubMed2003

Bupropion for the treatment of tobacco dependence: guidelines for balancing risks and benefits.

Tobacco use, particularly cigarette smoking, is now a global pandemic. The expected morbidity and mortality from smoking-attributable diseases will continue to rise for the next 30 years. In order to reduce this negative impact on worldwide health, effective therapy to aid smoking cessation must be provided to current smokers. Treatment for tobacco dependence involves the combination of behavioural therapies and pharmacological treatment. The most common pharmacological treatments include nicotine replacement therapy and non-nicotine medications, including antidepressants. The antidepressant with the greatest weight of evidence for efficacy in the treatment of tobacco dependence is bupropion. Sustained-release bupropion is approved for the treatment of tobacco dependence in over 50 countries worldwide. The efficacy of bupropion for the treatment of tobacco dependence is attributed to the blockage of dopamine reuptake in the mesolimbic dopaminergic system. This area of the brain is believed to mediate reward for nicotine use and for other drugs of dependence. Randomised, controlled clinical trials have shown that bupropion approximately doubles abstinence rates compared with placebo. In addition, long-term treatment with bupropion may reduce or delay smoking relapse. Bupropion also appears to be effective in the treatment of smokers who have recently relapsed and smokers with other comorbid psychiatric conditions. Bupropion has a good adverse events profile, but the risk exists for serious adverse effects such as seizures. Recent postmarketing surveillance reports have raised safety concerns about bupropion, although no causal relationship between bupropion and the reported serious adverse events or death has been established.

Antidepressive Agents, Second-Generation↗
PubMed2003

Bupropion sustained release for treatment of tobacco dependence.

Tobacco use is a global pandemic. The most common pharmacological treatments of tobacco use and dependence include nicotine replacement therapy and nonnicotine medications. Bupropion sustained release (SR) is the only first-line nonnicotine medication recommended by the US Public Health Service Clinical Practice Guideline. Randomized controlled clinical trials have shown that bupropion SR doubles abstinence rates compared with placebo. Long-term treatment with bupropion SR may reduce or delay smoking relapse. Bupropion SR has an excellent adverse effect profile, although a risk exists for serious adverse effects such as seizures. The risk of serious adverse effects associated with bupropion SR can be reduced by careful selection of patients. This article reviews the evidence of efficacy and common adverse effects of bupropion SR and delineates the clinical characteristics of patients at higher risk for adverse effects when bupropion SR is prescribed for treatment of tobacco use and dependence.

Antidepressive Agents, Second-Generation↗
PubMed2002

Effects of gender on relapse prevention in smokers treated with bupropion SR.

BACKGROUND: Recent data suggest that women smokers respond differently than men to cessation pharmacotherapies, particularly nicotine replacement therapy (NRT). Lower abstinence and higher relapse rates are often reported for women treated with NRT. Gender effects for those treated with non-nicotinic, bupropion-hydrochloride sustained release for relapse prevention have not been studied. METHODS: Data from a multicenter relapse-prevention (RP) trial of bupropion (November 1995-June 1998) were analyzed for gender differences. Men and women smokers (N=784) were treated with open-label bupropion for 7 weeks. Those abstinent at Week 7 (n=432) were enrolled in the double-blind relapse-prevention phase and randomized to placebo or continued bupropion for 45 additional weeks. RESULTS: Differences in point-prevalence abstinence rates between men (61.8%) and women (55.6%) in open-label bupropion (Week 7) were not significant. In the RP-phase Week 52, continuous abstinence rates for men and women were 37.8% and 36.4% (bupropion) and 36.6% and 29.9% (placebo), respectively; point-prevalence abstinence rates for men and women were 54.1% and 55.9% (bupropion) and 42.9% and 41.3% (placebo), respectively. Abstinence rates and time to relapse were superior for both men and women who received longer treatment. Gender differences within treatment groups were not significant. Median time to relapse was equal for men and women within each treatment group: Week 32 for bupropion and Week 20 for placebo. CONCLUSIONS: Our data suggest that bupropion is a promising pharmacotherapy for preventing relapse, particularly for women.

Adult↗
PubMedDate not supplied

Bupropion for pharmacologic relapse prevention to smoking: predictors of outcome.

The aim of this study was to identify predictors of successful relapse prevention in smokers receiving long-term sustained-release bupropion. Smokers (N= 784) who were interested in stopping smoking were enrolled in a 7-week, open-label bupropion phase. Abstinent subjects at the end of treatment and eligible to proceed (N= 429) were randomized to active bupropion or placebo through Week 52 and then followed for an additional year. The best overall predictor of less relapse to smoking was assignment to active bupropion. In aggregate, the results indicate that bupropion can be prescribed to diverse populations of smokers with expected comparable results. There was a medication effect that was independent of any predictor except older age and those who gained no or minimal weight during the open-label phase. Predictors of successful relapse prevention included lower baseline smoking rates, a Fagerström Tolerance Questionnaire score of < 6, and initiation of smoking at an older age. These data should encourage others to perform similar pharmacologic relapse prevention studies with this or other pharmacotherapies.

Adult↗