Bupropion SR for relapse prevention: a "slips-allowed" analysis

OBJECTIVE: To assess the efficacy of bupropion SR on smoking abstinence using a "slips allowed" analysis. METHODS: Retrospective analysis, which did not consider brief episodic "slips" as a return to regular smoking, of data from a multicenter, randomized, doubleblind, placebo-controlled relapse prevention study. RESULTS: Using a slips-allowed analysis, median time to relapse on bupropion SR was 65 weeks versus 30 weeks on placebo. This is compared to 32 and 20 weeks, respectively, using a traditional analysis not allowing for slips. CONCLUSION: Bupropion SR is efficacious for the prevention of smoking relapse. A slips-allowed analysis may provide a more clinically relevant assessment of efficacy.     

Varenicline versus bupropion SR or placebo for smoking cessation: a pooled analysis

Objectives: To evaluate varenicline's efficacy for smoking cessation versus bupropion SR and placebo and to explore whether factors typically predictive of abstinence influence varenicline's efficacy versus placebo, as measured by the week 9-12 continuous abstinence rate (CAR9-12). Methods: Smokers in 2 randomized, placebo-controlled trials received varenicline 1 mg BID (n=696), bupropion SR 150 mg BID (n=671), or placebo (n=685) for 12 weeks. Nontreatment followup lasted 40 weeks. Results: CAR(9-12) was greater for varenicline (44.0%) versus bupropion SR (29.7%; P<0.0001) and placebo (17.7%; P<0.0001). CAR(9-12) for varenicline versus placebo was not affected by age, gender, or nicotine dependence level. Conclusions: Varenicline was more efficacious than bupropion SR or placebo. Varenicline's efficacy versus placebo was not influenced by factors predictive of abstinence.     

Bupropion SR enhances weight loss: a 48-week double-blind,placebo- controlled trial

OBJECTIVE: To critically examine the efficacy of bupropion SR for weight loss. RESEARCH METHODS AND PROCEDURES: This 24-week multicenter, double-blind, placebo-controlled study randomized obese adults to placebo, bupropion SR 300, or 400 mg/d. Subjects were counseled on energy-restricted diets, meal replacements, and exercise. During a 24-week extension, placebo subjects were randomized to bupropion SR 300 or 400 mg/d in a double-blinded manner. RESULTS: Of 327 subjects enrolled, 227 completed 24 weeks; 192 completed 48 weeks. Percentage losses of initial body weight for subjects completing 24 weeks were 5.0%, 7.2%, and 10.1% for placebo, bupropion SR 300, and 400 mg/d, respectively. Compared with placebo, net weight losses were 2.2% (p = 0.0468) and 5.1% (p < 0.0001) for bupropion SR 300 and 400 mg/d, respectively. The percentages of subjects who lost >or=5% of initial body weight were 46%, 59%, and 83% (p vs. placebo < 0.0001) for placebo, bupropion SR 300, and 400 mg/d, respectively; weight losses of >or=10% were 20%, 33%, and 46% (p vs. placebo = 0.0008) for placebo, bupropion SR 300, and 400 mg/d, respectively. Withdrawals, changes in pulse and blood pressure did not differ significantly from placebo at 24 weeks. Subjects who completed 48 weeks maintained mean losses of initial body weight of 7.5% and 8.6% for bupropion SR 300 and 400 mg/d, respectively. DISCUSSION: Bupropion SR 300 and 400 mg/d were well-tolerated by obese adults and were associated with a 24-week weight loss of 7.2% and 10.1% and sustained weight losses at 48 weeks.     

Bupropion SR vs. placebo for weight loss in obese patients with depressive symptoms

OBJECTIVE: This randomized, double-blind, placebo-controlled study evaluated the efficacy and tolerability of bupropion sustained-release (bupropion SR) in reducing weight and depressive symptoms in obese adults. RESEARCH METHODS AND PROCEDURES: Obese adults (body mass index, 30 to 44 kg/m(2)) not currently meeting criteria for major depression but with depressive symptoms (Beck Depression Inventory score 10-30) received bupropion SR 300 mg/d or placebo for 26 weeks with a 500 kcal/d-deficit diet. Patients who lost <5% of baseline weight at week 12 had bupropion SR dosage or placebo increased to 400 mg/d in a blinded fashion. RESULTS: The bupropion SR group (n = 193) lost an average of 4.4 kg (4.6% of baseline weight) vs. 1.7 kg (1.8% of baseline weight) on placebo (n = 191, p < 0.001, last-observation-carried-forward analysis). More patients in the bupropion SR group than in the placebo group (40% vs. 16% of intent-to-treat sample, 50% vs. 28% of completers, respectively) lost at least 5% of baseline weight (p < 0.05 at week 4, p < 0.001 at weeks 6 to 26). The percentage of patients reporting > or =50% decrease in depressive symptoms did not differ between groups, but depressive symptoms improved more with bupropion SR than with placebo among patients with a history of major depression (p < 0.05, weeks 4 to 26). In the sample as a whole, improvement in depressive symptoms was related to weight loss of > or =5% regardless of treatment (p < 0.0001). Bupropion SR was well-tolerated. DISCUSSION: Bupropion SR in combination with a 500 kcal/d-deficit diet facilitated weight loss. Weight loss of > or =5% may improve mood in obese patients with depressive symptoms.     

Bupropion sustained release (SR) for the treatment of hypoactive sexual desire disorder (HSDD) in nondepressed women

This article describes the results of the first report of bupropion sustained release (SR) in nondepressed females with hypoactive sexual desire disorder (HSDD). Eligible females entered a 4-week, single-blind, placebo baseline phase. Subjects, all of whom did not respond to placebo, continued in a single-blind active treatment phase where they received bupropion SR for up to 8 additional weeks. We assessed HSDD by using investigator ratings of sexual desire and sexual functioning. Of the 51 evaluable subjects who entered the active treatment phase, 29% responded to treatment with bupropion SR. Bupropion SR was generally well tolerated. Pending the results of further study, bupropion SR may offer a treatment option for women with HSDD.     

Return on Investment of Different Combinations of Bupropion SR Dose and Behavioral Treatment for Smoking Cessation in a Health Care Setting: An Employer''s Perspective

The net benefit (i.e., benefits minus costs) of sustained-release (SR) bupropion for smoking cessation from an employer's perspective has previously been evaluated in clinical trials including frequent, in-person behavioral counseling and manufacturer recommended dosing but not in actual practice settings and lower dosing. OBJECTIVES: The objective of this research was to determine the return on investment (ROI) and internal rate of return (IRR) from an employer's perspective of two dosing schedules of bupropion SR in combination with behavioral interventions of minimal intensity (tailored mailings, TM) or moderate intensity (proactive telephone calls, PTC) in an actual practice setting. METHODS: An open-label, randomized trial with 1-year follow-up was conducted in a large health system (Group Health Cooperative) based in Seattle, WA. Participants included 1524 adult smokers interested in quitting smoking. Participants were randomly assigned to receive 150 mg of bupropion SR daily and PTC (n=382), 150 mg of bupropion SR daily and TM (n=381), 300 mg of bupropion SR daily and PTC (n=383) or 300 mg of bupropion SR daily and TM (n=378). Sufficient medications for 8 weeks of dosing were provided to patients. The primary outcome measure of the field trial was self-reported point-prevalence 7-day nonsmoking status at 12 months, and the primary outcome measures of the economic analysis were employer net benefit, employer ROI, and the ROI-associated IRR using 2002 dollars. Results: Using net benefit, the 300-mg/PTC and the 150-mg/PTC treatments were approximately equally preferred. Using ROI or IRR, both the 150-mg/TM and 150-mg/PTC treatments were about equally preferred, with IRR values of 31.7% and 31.4%, respectively. Under a pessimistic scenario regarding effectiveness and costs, 150 mg/PTC became more cost-effective than 150 mg/TM, and employer IRR for 150 mg/PTC was 13%. Under an optimistic scenario IRR exceeded 45% for all treatments. CONCLUSIONS: These results suggest that employers can receive competitive returns on investment from sponsoring smoking cessation programs, that 150 mg of bupropion doses yield better returns than 300-mg doses, and that PTC treatments should be preferred to TM if smoking cessation rates in the targeted employee population are lower than those in the study population.     

Bupropion SR and smoking cessation in actual practice: methods for recruitment,screening, and exclusion for a field trial in a managed-care setting

BACKGROUND: Little is known about the effectiveness of bupropion SR for smoking cessation outside the context of clinical efficacy trials, where in-person screening and treatment occur at a higher level than provided in a typical health care system. This article describes the methods for recruitment, screening for exclusions, and resulting sample in a field trial of bupropion SR undertaken in a managed-care setting. METHODS: A total of 2979 telephone interviews were conducted to screen and identify eligible volunteers using a detailed protocol that allowed for consultation with study physicians when necessary. The volunteers' primary care physicians were given the option to override their eligibility, and pharmacy databases were used to verify medication reporting. RESULTS: A total of 1909 (64%) volunteers were considered eligible for the study. The most common reason for exclusion was use of contraindicated medications (32%), followed by recent use of one of the behavioral cessation programs (14%), brain injury that reduced seizure threshold (14%), current depression (14%), and high levels of alcohol use (13%). CONCLUSIONS: The methods used in this field trial show that it is possible to enroll subjects in an effectiveness trial that is successful from the standpoint of the consumer, provider, and health care system.     

Bupropion for weight loss: an investigation of efficacy and tolerability in overweight and obese women

OBJECTIVE: On the basis of the clinical observations that bupropion facilitated weight loss, we investigated the efficacy and tolerability of this drug in overweight and obese adult women. RESEARCH METHODS AND PROCEDURES: A total of 50 overweight and obese (body mass index: 28.0 to 52.6 kg/m(2)) women were included. The core component of the study was a randomized, double-blind, placebo-controlled comparison for 8 weeks. Bupropion or placebo was started at 100 mg/d with gradual dose increase to a maximum of 200 mg twice daily. All subjects were prescribed a 1600 kcal/d balanced diet and compliance was monitored with food diaries. Responders continued the same treatment in a double-blind manner for an additional 16 weeks to a total of 24 weeks. There was additional single-blind follow-up treatment for a total of 2 years. RESULTS: Subjects receiving bupropion achieved greater mean weight loss (last-observation-carried-forward analysis) over the first 8 weeks of the study (p = 0.0001): 4.9% +/- 3.4% (n = 25) for bupropion treatment compared with 1.3% +/- 2.4% (n = 25) for placebo treatment. For those who completed the 8 weeks, the comparison was 6.2% +/- 3.1% (n = 18) vs. 1.6% +/- 2.9% (n = 13), respectively(p = 0.0002), with 12 of 18 of the bupropion subjects (67%) losing over 5% of baseline body weight compared with 2 of 13 in the placebo group (15%; p = 0.0094). In the continuation phase, 14 bupropion responders who completed 24 weeks achieved weight loss of 12.9% +/- 5.6% with fat accounting for 73.5% +/- 3.7% of the weight lost and no change in bone mineral density as assessed by DXA. Bupropion was generally well-tolerated in this sample. DISCUSSION: Bupropion was more effective than placebo in achieving weight loss at 8 weeks in overweight and obese adult women in this preliminary study. Initial responders to bupropion benefited further in the continuation phase.     

Smoking cessation treatment by primary care physicians: An update and call for training

BACKGROUND: Public health and government organizations have invested considerably to increase physician adherence to smoking-cessation practice guidelines. METHODS: A random sample of 2000 U.S. primary care physicians was ascertained from the American Medical Association (AMA) in 2002. Respondents (n = 1120, 62.3%) provided self-reported data about individual and practice characteristics and smoking-cessation practices. Data were analyzed in 2005. RESULTS: Most primary care physicians (75%) advised cessation, 64% recommended nicotine patches, 67% recommended bupropion, 32% recommended nicotine gum, 10% referred to cessation experts, and 26% referred to cessation programs "often or always." Advising cessation was related to being older, having a faculty appointment, having trained staff for smoking counseling, and having confidence to counsel patients about smoking. Physicians who were internists, younger, and those with greater confidence to counsel patients about smoking recommended nicotine replacement more often. Prescribing bupropion was less common among older physicians, in the Northeast, with trained staff available for counseling, and with a greater proportion of minority or Medicaid patients. Prescribing bupropion was more common among AMA-member physicians and physicians with greater confidence to counsel patients about smoking. Providing a referral to an outside expert or program was more common among female physicians, and physicians in the Northeast or West, with larger clinical practices, and with trained staff for cessation counseling. CONCLUSIONS: Current physician self-reported practices for smoking cessation suggest opportunity for improvement. Targeted efforts to educate and support subsets of primary care physicians may improve physician adherence and smoking outcomes.     

Predictors of smoking cessation among African-Americans enrolled in a randomized controlled trial of bupropion

OBJECTIVES: Identification of individual characteristics that predict successful smoking cessation treatment has been limited to studies with mostly white participants. This study identifies factors that predict successful quitting among African-Americans participating in a smoking cessation trial. METHODS: Twenty-one baseline variables were analyzed as potential predictors from a double-blind placebo-controlled, randomized trial that used bupropion SR for smoking cessation among 600 African-American smokers. Chi-square tests, two sample t tests, and multiple logistic regression procedures were employed to identify predictors of 7-day abstinence among the 535 participants who completed the 7-week medication phase. RESULTS: Univariate predictors of cessation were receiving bupropion (P < 0.0001), not smoking menthol cigarettes (P = 0.0062), smoking after 30 min of waking (P < 0.0001), older age (P = 0.0085), smoking fewer cigarettes per day (P = 0.0038), and lower cotinine levels (P = 0.0002). Logistic regression identified three significant independent predictors. Participants who received bupropion treatment were more than twice as likely to quit smoking at the end of treatment compared to participants who received placebo (OR = 2.62; 95% CI = 1.77-3.88, P < 0.0001), while smoking within 30 min of waking (OR = 0.40; 95% CI = 0.25-0.62, P < 0.0001) and higher salivary cotinine levels at baseline (OR = 0.799; 95% CI = 0.629-0.922, P < 0.0001) reduced the likelihood of quitting. CONCLUSIONS: This is the first report identifying predictors of smoking cessation among African-Americans participating in a clinical trial. Results indicate that, aside from bupropion treatment, various indicators of addiction were the strongest predictors. While this is similar to findings among white smokers, thresholds of addiction may need to be adjusted for African-American smoking patterns. Additional studies focused on diverse populations are needed to improve treatment approaches and to identify population-specific factors that are important for treatment-matching approaches.     

Bupropion and nicotine patch as smoking cessation aids in alcoholics.

This is a double-blind placebo-controlled study of sustained-release bupropion as a smoking cessation aid in alcoholics undergoing treatment for their alcoholism. Participants (N=58) were enrolled within 1 week of entry into alcohol treatment from community and Veterans Affairs Substance Use Disorder programs. All participants received nicotine patch and were invited to attend a smoking cessation lecture and group. Cigarette smoking and alcohol outcomes were measured at 6 months. Bupropion when added to nicotine patch did not improve smoking outcomes. One third of participants on bupropion reported discontinuing the drug during weeks 1-4. Participants reported cigarette outcomes with nicotine patch that are similar to those seen in the general population. All study participants significantly reduced cigarette use. Comorbid affective disorder or antipersonality disorder did not affect outcomes. Alcohol outcomes were improved in those who discontinued cigarettes.     

Cost effectiveness analysis of smoking cessation interventions

OBJECTIVE: To identify which smoking cessation interventions provide the most efficient use of health care resources at a population level. METHODS: Effectiveness data were obtained from a review of the international literature. Costs and effects of smoking cessation interventions were estimated from the perspective of the Australian Government. Treatment costs and effects were modelled using incremental cost-effectiveness ratios. Assumptions regarding effectiveness, resource use and costs were tested by sensitivity analysis. RESULTS: From the population perspective, telephone counselling appeared to be the most cost-effective intervention. Adding proactive forms of telephone counselling increased the effectiveness of pharmacotherapies at a low incremental cost and, therefore, this could be a highly cost-effective strategy. Bupropion appeared to be more cost effective than nicotine replacement therapy (NRT). Combined bupropion and NRT did not appear to be cost effective. CONCLUSIONS: General practitioners should be encouraged to refer patients to telephone quit lines and if prescribing pharmacotherapy consider the addition of telephone counselling. IMPLICATIONS: The results support greater investment in proactive forms of telephone counselling and more formal integration of pharmacotherapies with proactive telephone counselling services as cost-effective strategies for reducing population-level smoking rates.     

Pilot Randomized Trial of Bupropion for Adolescent Methamphetamine Abuse/Dependence

PurposeTo perform a pilot clinical trial of bupropion for methamphetamine abuse/dependence among adolescents.MethodsNineteen adolescents with methamphetamine abuse (n = 2) or dependence (n = 17) were randomly assigned to bupropion SR 150 mg twice daily or placebo for 8 weeks with outpatient substance abuse counseling.ResultsBupropion was well-tolerated except for one female in the bupropion group who was hospitalized for suicidal ideation during a methamphetamine relapse. Adolescents receiving bupropion and females provided significantly fewer methamphetamine-free urine tests compared to participants receiving placebo (p = .043) and males (p = .005) respectively.ConclusionsResults do not support the feasibility of additional trials of bupropion for adolescent methamphetamine abuse/dependence. Future studies should investigate the influence of gender on adolescent methamphetamine abuse and treatment outcomes.     

Smoking cessation in a blue-collar population: results from an evidence-based pilot program

BACKGROUND: Taft Hartley Funds provide group health care coverage for 10 million union workers as well as their dependents in industries such as construction and transportation. The adult smoking rate in these populations is estimated at approximately 40%, therefore, these funds include 9 million adult smokers. The absence of evidence demonstrating the effectiveness of smoking cessation programs has kept Taft Hartley Funds from investing in smoking cessation benefits. METHODS: A prototype for Taft Hartley Funds consistent with the Federal Clinical Guidelines for Smoking Cessation was designed and implemented in a pilot demonstration in the Carpenters Health and Security Trust of Western Washington. Participants chose a 1-call or more intensive 5-call smoking cessation counseling plan provided by the Group Health Cooperative's Free and Clear program. Medications were limited to the nicotine patch, nicotine gum, and Bupropion. Assessment of outcomes was performed by Free and Clear through a telephone survey 12 months following the enrollment date. RESULTS: Nine hundred thirty-five smokers participated in the program. This pilot evaluation covers 325 participants with at least 12 months since enrollment; 75% were male, the average age was 41.4 and 63% had smoked at least one pack per day for more than 20 years. Sixty-one percent selected 5-Call Counseling; 39% 1-Call. Seventy-five percent also used smoking cessation medications: gum, 4%; patch, 32%; Bupropion 21.5%; patch plus Bupropion, 15.7%. The point-prevalence-quit rates were: overall, 27.5%; 1-Call, 25.5%; and 5-Call, 28.9%. The cost of the program was $1025.28 per smoker who quit, or $11.78 per full-time equivalent employee covered by the Fund per year. The compounded savings in reduced lifetime tobacco-related medical costs for the participants who quit are estimated to be 15 times the cost of the program, yielding an annual return on investment of 27.6%. CONCLUSIONS: These results strongly suggest that smoking cessation programs can be effective even in such hard-to-reach populations as itinerant building trades workers, provided that the program is designed to their needs and environment. Based on these findings, health plans need to consider whether they are at risk of violating their fiduciary duties if they fail to offer smoking cessation benefits.     

Cost-benefit analysis of sustained-release bupropion, nicotine patch, or both for smoking cessation

BACKGROUND: The nicotine transdermal patch (NTP) has been shown previously to be a cost-effective smoking cessation intervention. This is the first economic analysis comparing the NTP with the only non-nicotine-containing pharmacological intervention, bupropion HCl. METHODS: Decision-tree analysis, based on a previously published cost-benefit smoking-cessation model, was used to determine the optimal treatment from the standpoint of costs versus benefits, from the employer's perspective. Base-case probabilities of successful quitting in our model came from clinical trial point-prevalence data at the end of a 1-year follow-up study (N = 893) comparing placebo, bupropion, NTP, and bupropion/NTP in combination, administered along with minimal counseling. Sensitivity analyses were performed to determine the effects of variations in base-case assumptions regarding the monetary benefits that would accrue if an intervention were successful, probabilities of quitting, drug costs, cost of lost work time for a health care provider visit, and cost of the visit itself. RESULTS: The analysis showed that bupropion is more cost-beneficial than either NTP or bupropion/NTP, with a net benefit in the first post-quit year of up to $338 per employee who attempts to quit compared with $26 for NTP, $178 for the two in combination, and $258 for placebo. These results were robust to most plausible variations in the assumptions used in the model. One exception was the monetary benefit of successful intervention (assumed in the base-case to be $1,654). If this benefit were actually less than $1, 112, placebo (i.e., minimal counseling with no pharmacological intervention) would be more cost-beneficial than any of the active treatments. CONCLUSION: From an employer's perspective, bupropion 300 mg/day for 9 weeks is a more cost-beneficial smoking cessation intervention than the nicotine patch, and under most scenarios, bupropion is also more cost-beneficial than placebo.     

The Cost-Effectiveness of an Extended Course (12 + 12 Weeks) of Varenicline Compared with Other Available Smoking Cessation Strategies in the United States: An Extension and Update to the BENESCO Model

ObjectivesThis study aimed to estimate the cost-effectiveness of an extended (12 + 12 weeks) course of varenicline using the (Benefits of Smoking Cessation on Outcomes) BENESCO smoking cessation model.MethodsData on the efficacy of 12 + 12 weeks varenicline therapy in aiding smoking cessation were analyzed in conjunction with the efficacy data for 12 weeks of varenicline, bupropion, and placebo previously included in the BENESCO model, by using a mixed treatment comparison. This analysis provided updated efficacy estimates for all the interventions, and these were used to update the model to estimate the relative cost-effectiveness of all smoking cessation interventions considered, now including 12 + 12 weeks of varenicline.ResultsThe updated 1-year abstinence estimates derived from the mixed treatment comparison were, for 12 + 12 weeks of varenicline, 12 weeks of varenicline, 12 weeks of bupropion, and 12 weeks of placebo, respectively: 27.7%, 22.9%, 15.9%, and 9.3%. The average cost of the course of 12 + 12 weeks of varenicline was estimated at $603.89, based on a 12-week course followed by a further 12 weeks for successful quitters. Over all subjects' lifetimes, 12 + 12 weeks of varenicline is less costly and more effective than (dominates) all other strategies compared in the updated BENESCO model, with the exception of 12 weeks of varenicline. In this comparison, 12 + 12 weeks of varenicline is a very cost-effective alternative to the 12-week course, with an incremental cost of less than $1000 per quality-adjusted life year (QALY) gained.ConclusionsA total of 12 weeks of varenicline followed by a further 12-week course for successful quitters is a highly cost-effective alternative compared with currently available smoking cessation options.     

Alcohol history and smoking cessation in nicotine replacement therapy, bupropion sustained release and varenicline trials: a review

AIMS: We conducted a review of published reports of smoking cessation pharmacotherapy trials in order to address the following: (i) the generalizability of findings to smokers with a history of alcohol problems; (ii) the extent to which alcohol use affects smoking cessation overall and the efficacy of pharmacotherapy specifically and (iii) the effect of smoking cessation on alcohol use. METHODS: We located published reports of nicotine replacement therapy (NRT), bupropion sustained release (SR) and varenicline clinical trials using an approach based on prior Cochrane reviews. The reports were searched for alcohol-related inclusion/exclusion criteria and for findings related to alcohol. RESULTS: The present review included 212 published reports from 149 trials. Alcohol-related exclusion criteria appeared frequently (41.6% of trials)--45/125 NRT trials (36%), 15/22 bupropion SR trials (68.2%) and 3/3 varenicline trials--and most commonly involved exclusion of participants with either current or recent alcohol problems. Most studies failed to provide any baseline alcohol-related characteristics. Eleven trials reported on the relationship between alcohol history and likelihood of smoking cessation. In the majority of these studies, smokers with a past history of alcohol problems were not at a disadvantage, although contrary findings exist. Only two studies examined the potential influence of smoking cessation on alcohol use. CONCLUSIONS: Smokers with alcohol problems, particularly those with current or recent problems, are underrepresented in studies of approved pharmacotherapy for smoking cessation. Future trials should assess alcohol use at baseline and during treatment and examine reciprocal influences between alcohol consumption and smoking cessation.     

Using extended cognitive behavioral treatment and medication to treat dependent smokers

Objectives. We evaluated smoking-cessation efficacy of an extended course of sustained-release bupropion (bupropion SR) and cognitive-behavioral treatment (CBT).Methods. Participants who smoked at least 10 cigarettes per day and who smoked within 30 minutes of arising (n = 406) completed a 12-week smoking-cessation treatment including group counseling, nicotine-replacement therapy, and bupropion SR. Participants were then randomly assigned to 1 of 5 conditions: (1) no further treatment, (2) active bupropion SR for 40 weeks, (3) placebo for 40 weeks, (4) active bupropion SR and 11 sessions of CBT for 40 weeks (A-CBT), or (5) placebo and 11 sessions of CBT for 40 weeks. Participants were assessed at baseline and at weeks 12, 24, 52, 64, and 104.Results. A-CBT was not superior to the other 3 extended treatments. From weeks 12 through 104, all extended treatment conditions were superior to standard treatment. At weeks 64 and 104, the 2 CBT conditions produced significantly higher abstinence rates than did the other 3 conditions.Conclusions. Brief contact with providers can increase abstinence during treatment. CBT may increase long-term abstinence after extended treatment is terminated.Researchers and clinicians have come to expect low rates of long-term cigarette abstinence subsequent to tobacco-dependence treatment—usually 25% or less at 1 year, even with combination therapy.^1,2 These low rates may be attributable to a failure to conceputalize tobacco dependence as an addiction with a chronic, relapsing course. The implications of a chronic-disease model suggest that longer, more extended courses of tobacco-dependence treatment may result in higher long-term cigarette abstinence rates.Three studies have examined the efficacy of extended administration of sustained-release bupropion (bupropion SR). Hays et al. treated participants for 7 weeks with open-label bupropion SR and then randomly assigned only cigarette-abstinent participants (59% of the sample) to active or placebo bupropion SR for an additional 45 weeks. Cigarette abstinence was significantly higher in the active drug condition (55.1%) than in the placebo drug condition (42.3%) after 1 year of therapy, but the conditions did not differ at 2-year follow-up (41.6% for active drug; 40.0% for placebo).³ In a second study, smokers were treated with nicotine patches calibrated to individual cigarette intake. Abstinent participants (31% of the sample) were then randomly assigned to either active or placebo bupropion SR for 6 months. Abstinence rates did not differ between conditions at 6 months (25% for placebo; 28% for active drug).⁴ Cox et al.⁵ randomized abstinent smokers who had been treated with 7 weeks of bupropion SR to either continued bupropion SR for the remainder of 1 year or to placebo. Active drug produced greater cigarette abstinence at the end of treatment when compared with placebo (55.89% vs 43.58%), but there were no differences at 1-year follow-up (42.34% vs 42.95%). Thus, it appears that extended bupropion SR provides an increase in abstinence rates while being administered, but this effect is lost after medication termination.Extended administration of varenicline has also been studied. Williams et al. administered either varenicline or placebo over 1 year and found that varenicline was superior to placebo at both 12 weeks (76.5% to 72.2%) and 52 weeks (37.8% to 34.1%).⁶ Tonstad et al.⁷ randomized abstinent smokers who had been treated with 12 weeks of varenicline to either continued varenicline or to placebo for an additional 12 weeks. Continuous cigarette abstinence rates were higher for the varenicline group than for the placebo group for weeks 13 through 24 (70.5% to 49.6%) and for weeks 13 through 52 (43.6% to 36.9%). Thus, the therapeutic effects of extended varenicline may last past the period of administration.In earlier work, our group studied extended administration of nortriptyline. We assigned smokers to 1 of 4 treatment conditions in a 2 × 2 factorial design (nortriptyline vs placebo by brief treatment vs extended treatment). Participants in extended treatment continued taking drug or placebo and received monthly individual counseling sessions through week 52. At week 52, abstinence rates were 56% for extended nortriptyline and 57% for extended placebo. Both conditions produced abstinence rates that exceeded those of short-term treatment.Three studies have investigated the effects of extended cognitive-behavioral treatment (CBT). Killen et al.⁸ treated smokers for 12 weeks with open-label bupropion SR, nicotine patch, and weekly relapse-prevention training. All participants, independent of smoking status, were then offered 4 relapse-prevention sessions and continued on either active or placebo drug for an additional 14 weeks. There were no differences in abstinence rates between conditions at 1 year. In a second study⁹ participants received bupropion SR, nicotine patch, and CBT for 8 weeks and were then randomly assigned to receive either 12 weeks of CBT plus voicemail monitoring and telephone counseling or telephone-based general support. The investigators reported significant differences at 20 weeks (45% vs 29%) but not at 52 weeks (31% vs 27%).Recently, we studied 402 people who smoked at least 10 cigarettes per day and who were 50 years old or older.¹⁰ All completed a 12-week treatment that included group counseling, nicotine gum, and bupropion SR, and all were then randomly assigned to 1 of 4 follow-up conditions: (1) standard treatment (no further treatment), (2) extended nicotine-replacement therapy (NRT) with 40 weeks of nicotine gum availability, (3) extended CBT (11 cognitive behavioral sessions over a 40-week period), or (4) extended CBT plus extended NRT (11 CBT sessions plus 40 weeks of nicotine gum availability). The extended CBT condition produced high cigarette-abstinence rates that were maintained throughout the 2-year study period (week 24 = 58.3%; week 52 = 55.0%; week 64 = 54.6%; week 104 = 54.8%). The extended CBT condition was significantly more effective than extended NRT and standard treatment across that period. No other treatment condition was significantly different from standard treatment. These findings suggest that extended CBT can produce high and stable cigarette abstinence rates. Medication does not appear to play a major role in maintaining abstinence when combined with CBT.In the current study, we evaluated a CBT intervention similar to that described by Hall et al.¹⁰ We also evaluated the efficacy of long-term bupropion SR versus placebo. We proposed the following hypotheses: (1) at all assessments after baseline, the active bupropion extended CBT (A-CBT) condition would produce higher point prevalence abstinence rates than placebo with extended CBT (P-CBT), placebo alone, active bupropion alone, or standard treatment (our primary hypothesis); and (2) at all assessments after the end of extended treatment, the 2 conditions that included CBT (combined with active or placebo bupropion) would produce abstinence rates superior to those produced by the 3 conditions that did not include CBT.     

An employer-based cost-benefit analysis of a novel pharmacotherapy agent for smoking cessation

INTRODUCTION: An employer-based cost-benefit analysis for varenicline versus bupropion was conducted using clinical outcomes from a recently published trial. METHODS: A decision tree model was developed based on the net benefit of treatment to produce a nonsmoker at 1 year. Sensitivity analyses were conducted based on quit rates with placebo and varenicline and the cost of varenicline. RESULTS: Estimated 12-month employer cost savings per non-smoking employee were $540.60 for varenicline, $269.80 for bupropion SR generic, $150.80 for bupropion SR brand, and $81.80 for placebo. Varenicline was more cost beneficial than placebo, which had quit rates of 16.9% or less. The quit rate with varenicline would have to be 相似文献   

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.