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Randomized Controlled Trial
. 2007 Sep 6;90(1):56-63.
doi: 10.1016/j.drugalcdep.2007.02.008. Epub 2007 Mar 13.

Bupropion SR for the treatment of smokeless tobacco use

Lowell C Dale  1 , Jon O Ebbert, Elbert D Glover, Ivana T Croghan, Darrell R Schroeder, Herbert H Severson, Richard D Hurt
Affiliations
Randomized Controlled Trial

Bupropion SR for the treatment of smokeless tobacco use

Lowell C Dale et al. Drug Alcohol Depend. .

Abstract

Background: No pharmacotherapies have been shown to increase long-term (> or = 6 months) tobacco abstinence rates among smokeless tobacco (ST) users. Bupropion SR has demonstrated potential efficacy for ST users in pilot studies. We conducted a multicenter, randomized, double-blind, placebo-controlled, clinical trial to assess the efficacy and safety of bupropion SR for tobacco abstinence among ST users.

Methods: Adult ST users were randomized to bupropion SR titrated to 150 mg twice daily (N=113) or placebo (N=112) for 12 weeks plus behavioral intervention. The primary endpoint was the 7-day point-prevalence tobacco abstinence rate at week 12. Secondary outcomes included prolonged and continuous tobacco abstinence rates, craving and nicotine withdrawal, and weight gain.

Results: The 7-day point-prevalence tobacco abstinence rates did not differ between bupropion SR and placebo at the end treatment (53.1% versus 46.4%; odds ratio (OR) 1.3; p=0.301). The 7-day point-prevalence abstinence did not differ at weeks 24 and 52. The prolonged and continuous tobacco abstinence rates did not differ at weeks 12, 24, and 52. A time-by-treatment interaction was observed in craving over time with greater decreases in the bupropion SR group. At 12 weeks, the mean (+/-S.D.) weight change from baseline among abstinent subjects was an increase of 1.7 (+/-2.9)kg for the bupropion SR group compared to 3.2 (+/-2.7)kg for placebo (p=0.005).

Conclusions: Bupropion SR did not significantly increase tobacco abstinence rates among ST users, but it significantly decreased craving and weight gain over the treatment period.

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Figures

Fig. 1
Fig. 1
Study flow diagram.
Fig. 2
Fig. 2
Point-prevalence tobacco abstinence rates according to treatment group. At each visit, subjects were classified as abstinent if they self-reported abstinence from all tobacco for the previous 7 days confirmed by urine cotinine < 50 ng/mL. An asterisk (*) indicates a significant (p ≤ 0.05) difference between treatment groups.
Fig. 3
Fig. 3
Mean score for the daily diary item craving (“desire to use tobacco”) for the first 14 days following target quit date (TQD) according to treatment group. An asterisk (*) indicates a significant (p ≤ 0.05) difference between treatment groups. The number of subjects with data available ranges from 96 to 104 for bupropion SR and 94 to 107 for placebo.
Fig. 4
Fig. 4
Mean (± SD) weight change (kg) from baseline for subjects that met criteria for prolonged abstinence at the end of the medication phase (49 bupropion SR, 42 placebo). An asterisk (*) indicates a significant (p ≤ 0.05) difference between treatment groups.
See this image and copyright information in PMC

References

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