Rd. Hurt et al., A COMPARISON OF SUSTAINED-RELEASE BUPROPION AND PLACEBO FOR SMOKING CESSATION, The New England journal of medicine, 337(17), 1997, pp. 1195-1202
Background and Methods Trials of antidepressant medications for smokin
g cessation have had mixed results. We conducted a double-blind, place
bo-controlled trial of a sustained-release form of bupropion for smoki
ng cessation. We excluded smokers with current depression, but not tho
se with a history of major depression. The 615 subjects were randomly
assigned to receive placebo or bupropion at a dose of 100, 150, or 300
mg per day for seven weeks. The target quitting date (or ''target qui
t date'') was one week after the beginning of treatment. Brief counsel
ing was provided at base line, weekly during treatment, and at 8, 12,
26, and 52 weeks. Self-reported abstinence was confirmed by a carbon m
onoxide concentration in expired air of 10 ppm or less. Results At the
end of seven weeks of treatment, the rates of smoking cessation as co
nfirmed by carbon monoxide measurements were 19.0 percent in the place
bo group, 28.8 percent in the 100-mg group, 38.6 percent in the 150-mg
group, and 44.2 percent in the 300-mg group (P<0.001). At one year th
e respective rates were 12.4 percent, 19.6 percent, 22.9 percent, and
23.1 percent. The rates for the 150-mg group (P=0.02) and the 300-mg g
roup (P=0.01) but not the 100-mg group (P=0.09) - were significantly b
etter than those for the placebo group. Among the subjects who were co
ntinuously abstinent through the end of treatment, the mean absolute w
eight gain was inversely associated with the dose (a gain of 2.9 kg in
the placebo group, 2.3 kg in 100-mg and 150-mg groups, and 1.5 kg in
the 300-mg group; P=0.02). No effects of treatment were observed on de
pression scores as measured serially by the Beck Depression inventory.
Thirty-seven subjects stopped treatment prematurely because of advers
e events; the frequency was similar among all groups. Conclusions A su
stained-release form of bupropion was effective for smoking cessation
and was accompanied by reduced weight gain and minimal side effects. M
any participants in all groups were smoking at one year. (C) 1997, Mas
sachusetts Medical Society.