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Randomized Controlled Trial
. 2014 Mar;16(3):288-96.
doi: 10.1093/ntr/ntt141. Epub 2013 Sep 21.

Topiramate for smoking cessation: a randomized, placebo-controlled pilot study

Cheryl Oncken  1 , Albert J Arias, Richard Feinn, Mark Litt, Jonathan Covault, Mehmet Sofuoglu, Henry R Kranzler
Affiliations
Randomized Controlled Trial

Topiramate for smoking cessation: a randomized, placebo-controlled pilot study

Cheryl Oncken et al. Nicotine Tob Res. 2014 Mar.

Abstract

Introduction: Topiramate (TOP) blocks glutamate receptors and facilitates GABA (γ-aminobutyric acid) neurotransmission, effects that may facilitate smoking cessation. We compared the effects of behavioral counseling combined with (a) TOP, (b) TOP/nicotine patch (TOP/NIC), or (c) placebo (PLC) for smoking cessation.

Methods: We conducted a 10-week randomized trial in which subjects and research personnel were blinded to TOP versus PLC but not to the TOP/NIC patch condition. In groups receiving TOP, the medication dosage was titrated gradually up to 200 mg/day. The smoking quit date (QD) was scheduled after 2 weeks of medication treatment. NIC (21 mg) was started on the QD in subjects randomized to the TOP/NIC condition. The main outcome measure was the end-of-treatment, 4-week continuous abstinence rate (CAR; biochemically confirmed).

Results: Fifty-seven subjects were randomized to treatment. The 4-week CAR was 1 of 19 (5%) in the PLC group, 5 of 19 (26%) in the TOP group, and 7 of 19 (37%) in the TOP/NIC group (p = .056). Pairwise comparisons showed a difference between TOP/NIC and PLC (p = .042) and a nonsignificant difference between TOP and PLC (p = .18). The PLC group gained 0.37 lb/week, the TOP group lost 0.41 lb/week, and the TOP/NIC group lost 0.07 lb/week (p = .004). Pairwise comparisons showed a difference between TOP and PLC (p < .001) and between TOP/NIC and PLC groups (p = .035). Paresthesia was more frequent in subjects on TOP than PLC (p = .011).

Conclusions: TOP, alone or in combination with the NIC, resulted in a numerically higher quit rate than PLC and decreased weight. A larger, PLC-controlled trial is needed to confirm these findings.

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Figures

Figure 1.
Figure 1.
Four-week continuous cigarette abstinence rates at the end of treatment. Abstinence rates were determined by self-report and exhaled carbon monoxide measurement.
Figure 2.
Figure 2.
Seven-day point prevalence cigarette abstinence rates throughout the study, confirmed with exhaled carbon monoxide measurement (BL = baseline, TOP = topiramate, TOP/NIC = topiramate and nicotine patch, PLC = placebo).
Figure 3.
Figure 3.
Mean (SD) change in body weight (pounds) in the three treatment groups (TOP = topiramate, TOP/NIC = topiramate and nicotine patch, PLC = placebo).
See this image and copyright information in PMC

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