Over-the-counter nicotine patch therapy for smoking cessation: results from randomized, double-blind, placebo-controlled, and open label trials.
OBJECTIVE
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.
Hays
J T
JT
Mayo Clinic, Rochester, MN 55905, USA. hays.taylor@mayo.edu
Croghan
I T
IT
Schroeder
D R
DR
Offord
K P
KP
Hurt
R D
RD
Wolter
T D
TD
Nides
M A
MA
Davidson
M
M
D000279:Administration, Cutaneous; D000328:Adult; D002248:Carbon Monoxide / Q000378:metabolism; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009538:Nicotine / Q000008:administration & dosage / Q000627:therapeutic use*; D004366:Nonprescription Drugs / Q000008:administration & dosage / Q000627:therapeutic use*; D012107:Research Design; D016540:Smoking Cessation / Q000379:methods*; D016896:Treatment Outcome
D004366:Nonprescription Drugs; D009538:Nicotine; D002248:Carbon Monoxide