TY - JOUR
T1 - Transdermal Nicotine for Smoking Cessation
T2 - Six-Month Results From Two Multicenter Controlled Clinical Trials
AU - Transdermal Nicotine Study Group
AU - Allen, Sharon S
N1 - Copyright:
Copyright 2015 Elsevier B.V., All rights reserved.
PY - 1991/12/11
Y1 - 1991/12/11
N2 - Objective.—To evaluate the efficacy of a new transdermal nicotine system for smoking cessation. Design.—Two 6-week, randomized, double-blind, placebo-controlled, parallel group trials were conducted. Successful abstainers from both trials enrolled in a third trial for blinded downtitration from medications (6 weeks) and subsequent off-drug follow-up (12 weeks). Setting.—Nine outpatient clinics specializing in the treatment of smoking cessation. Patients.—Healthy volunteers who smoked one or more packs of cigarettes daily and wanted to participate in a smoking cessation program. Intervention.—Patients were randomly assigned to a transdermal nicotine system delivering nicotine at rates of 21,14, or 7 mg (in trial 1 only) over 24 hours or to placebo. Group counseling sessions were provided to all participants. Main Outcome Measure.—Rates of continuous smoking abstinence were determined during 6 weeks of full-dose treatment, a 6-week weaning period (through week 12), and a 3-month follow-up receiving no therapy (through week 24). Abstinence was defined by patient diary reports of no smoking during the designated periods, confirmed by expired-breath carbon monoxide levels of 8 ppm or lower. Results.—The centers enrolled 935 patients. Cessation rates during the last 4 weeks of the two 6-week trials (pooled data) were 61%, 48%, and 27% for 21-and 14-mg transdermal nicotine and placebo, respectively (P≤.001 for each active treatment vs placebo). Six-month abstinence rates for 21-mg transdermal nicotine and placebo were 26% and 12%, respectively (P≤.001). All transdermal nicotine doses significantly decreased the severity of nicotine withdrawal symptoms and significantly reduced cigarette use by patients who did not stop smoking. Compliance was excellent, and no serious systemic adverse effects were reported. Conclusions.—Transdermal nicotine systems show considerable promise as an aid to smoking cessation.
AB - Objective.—To evaluate the efficacy of a new transdermal nicotine system for smoking cessation. Design.—Two 6-week, randomized, double-blind, placebo-controlled, parallel group trials were conducted. Successful abstainers from both trials enrolled in a third trial for blinded downtitration from medications (6 weeks) and subsequent off-drug follow-up (12 weeks). Setting.—Nine outpatient clinics specializing in the treatment of smoking cessation. Patients.—Healthy volunteers who smoked one or more packs of cigarettes daily and wanted to participate in a smoking cessation program. Intervention.—Patients were randomly assigned to a transdermal nicotine system delivering nicotine at rates of 21,14, or 7 mg (in trial 1 only) over 24 hours or to placebo. Group counseling sessions were provided to all participants. Main Outcome Measure.—Rates of continuous smoking abstinence were determined during 6 weeks of full-dose treatment, a 6-week weaning period (through week 12), and a 3-month follow-up receiving no therapy (through week 24). Abstinence was defined by patient diary reports of no smoking during the designated periods, confirmed by expired-breath carbon monoxide levels of 8 ppm or lower. Results.—The centers enrolled 935 patients. Cessation rates during the last 4 weeks of the two 6-week trials (pooled data) were 61%, 48%, and 27% for 21-and 14-mg transdermal nicotine and placebo, respectively (P≤.001 for each active treatment vs placebo). Six-month abstinence rates for 21-mg transdermal nicotine and placebo were 26% and 12%, respectively (P≤.001). All transdermal nicotine doses significantly decreased the severity of nicotine withdrawal symptoms and significantly reduced cigarette use by patients who did not stop smoking. Compliance was excellent, and no serious systemic adverse effects were reported. Conclusions.—Transdermal nicotine systems show considerable promise as an aid to smoking cessation.
UR - http://www.scopus.com/inward/record.url?scp=0026353183&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=0026353183&partnerID=8YFLogxK
U2 - 10.1001/jama.1991.03470220049025
DO - 10.1001/jama.1991.03470220049025
M3 - Article
C2 - 1956099
AN - SCOPUS:0026353183
SN - 0098-7484
VL - 266
SP - 3133
EP - 3138
JO - JAMA: The Journal of the American Medical Association
JF - JAMA: The Journal of the American Medical Association
IS - 22
ER -