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ABSTRACT
BACKGROUND: Despite public health campaigns and recommendations from national organizations for clinicians to encourage smoking cessation, only 2.5% of all smokers succeed in abstaining for 1 year. Currently, bupropion (Zyban) is an antidepressant approved by the FDA as an aid in smoking cessation. This study evaluated the safety and efficacy of another antidepressant, nortriptyline (Pamelor), in smokers enrolled in a smoking support group.
POPULATION STUDIED: Patients were participating in a hospital-based smoking support group in Brazil. They were in good general health, aged 18 to 65 years, and smoked more than 15 cigarettes per day. Degree of nicotine dependence was determined by the Fagerstrom questionnaire. Patients were excluded if they were depressed as determined by the Beck Depression Inventory or had a history of other psychiatric syndromes, cardiovascular disease, glaucoma, urinary retention, thyroid disease, or epilepsy, or were pregnant or breast-feeding. Patients could not be receiving nicotine replacement therapy or have taken antidepressants, benzodiazepines, or antipsychotic agents during the past month. Of 144 patients who completed the study, most were women.
STUDY DESIGN AND VALIDITY: Patients were randomly assigned to receive either placebo or nortriptyline, increased at weekly intervals from 25 to 75 mg daily. Patients and clinicians were blinded to assigned treatment. During the 6-week treatment, all patients participated in weekly group therapy supervised by the same psychiatrist. Group therapy was based on cognitive-behavioral therapy. Follow-up abstinence rates were evaluated 6 months after the treatment period.
OUTCOMES MEASURED: Success was defined as cessation of smoking 1 week after the end of the treatment period. The rate of abstinence was also determined 6 months after the end of the study.
RESULTS: Patients receiving nortriptyline were less likely to report smoking in the week after the treatment period (55.9% vs 23.7% in the placebo group, P < .001, numbers needed to treat [NNT]=3). After 6 months of follow-up, 20.6% of patients receiving nortriptyline and 5.3% of patients receiving placebo reported to be free from nicotine use (P < .012, NNT=7). Patients most likely to respond had low nicotine dependence (Fagerstrom score less than 7 out of a possible 10) and were younger than 50 years.
Nortriptyline (Pamelor), in combination with weekly behavioral therapy, is effective in helping highly motivated smokers to quit. The medication may be an alternative for patients who cannot tolerate or do not benefit from bupropion. Given the high motivation of the group and the extensive behavioral therapy they also received, results are not likely to be as good in typical practice.
ABSTRACT
BACKGROUND: Despite public health campaigns and recommendations from national organizations for clinicians to encourage smoking cessation, only 2.5% of all smokers succeed in abstaining for 1 year. Currently, bupropion (Zyban) is an antidepressant approved by the FDA as an aid in smoking cessation. This study evaluated the safety and efficacy of another antidepressant, nortriptyline (Pamelor), in smokers enrolled in a smoking support group.
POPULATION STUDIED: Patients were participating in a hospital-based smoking support group in Brazil. They were in good general health, aged 18 to 65 years, and smoked more than 15 cigarettes per day. Degree of nicotine dependence was determined by the Fagerstrom questionnaire. Patients were excluded if they were depressed as determined by the Beck Depression Inventory or had a history of other psychiatric syndromes, cardiovascular disease, glaucoma, urinary retention, thyroid disease, or epilepsy, or were pregnant or breast-feeding. Patients could not be receiving nicotine replacement therapy or have taken antidepressants, benzodiazepines, or antipsychotic agents during the past month. Of 144 patients who completed the study, most were women.
STUDY DESIGN AND VALIDITY: Patients were randomly assigned to receive either placebo or nortriptyline, increased at weekly intervals from 25 to 75 mg daily. Patients and clinicians were blinded to assigned treatment. During the 6-week treatment, all patients participated in weekly group therapy supervised by the same psychiatrist. Group therapy was based on cognitive-behavioral therapy. Follow-up abstinence rates were evaluated 6 months after the treatment period.
OUTCOMES MEASURED: Success was defined as cessation of smoking 1 week after the end of the treatment period. The rate of abstinence was also determined 6 months after the end of the study.
RESULTS: Patients receiving nortriptyline were less likely to report smoking in the week after the treatment period (55.9% vs 23.7% in the placebo group, P < .001, numbers needed to treat [NNT]=3). After 6 months of follow-up, 20.6% of patients receiving nortriptyline and 5.3% of patients receiving placebo reported to be free from nicotine use (P < .012, NNT=7). Patients most likely to respond had low nicotine dependence (Fagerstrom score less than 7 out of a possible 10) and were younger than 50 years.
Nortriptyline (Pamelor), in combination with weekly behavioral therapy, is effective in helping highly motivated smokers to quit. The medication may be an alternative for patients who cannot tolerate or do not benefit from bupropion. Given the high motivation of the group and the extensive behavioral therapy they also received, results are not likely to be as good in typical practice.
ABSTRACT
BACKGROUND: Despite public health campaigns and recommendations from national organizations for clinicians to encourage smoking cessation, only 2.5% of all smokers succeed in abstaining for 1 year. Currently, bupropion (Zyban) is an antidepressant approved by the FDA as an aid in smoking cessation. This study evaluated the safety and efficacy of another antidepressant, nortriptyline (Pamelor), in smokers enrolled in a smoking support group.
POPULATION STUDIED: Patients were participating in a hospital-based smoking support group in Brazil. They were in good general health, aged 18 to 65 years, and smoked more than 15 cigarettes per day. Degree of nicotine dependence was determined by the Fagerstrom questionnaire. Patients were excluded if they were depressed as determined by the Beck Depression Inventory or had a history of other psychiatric syndromes, cardiovascular disease, glaucoma, urinary retention, thyroid disease, or epilepsy, or were pregnant or breast-feeding. Patients could not be receiving nicotine replacement therapy or have taken antidepressants, benzodiazepines, or antipsychotic agents during the past month. Of 144 patients who completed the study, most were women.
STUDY DESIGN AND VALIDITY: Patients were randomly assigned to receive either placebo or nortriptyline, increased at weekly intervals from 25 to 75 mg daily. Patients and clinicians were blinded to assigned treatment. During the 6-week treatment, all patients participated in weekly group therapy supervised by the same psychiatrist. Group therapy was based on cognitive-behavioral therapy. Follow-up abstinence rates were evaluated 6 months after the treatment period.
OUTCOMES MEASURED: Success was defined as cessation of smoking 1 week after the end of the treatment period. The rate of abstinence was also determined 6 months after the end of the study.
RESULTS: Patients receiving nortriptyline were less likely to report smoking in the week after the treatment period (55.9% vs 23.7% in the placebo group, P < .001, numbers needed to treat [NNT]=3). After 6 months of follow-up, 20.6% of patients receiving nortriptyline and 5.3% of patients receiving placebo reported to be free from nicotine use (P < .012, NNT=7). Patients most likely to respond had low nicotine dependence (Fagerstrom score less than 7 out of a possible 10) and were younger than 50 years.
Nortriptyline (Pamelor), in combination with weekly behavioral therapy, is effective in helping highly motivated smokers to quit. The medication may be an alternative for patients who cannot tolerate or do not benefit from bupropion. Given the high motivation of the group and the extensive behavioral therapy they also received, results are not likely to be as good in typical practice.