Topiramate for smoking cessation: a randomized, placebo-controlled pilot study.
BACKGROUND
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.
Department of Medicine and Obstetrics and Gynecology, University of Connecticut Health Center, Farmington, CT;
Cheryl
C
Oncken
Albert J
AJ
Arias
Richard
R
Feinn
Mark
M
Litt
Jonathan
J
Covault
Mehmet
M
Sofuoglu
Henry R
HR
Kranzler
D000328:Adult; D001835:Body Weight / Q000187:drug effects; D003376:Counseling; D005260:Female; D005632:Fructose / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D016540:Smoking Cessation / Q000379:methods* / Q000523:psychology; D061485:Tobacco Use Cessation Devices; D000077236:Topiramate; D016896:Treatment Outcome
D000077236:Topiramate; D005632:Fructose