Individualizing nicotine replacement therapy for the treatment of tobacco dependence: a randomized trial.
BACKGROUND
Despite the well-documented efficacy and different pharmacokinetic and pharmacodynamic properties of different forms of nicotine replacement therapy, empirical data are insufficient to guide practitioners in selecting a particular form of treatment for individual patients with tobacco dependence.


OBJECTIVE
To evaluate the comparative efficacy of transdermal nicotine and nicotine nasal spray and identify predictors of treatment outcome.


METHODS
Randomized, open-label clinical trial with a 6-month follow-up period.


METHODS
2 university-based smoking cessation research programs.


METHODS
299 treatment-seeking smokers who were followed for 6 months after the target quit date.


METHODS
Behavioral group counseling and 8 weeks of therapy with nicotine nasal spray or transdermal nicotine.


METHODS
Demographic characteristics, smoking history, depression symptoms, and body mass index were measured at baseline. Smoking practices were biochemically verified at the end of treatment and at 6 months after the target quit date.


RESULTS
Abstinence rates for the transdermal nicotine and nicotine nasal spray groups were not significantly different at 6-month follow-up (15.0% vs. 12.2%, respectively; P > 0.2). Interactions in abstinence rates for subgroups of smokers were statistically significant (P < 0.05). Smokers who had low to moderate dependence levels, were not obese, and were white achieved higher abstinence rates with transdermal nicotine, whereas smokers who were highly dependent, obese, or members of minority groups achieved higher abstinence rates with nasal spray.


CONCLUSIONS
The subgroup findings need confirmation in additional large studies before they are routinely applied.


CONCLUSIONS
Ethnicity, weight, and level of nicotine dependence may help identify smokers who have greater or lesser abstinence rates with either transdermal or nasal spray nicotine.
Lerman
Caryn
C
Department of Psychiatry, University of Pennsylvania, Philadelphia, Pennsylvania 19104, USA.
Kaufmann
Vyga
V
Rukstalis
Margaret
M
Patterson
Freda
F
Perkins
Kenneth
K
Audrain-McGovern
Janet
J
Benowitz
Neal
N
D000279:Administration, Cutaneous; D000281:Administration, Intranasal; D000328:Adult; D001521:Behavior Therapy; D003367:Cotinine / Q000627:therapeutic use; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009538:Nicotine / Q000008:administration & dosage*; D009765:Obesity / Q000150:complications; D016540:Smoking Cessation / Q000379:methods*; D012959:Socioeconomic Factors; D014029:Tobacco Use Disorder / Q000150:complications / Q000188:drug therapy* / Q000208:ethnology; D016896:Treatment Outcome
D009538:Nicotine; D003367:Cotinine