Comparative efficacy of 24-hour and 16-hour transdermal nicotine patches for relief of morning craving.
OBJECTIVE
To compare a transdermal nicotine patch designed for 24-hour wear with one designed for 16-hour wear for relief of craving and withdrawal, particularly in the morning hours.


METHODS
Smokers were randomly assigned to use one of two common patch regimens: NicoDerm/NiQuitin (24-hour wear, 21 mg nicotine) or Nicotrol/Nicorette (16-hour wear, 15 mg). In a double-dummy design, participants wore two patches during the day, one active, one placebo and one patch while sleeping.


METHODS
A smoking cessation research clinic.


METHODS
Two hundred and forty-four smokers who suffered morning cravings.


METHODS
Two patch formulations approved and marketed for over-the-counter use in the US--NicoDerm CQ (labeled as 21 mg over 24 hours) and Nicotrol (labeled as 15 mg over 16 hours)--were each used according to its instructions. Smokers also received behavioral counseling.


METHODS
For a week of baseline and 2 weeks after quitting, smokers used palm-top computers to assess craving and withdrawal symptoms several times each day.


RESULTS
The 21 mg/24-hour patch yielded consistently better control of craving, not only during the morning hours, but throughout the day, and over the 2-week period of abstinence. Additionally, the 21 mg/24-hour patch yielded greater reductions in anxiety, irritability and restlessness. Smokers using the 21 mg/24-hour dosing regimen also experienced longer abstinence than those using the 15 mg/16-hour patch.


CONCLUSIONS
These findings demonstrate that 24-hour dosing with a 21 mg patch affords superior relief of craving and withdrawal during the first 2 weeks of abstinence, when symptoms are at their peak, and when relapse is most likely. They confirm the importance of dosing parameters in nicotine replacement products.
Shiffman
S
S
University of Pittsburgh, Smoking Research Group, PA 15260, USA.
Elash
C A
CA
Paton
S M
SM
Gwaltney
C J
CJ
Paty
J A
JA
Clark
D B
DB
Liu
K S
KS
Di Marino
M E
ME
D000279:Administration, Cutaneous; D000328:Adult; D000704:Analysis of Variance; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D008838:Microcomputers; D008875:Middle Aged; D009538:Nicotine / Q000008:administration & dosage* / Q000627:therapeutic use; D018722:Nicotinic Agonists / Q000008:administration & dosage* / Q000627:therapeutic use; D016540:Smoking Cessation / Q000379:methods* / Q000523:psychology; D018709:Statistics, Nonparametric; D013375:Substance Withdrawal Syndrome / Q000188:drug therapy* / Q000523:psychology
D018722:Nicotinic Agonists; D009538:Nicotine