TY - JOUR
T1 - Over-the-counter nicotine patch therapy for smoking cessation
T2 - Results from randomized, double-blind, placebo-controlled, and open label trials
AU - Hays, J. Taylor
AU - Croghan, Ivana T.
AU - Schroeder, Darrell R.
AU - Offord, Kenneth P.
AU - Hurt, Richard D.
AU - Wolter, Troy D.
AU - Nides, Mitchell A.
AU - Davidson, Michael
PY - 1999/11
Y1 - 1999/11
N2 - Objectives. The purpose of this study was to determine the efficacy and safety of the nicotine patch for smoking cessation in an over-the-counter environment. The years of study were 1994 to 1995. Methods. Parallel 6-week trials were conducted: a placebo-controlled trial of no-cost 22-mg, 24-hour nicotine patch therapy and an open label trial of the same therapy with patches purchased by subjects. Participants (n = 958) were 18 years or older, had smoked at least 15 cigarettes daily for at least 6 months, and were enrolled at 3 study sites. The main outcome measure was self-reported smoking abstinence confirmed by expired carbon monoxide measurements. Results. Smoking cessation rates in the placebo-controlled trial were 16.8% and 9.6% at week 6 and 8.7% and 4.3% at week 24 for the active patch and placebo groups, respectively. Smoking cessation rates in the open label-pay trial were 19.0% and 10.8% at weeks 6 and 24, respectively. A slight increase in adverse cardiovascular events was noted only in the open label-pay group in comparison with the placebo group. Conclusions. In an over-the-counter environment, the 22-mg, 24-hour nicotine patch is effective and safe for smoking cessation treatment.
AB - Objectives. The purpose of this study was to determine the efficacy and safety of the nicotine patch for smoking cessation in an over-the-counter environment. The years of study were 1994 to 1995. Methods. Parallel 6-week trials were conducted: a placebo-controlled trial of no-cost 22-mg, 24-hour nicotine patch therapy and an open label trial of the same therapy with patches purchased by subjects. Participants (n = 958) were 18 years or older, had smoked at least 15 cigarettes daily for at least 6 months, and were enrolled at 3 study sites. The main outcome measure was self-reported smoking abstinence confirmed by expired carbon monoxide measurements. Results. Smoking cessation rates in the placebo-controlled trial were 16.8% and 9.6% at week 6 and 8.7% and 4.3% at week 24 for the active patch and placebo groups, respectively. Smoking cessation rates in the open label-pay trial were 19.0% and 10.8% at weeks 6 and 24, respectively. A slight increase in adverse cardiovascular events was noted only in the open label-pay group in comparison with the placebo group. Conclusions. In an over-the-counter environment, the 22-mg, 24-hour nicotine patch is effective and safe for smoking cessation treatment.
UR - http://www.scopus.com/inward/record.url?scp=0032706049&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=0032706049&partnerID=8YFLogxK
U2 - 10.2105/AJPH.89.11.1701
DO - 10.2105/AJPH.89.11.1701
M3 - Article
C2 - 10553392
AN - SCOPUS:0032706049
SN - 0090-0036
VL - 89
SP - 1701
EP - 1707
JO - American journal of public health
JF - American journal of public health
IS - 11
ER -