Sustained-release bupropion for pharmacologic relapse prevention after smoking cessation. a randomized, controlled trial

Ann Intern Med. 2001 Sep 18;135(6):423-33. doi: 10.7326/0003-4819-135-6-200109180-00011.


Background: Smoking relapse is common after successful pharmacologic treatment for smoking cessation. No previous studies have examined long-term drug therapy used expressly for prevention of smoking relapse.

Objective: To evaluate the efficacy of bupropion to prevent smoking relapse.

Design: Randomized, placebo-controlled trial.

Participants: 784 healthy community volunteers who were motivated to quit smoking and who smoked at least 15 cigarettes per day.

Intervention: The participants received open-label, sustained-release bupropion, 300 mg/d, for 7 weeks. Participants who were abstinent throughout week 7 of open-label treatment were randomly assigned to receive bupropion, 300 mg/d, or placebo for 45 weeks and were subsequently followed for an additional year after the conclusion of the medication phase. Participants were briefly counseled at all follow-up visits. At the end of open-label bupropion treatment, 461 of 784 participants (58.8%) were abstinent from smoking.

Measurement: Self-reported abstinence was confirmed by an expired air carbon monoxide concentration of 10 parts per million or less.

Results: The point prevalence of smoking abstinence was significantly higher in the bupropion group than in the placebo group at the end (week 52) of drug therapy (55.1% vs. 42.3%, respectively; P = 0.008) and at week 78 (47.7% vs. 37.7%; P = 0.034) but did not differ at the final (week 104) follow-up visit (41.6% vs. 40.0%). The median time to relapse was significantly greater for bupropion recipients than for placebo recipients (156 days vs. 65 days; P = 0.021). The continuous abstinence rate was higher in the bupropion group than in the placebo group at study week 24 (17 weeks after randomization) (52.3% vs. 42.3%; P = 0.037) but did not differ between groups after week 24. Weight gain was significantly less in the bupropion group than in the placebo group at study weeks 52 (3.8 kg vs. 5.6 kg; P = 0.002) and 104 (4.1 kg vs. 5.4 kg; P = 0.016).

Conclusions: In persons who stopped smoking with 7 weeks of bupropion treatment, sustained-release bupropion for 12 months delayed smoking relapse and resulted in less weight gain.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Bupropion / administration & dosage*
  • Bupropion / adverse effects
  • Delayed-Action Preparations
  • Double-Blind Method
  • Female
  • Humans
  • Male
  • Middle Aged
  • Patient Compliance
  • Recurrence
  • Smoking Cessation / methods*
  • Smoking Prevention*
  • Weight Gain


  • Delayed-Action Preparations
  • Bupropion