A Controlled Trial of Sustained-Release Bupropion, a Nicotine Patch, or Both for Smoking Cessation
Douglas E. Jorenby, Ph.D., Scott J. Leischow, Ph.D., Mitchell A. Nides, Ph.D., Stephen I. Rennard, M.D., J. Andrew Johnston, Pharm.D., Arlene R. Hughes, Ph.D., Stevens S. Smith, Ph.D., Myra L. Muramoto, M.D., David M. Daughton, M.S., Kimberli Doan, B.S., Michael C. Fiore, M.D., M.P.H., and Timothy B. Baker, Ph.D.
Background and Methods Use of nicotine-replacement therapiesand the antidepressant bupropion helps people stop smoking.We conducted a double-blind, placebo-controlled comparison ofsustained-release bupropion (244 subjects), a nicotine patch(244 subjects), bupropion and a nicotine patch (245 subjects),and placebo (160 subjects) for smoking cessation. Smokers withclinical depression were excluded. Treatment consisted of nineweeks of bupropion (150 mg a day for the first three days, andthen 150 mg twice daily) or placebo, as well as eight weeksof nicotine-patch therapy (21 mg per day during weeks 2 through7, 14 mg per day during week 8, and 7 mg per day during week9) or placebo. The target day for quitting smoking was usuallyday 8.
Results The abstinence rates at 12 months were 15.6 percentin the placebo group, as compared with 16.4 percent in the nicotine-patchgroup, 30.3 percent in the bupropion group (P<0.001), and35.5 percent in the group given bupropion and the nicotine patch(P<0.001). By week 7, subjects in the placebo group had gainedan average of 2.1 kg, as compared with a gain of 1.6 kg in thenicotine-patch group, a gain of 1.7 kg in the bupropion group,and a gain of 1.1 kg in the combined-treatment group (P<0.05).Weight gain at seven weeks was significantly less in the combined-treatmentgroup than in the bupropion group and the placebo group (P<0.05for both comparisons). A total of 311 subjects (34.8 percent)discontinued one or both medications. Seventy-nine subjectsstopped treatment because of adverse events: 6 in the placebogroup (3.8 percent), 16 in the nicotine-patch group (6.6 percent),29 in the bupropion group (11.9 percent), and 28 in the combined-treatmentgroup (11.4 percent). The most common adverse events were insomniaand headache.
Conclusions Treatment with sustained-release bupropion aloneor in combination with a nicotine patch resulted in significantlyhigher long-term rates of smoking cessation than use of eitherthe nicotine patch alone or placebo. Abstinence rates were higherwith combination therapy than with bupropion alone, but thedifference was not statistically significant.
Each year, approximately 20 million of the 50 million smokersin the United States try to quit smoking, but only about 6 percentof those who try succeed in quitting in the long term.1 Nicotine-replacementtherapies, such as the nicotine patch and nicotine gum, boostthe rates of smoking cessation by a factor of 1.4 to 2.6 incomparison with placebo treatments,2 but 70 to 80 percent ofsmokers who use these therapies still start to smoke again.
Affect or mood appears to exert potent effects on the motivationto use nicotine.3,4,5 For instance, among smokers, symptomsof nicotine dependence are correlated with the magnitude ofaffective symptoms of depression.6 In population-based studies,smokers are more likely than nonsmokers to have symptoms ofaffective disorders.6 Persons with a negative affect are morelikely to start smoking and less likely to be able to quit7,8,9— effects that may be related to changes in dopaminergicactivity in the brain.10 Antidepressants or anxiolytics maytherefore be efficacious cessation aids.3,11 Hurt and colleagues12demonstrated that bupropion is an effective smoking-cessationaid: at 12 months, the abstinence rates were 23 percent amongsubjects assigned to receive 300 mg of bupropion per day for7 weeks and 12 percent among subjects assigned to receive placebo.We compared bupropion, placebo, a nicotine patch,2 and a combinationof bupropion and the nicotine patch with regard to efficacy.13We also examined whether treatment with bupropion amelioratesnicotine-withdrawal symptoms such as negative mood.
Methods
Subjects, Screening, and Randomization
Subjects were recruited at four study sites by advertisementsin the media. The first subject was enrolled in August 1995,and follow-up was completed in March 1997. Of a total of 1182persons who were screened, 893 met the screening criteria andwere enrolled: 218 in Arizona, 227 in California, 220 in Nebraska,and 228 in Wisconsin. The subjects were randomly assigned toone of four treatments with use of an unequal-cell design: 160subjects were assigned to receive placebo, 244 to receive thenicotine patch, 244 to receive bupropion, and 245 to receivebupropion and the nicotine patch. Randomization was not balancedwithin sites.
The subjects were screened by means of a telephone interviewand a pretreatment session that included a physical examination,electrocardiography, and chest roentgenography. The study protocolwas approved by the institutional review board at each site.All participants provided written informed consent.
To be eligible for the study, subjects had to be at least 18years of age, to smoke at least 15 cigarettes per day, to weighat least 45.4 kg (100 lb), to be motivated to quit smoking,and to speak English. Only one smoker per household was allowedto enroll in the study. Subjects were excluded for the followingreasons: serious or unstable cardiac, renal, hypertensive, pulmonary,endocrine, or neurologic disorders, as assessed by the study-sitephysician; ulcers; seizure or dermatologic disorders; a currentdiagnosis of major depressive episode or a history of panicdisorder, psychosis, bipolar disorder, or eating disorders;use of a nicotine-replacement therapy within six months beforestudy enrollment; pregnancy or lactation; abuse of alcohol ora non–nicotine-containing drug within the preceding year;use of a psychoactive drug within the week before enrollment;use of an investigational drug within the month before enrollment;prior use of bupropion; current use of other smoking-cessationtreatments; and regular use of any noncigarette tobacco product.
Treatment Period
The treatment period was nine weeks. Target quitting dates wereset for the second week, usually day 8. Participants were assessedweekly and attended a brief (15 minutes or less) individualcounseling session for smoking cessation each week. Counselingtopics included motivation, identification of smoking triggers,coping responses, weight management, and use of the medications.The counselors used a standardized treatment developed by Hurtand colleagues.12 The subjects also received a supportive telephonecall from a counselor approximately three days after the targetquitting date.
Follow-Up Period
Follow-up assessments and relapse-prevention counseling occurredduring clinic visits 10, 12, 26, and 52 weeks after the startof the study. In addition to clinic visits, subjects receivedeight telephone calls from a counselor during this period, oneper month in months 3, 4, and 5 and 7 to 11. All follow-up counselingwas less than 10 minutes in duration per call.
Medications
Subjects in the two bupropion groups received 150-mg tabletsof sustained-release bupropion (Zyban, Glaxo Wellcome), andall other subjects received identical-appearing tablets. Inthe bupropion groups, subjects received 150 mg of bupropionin the morning and a placebo tablet in the evening on days 1,2, and 3 of treatment; and one bupropion tablet in the morningand one in the evening on days 4 to 63. All other subjects tookplacebo tablets twice daily from days 1 to 63. Subjects in thenicotine-patch groups used one patch (Habitrol, Novartis ConsumerHealth) per day for eight weeks beginning on the quitting day(day 8). All other subjects applied a placebo patch each dayfor eight weeks. The patches used from weeks 2 to 7 each contained21 mg of nicotine; those used during week 8 each contained 14mg, and those used during week 9 each contained 7 mg.
Assessments
At base line, serum cotinine, vital signs, and exhaled carbonmonoxide were determined; data on smoking history were obtained;and three questionnaires were administered. The portion of theStructured Clinical Interview for the Diagnostic and StatisticalManual of Mental Disorders, fourth edition (DSM-IV), concerningmood disorders was used to assess whether subjects had mooddisorders. The Beck Depression Inventory14 assesses the severityof depression. Scores of 0 to 9 are considered to be normal,scores of 10 to 18 indicate mild-to-moderate depression, scoresof 19 to 29 indicate moderate-to-severe depression, and scoresof 30 to 63 indicate severe depression. The FagerströmTolerance Questionnaire15 measures nicotine dependence. Scorescan range from 0 to 11, with higher scores indicating more severedependence.
During the treatment period, vital signs were assessed and thecarbon monoxide content of expired air was measured. All subjectswere asked to keep a daily diary for the first 12 weeks of thestudy that included information on smoking status, craving,and withdrawal symptoms. During the follow-up period, the BeckDepression Inventory was given, vital signs and the carbon monoxidecontent of expired air were measured, and self-reported smokingstatus was assessed.
Measures of Outcome
All 893 subjects were included in analyses of the primary outcome.The primary outcome variable was the point-prevalence rate ofabstinence at 6 and 12 months of follow-up. Subjects were consideredto be abstinent if they reported not smoking since the precedingclinic visit and had an expired carbon monoxide concentrationof 10 ppm or less. Subjects were considered to be continuouslyabstinent if they had not smoked after the quitting day, asconfirmed by a carbon monoxide concentration of 10 ppm or lessat all clinic visits during the 12-month study. Secondary outcomemeasures included withdrawal symptoms, body weight, and BeckDepression Inventory scores.
Statistical Analysis
Chi-square and analysis of variance were used to test for base-linedifferences in demographic and smoking-history variables.16All statistical tests were two-sided and had an alpha levelof 0.05. Sample sizes were based on the results of a previousstudy of bupropion in which the abstinence rates at four weekswere 40 percent in the bupropion group and 24 percent in theplacebo group.12 We estimated that 130 subjects were neededin the placebo group and 230 subjects were needed in the treatmentgroups for the study to have a power of 0.80 to detect sucha difference at an alpha level of 0.05. All subjects who discontinuedtreatment early or who were lost to follow-up were classifiedas smokers.
Logistic-regression analysis17 was used to determine pairwisedifferences among groups in the abstinence rates. The Kaplan–Meiermethod was used to analyze differences in rates of continuousabstinence; homogeneity among treatments and pairwise differenceswere tested with the log-rank test.16
Withdrawal symptoms were assessed daily with a composite scorecalculated as the mean of eight items in the daily diary: cravingfor cigarettes; restlessness; increased appetite; depressedmood; anxiety; difficulty concentrating; irritability, frustration,or anger; and difficulty sleeping (DSM-IV symptoms plus craving).18,19The severity of each symptom was rated on a five-point scale,as absent (0), slight (1), mild (2), moderate (3), or severe(4). Repeated-measures analysis of variance was used to analyzethe change in scores from base line (before smoking cessation)to after smoking cessation. Group coding was used that permittedtests of the independent and interactive effects of the twopharmacotherapies. In one analysis, the changes in scores duringthe first six days after the quitting date were analyzed; ina second analysis, the changes in scores during each week ofthe eight-week period after the quitting date were analyzed.To control experiment-wise error, Tukey's studentized rangetest16 was used for pairwise group comparisons of changes inscores that were found to be significantly different; this samestrategy was used to analyze body weight and Beck DepressionInventory scores. Adverse events that began or increased duringthe treatment phase were coded with COSTART (Coding Symbolsfor Thesaurus of Adverse Reaction Terms),20 and differencesbetween groups were tested by Fisher's exact test.
Results
Base-Line Characteristics and Rates of Discontinuation
The base-line characteristics of the study subjects are shownin Table 1. There were no significant differences among thegroups. There were no significant interactions between siteand treatment for the point-prevalence rates of abstinence at6 and 12 months.
Table 1. Base-Line Characteristics of the Subjects.
A total of 311 subjects (34.8 percent) discontinued treatment:177 left the study and provided no additional information, whereas134 stopped taking the medication but participated in follow-upassessments. Subjects in the placebo group had the highest rateof discontinued treatment (48.8 percent); the rates were 31.1percent in the bupropion group, 35.7 percent in the nicotine-patchgroup, and 28.6 percent in the combined-treatment group.
Abstinence Rates
Figure 1A shows the point-prevalence rates of abstinence fromsmoking, as confirmed by biochemical tests. The point-prevalencerates of abstinence at four weeks were significantly higherin all three treatment groups (48.0, 60.2, and 66.5 percentfor the nicotine-patch group, bupropion group, and combined-treatmentgroup, respectively) than in the placebo group (33.8 percent;P=0.005, P<0.001, and P<0.001, respectively). Thereafter,only the bupropion group and the combined-treatment group hadsignificantly higher point-prevalence rates of abstinence thanthe placebo group (Figure 1A and Table 2).
Figure 1. Point-Prevalence Rates of Abstinence (Panel A) and Rates of Continuous Abstinence (Panel B) during Treatment (Weeks 1–9) and Follow-up (Weeks 10–52).
The point-prevalence rates of abstinence at four weeks were significantly higher in all three treatment groups than in the placebo group (P=0.005 for the comparison with the nicotine-patch group, P<0.001 for the comparison with the bupropion group, and P<0.001 for the comparison with the group given the nicotine patch and bupropion). For continuous abstinence, all three active treatments were superior to placebo (P<0.001), bupropion alone and in combination with the nicotine patch was superior to the nicotine patch alone (P<0.001), and there was no significant difference between bupropion alone and bupropion in combination with the nicotine patch (P=0.61). I bars indicate standard errors.
Analyses of the rates of continuous abstinence (Figure 1B) duringthe 12-month period showed that the rates were higher in allthree active-treatment groups than in the placebo group (P<0.001),the rates were higher in the two bupropion groups than in thenicotine-patch group (P<0.001), and the rates in the twobupropion groups were not significantly different from one another(P=0.61). The mean (±SE) rates of continuous abstinenceat 12 months were 5.6±0.02 percent in the placebo group,9.8±0.02 percent in the nicotine-patch group, 18.4±0.03percent in the bupropion group, and 22.5±0.03 percentin the combined-treatment group.
Symptoms of Withdrawal and Depression
Figure 2A and Figure 2Bshows the mean changes in withdrawalsymptoms from base line for all subjects (regardless of whetheror not they were smoking). The changes were analyzed daily duringthe first six days after the quitting date and then weekly untilthe end of treatment. All four groups had significant increasesin withdrawal symptoms during the first week of treatment (P<0.001).However, the changes were smaller in the three active-treatmentgroups than in the placebo group during the first six days afterthe quitting date and during the following weeks.
Figure 2. Mean Change from Base Line in Composite Withdrawal Scores.
The changes in scores were analyzed daily during the first six days after the quitting date (Panel A) and then weekly until the end of treatment (Panel B). The mean changes in scores could range from –4 to +4. Tukey's studentized range test was used to assess differences among the groups. Asterisks indicate P<0.05 for the comparison with all three active-treatment groups. Daggers indicate P<0.05 for the comparison with the nicotine-patch group and the combined-treatment group. Double dagger indicates P<0.05 for the comparison with the combined-treatment group. Section mark indicates P<0.05 for the comparison with the bupropion group and the combined-treatment group.
The Beck Depression Inventory scores were within the range ofnormal at base line (Table 1). Treatment had no effect on thescores. Analyses did not show any interaction between repeatedmeasures and treatment during treatment and follow-up.
Weight Change
At the beginning of treatment, there were no significant differencesin mean body weight among the four groups (Table 1). By week7 (after which the nicotine-patch dose was decreased from 21to 14 mg per day), subjects in the placebo group had gainedan average of 2.1 kg, as compared with a gain of 1.6 kg in thenicotine-patch group, 1.7 kg in the bupropion group, and 1.1kg in the combined-treatment group. Pairwise group comparisonsby Tukey's studentized range test at week 7 indicated that thesubjects in the combined-therapy group had gained significantlyless weight than those in the placebo group (P<0.05) or thebupropion group (P<0.05). There were no significant differencesbetween groups in mean weight changes after week 7.
Safety
Table 3 shows the adverse events reported by 10 percent or moreof the subjects in any of the groups. Insomnia was the mostcommonly reported adverse event, occurring among 47.5 percentof the subjects in the combined-treatment group, 42.4 percentof those in the bupropion group, 30.0 percent of those in thenicotine-patch group, and 19.5 percent of those in the placebogroup. Reactions at the application site and dream abnormalitieswere most common among the subjects who used the nicotine patch.
A total of 79 subjects (8.8 percent) discontinued medicationbecause of adverse events: 6 in the placebo group (3.8 percent),16 in the nicotine-patch group (6.6 percent), 29 in the bupropiongroup (11.9 percent), and 28 in the combined-treatment group(11.4 percent). The rates of discontinuation of treatment werehigher among those receiving bupropion (P=0.004) and those receivingcombined treatment (P=0.007) than among those receiving placebo.There was a nonsignificant trend (P=0.24) toward a greater incidenceof new or worsening hypertension during the treatment periodamong those receiving combined therapy than among those receivingplacebo (6.1 percent vs. 3.1 percent). No seizures were reportedin any group.
Five serious adverse events were reported during treatment.Three were dermatologic or allergic reactions in subjects whowere taking bupropion, one of whom was also using a nicotinepatch. All three had rash and pruritus, and one also had shortnessof breath and chest tightness. The symptoms began 14 to 20 daysafter the start of therapy. Treatment was stopped, and the threesubjects received glucocorticoids and antihistamines. All hadfull resolution of symptoms. These reactions were attributedto bupropion.
The two other serious adverse events consisted of viral spinalmeningitis in a 38-year-old woman 60 days after the initiationof nicotine-patch therapy and chest pain in a 46-year-old manwho was hospitalized 4 days after beginning bupropion therapy.He was discharged one day later with a diagnosis of gastricreflux, and the symptoms resolved after treatment with omeprazole.The meningitis and gastric reflux were not attributed to thestudy medications.
Discussion
We found that treatment with bupropion alone or in combinationwith a nicotine patch resulted in higher long-term abstinencerates than did the use of placebo or a nicotine patch alone.Treatment with both bupropion and the nicotine patch was notsignificantly better than treatment with bupropion alone eitherat the end of the treatment period or during follow-up. As comparedwith the use of placebo, treatment with the nicotine patch,the nicotine patch and bupropion, and bupropion alone all resultedin less severe withdrawal symptoms and less weight gain aftersmoking cessation. Previous research has also shown that bupropionand nicotine-replacement therapies can reduce weight gain aftersmoking cessation.12,21,22,23 Although weight gain was lowestin the combined-treatment group, there were no significant differencesin weight gain among the groups after week 7 of treatment.
The subjects in our study were all volunteers and thus may notbe representative of the majority of smokers.24 Moreover, allsubjects underwent weekly biochemical tests to determine whetherthey were still smoking. Both these factors could have enhancedcessation rates. The fact that 19.8 percent of the subjectsdropped out of the study must also be considered. Those whodropped out of the study were assumed to have resumed smoking,but data on factors such as weight, depression, and severityof withdrawal had to be treated as missing for these subjects,so the potential contribution of these factors remains unknown.
Analyses of data on continuous abstinence showed that relativeto placebo, use of the nicotine patch was associated with higherabstinence rates during the 12-month follow-up period. The oddsratio for the comparison between the nicotine patch and placeboat one year was 1.1, similar to values reported in previouswork.2 However, analyses of point-prevalence data showed nosignificant differences between these two groups during follow-up.It is unclear why the nicotine patch produced weak effects accordingto the point-prevalence analysis. One study suggested that theuse of two placebos in a control group may produce higher smoking-cessationrates than the use of a single placebo.25 This might accountfor the smaller difference in the long-term rates of smokingcessation between the placebo group and the nicotine-patch groupin our study. The weak effects, however, seem unrelated to prioruse of the nicotine patch. The rate of previous use of a nicotinepatch was similar among the four groups. In the nicotine-patchgroup, there was no significant difference in the rates of continuousabstinence at 12 months between subjects who had previouslyused patches and those who had not (8.6 percent vs. 10.6 percent,P=0.61).
Supported by a grant from Glaxo Wellcome.
Dr. Jorenby has organized medical-education presentations sponsoredby Glaxo Wellcome and SmithKline Beecham. Dr. Leischow has servedas a consultant for McNeil Consumer Products, Pharmacia &Upjohn, and Glaxo Wellcome and has organized medical-educationpresentations sponsored by Glaxo Wellcome. Dr. Nides has servedas a consultant for Glaxo Wellcome, Novartis, and SmithKlineBeecham and has organized medical-education presentations sponsoredby Glaxo Wellcome. Dr. Rennard has served as a consultant forGlaxo Wellcome, Novartis, and SmithKline Beecham and has organizedmedical-education presentations sponsored by Glaxo Wellcome.Dr. Muramoto has organized medical-education presentations sponsoredby Glaxo Wellcome. Mr. Daughton has served as a consultant forSmithKline Beecham and Hoechst Marion Roussel and has organizedmedical-education presentations sponsored by Glaxo Wellcomeand Hoechst Marion Roussel. Dr. Fiore has served as a consultantfor Novartis, Glaxo Wellcome, SmithKline Beecham, and McNeilConsumer Products and has organized medical-education presentationssponsored by Novartis, Elan Pharma, Lederle Laboratories, GlaxoWellcome, McNeil Consumer Products, and SmithKline Beecham.Dr. Baker has served as a consultant for SmithKline Beechamand has organized medical-education presentations sponsoredby Elan Pharma and Glaxo Wellcome.
Source Information
From the Center for Tobacco Research and Intervention, University of Wisconsin Medical School, Madison (D.E.J., S.S.S., M.C.F., T.B.B.); the Arizona Program for Nicotine and Tobacco Research, University of Arizona, Tucson (S.J.L., M.L.M.); Los Angeles Clinical Trials, Los Angeles (M.A.N., K.D.); the Pulmonary and Critical Care Medicine Section, University of Nebraska Medical Center, Omaha (S.I.R., D.M.D.); and Glaxo Wellcome, Research Triangle Park, N.C. (J.A.J., A.R.H.).
Address reprint requests to Dr. Jorenby at 1300 University Ave., Rm. 7278 MSC, Madison, WI 53706.
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Smoking Cessation
Hughes J. R., Jorenby D. E., Fiore M. C., Baker T. B.
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N Engl J Med 1999;
341:610-611, Aug 19, 1999.
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A correction has been published: N Engl J Med 1999;341(8):610.
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