The study is among the first on nortriptyline, according to the study's lead author. "There are very few studies about nortriptyline in the literatures," said Florin Martinez, National Institute of Lung Disease, Bucharest, Romania.

The double-blind study assigned patients to three groups. The 52 patients in the nortriptyline group received a dosage of 25 mg per day for the first 5 days followed by 75 mg per day. The 53 subjects in the bupropion group received 150 mg per day of the sustained-release formulation for the first 5 days followed by 150 mg twice daily. The placebo group had 51 patients.

After a 4-week run-in period, treatment continued for 9 weeks with the target for smoking cessation at day 10.

At 3 months, there was no significant difference in abstinence rates among the three groups. After 6 months, the abstinence rates were 21.6% in the placebo group, 30.8% in the nortriptyline group (P =.40), and 41.5% in the bupropion group (P =.05).

Bupropion was shown to significantly improve the smoking cessation rate compared to placebo, which confirms the results of other studies. However, nortriptyline did not improve the rate enough to reach significance compared to placebo.

Although it would appear that bupropion is superior to nortriptyline in helping smokers quit smoking, the difference between the nortriptyline and bupropion groups was not statistically significant (P =.35).

"We believe nortriptyline is not as powerful [as bupropion], but that is not proven," said Jose Miguel Chatkin, MD, Pontificia Universidade Catolica, Porto Alegre, Brazil. "Right now it is only a feeling."

The most common adverse events were dry mouth and drowsiness in the nortriptyline group and dry mouth and insomnia in the bupropion group, but there was not a significant difference in adverse effects between the groups, said Dr. Chatkin.

Dr. Chatkin said the research group plans to continue studying the comparison between bupropion and nortriptyline.

"We need to increase the number of patients," he said.


[Presentation title: "A Controlled Trial of Nortriptyline or Sustained-Release Bupropion for Smoking Cessation." Abstract 2901]

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