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Randomized Controlled Trial
. 2010 Mar 22;170(6):543-50.
doi: 10.1001/archinternmed.2010.33.

Bupropion and cognitive behavioral therapy for weight-concerned women smokers

Affiliations
Randomized Controlled Trial

Bupropion and cognitive behavioral therapy for weight-concerned women smokers

Michele D Levine et al. Arch Intern Med. .

Abstract

Background: We previously documented that cognitive behavioral therapy for smoking-related weight concerns (CONCERNS) improves cessation rates. However, the efficacy of combining CONCERNS with cessation medication is unknown. We sought to determine if the combination of CONCERNS and bupropion therapy would enhance abstinence for weight-concerned women smokers.

Methods: In a randomized, double-blind, placebo-controlled trial, weight-concerned women (n = 349; 86% white) received smoking cessation counseling and were randomized to 1 of 2 adjunctive counseling components: CONCERNS or STANDARD (standard cessation treatment with added discussion of smoking topics but no specific weight focus), and 1 of 2 medication conditions: bupropion hydrochloride sustained release (B) or placebo (P) for 6 months. Rates and duration of biochemically verified prolonged abstinence were the primary outcomes. Point-prevalent abstinence, postcessation weight gain, and changes in nicotine withdrawal, depressive symptoms, and weight concerns were evaluated.

Results: Women in the CONCERNS + B group had higher rates of abstinence (34.0%) and longer time to relapse than did those in the STANDARD + B (21%; P = .05) or CONCERNS + P (11.5%; P = .005) groups at 6 months, although rates of prolonged abstinence in the CONCERNS + B and STANDARD + B groups did not differ significantly at 12 months. Abstinence rates and duration did not differ in the STANDARD + B group (21% and 19%) compared with the STANDARD + P group (10% and 7%) at 6 and 12 months, respectively. There were no differences among abstinent women in postcessation weight gain or weight concerns, although STANDARD + B produced greater decreases in nicotine withdrawal and depressive symptoms than did STANDARD + P.

Conclusions: Weight-concerned women smokers receiving the combination of CONCERNS + B were most likely to sustain abstinence. This effect was not related to differences in postcessation weight gain or changes in weight concerns. Trial Registration clinicaltrials.gov Identifier: NCT00006170.

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Figures

Figure 1
Figure 1
Study design overview. B indicates bupropion hydrochloride sustained release; CONCERNS, cognitive behavioral therapy for weight concerns; P, placebo; STANDARD, standard cessation counseling with added discussion of smoking topics but no specific weight focus.
Figure 2
Figure 2
Participant disposition. See Figure 1 legend for abbreviations.
Figure 3
Figure 3
Time to relapse by treatment group. Note: overall log rank (LR) χ32=19.06 (P < .001). Between-group comparisons at 6 months: (1) CONCERNS + B vs STANDARD + B, LR χ2 = 3.81 (P = .051); (2) CONCERNS + B vs CONCERNS + P, LR χ2 = 15.74 (P <.001); and (3) STANDARD + B vs STANDARD + P, LR χ2 = 2.51 (P = .11). Between-group comparisons at 12 months: (1) overall LR χ32=16.79 (P < .001); (2) CONCERNS + B vs STANDARD + B: LR χ2 = 2.20 (P = .14); (3) CONCERNS + B vs CONCERNS + P: LR χ2 = 11.5 (P = .001); and (4) STANDARD + B vs STANDARD + P: LR χ2 = 3.4 (P = .07). See Figure 1 legend for abbreviations.

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