Individualizing Nicotine Replacement Therapy for the Treatment of Tobacco Dependence

A Randomized Trial

16 March 2004 | Volume 140 Issue 6 | Pages 426-433

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.

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

Setting: 2 university-based smoking cessation research programs.

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

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

Measurements: 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.

Limitations: 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.

Editors' Notes Context Do certain forms of nicotine replacement therapy work better than others and, if so, in whom? Contribution This randomized trial of 299 treatment-seeking smokers found similar 6-month abstinence rates between smokers receiving behavioral counseling and 8 weeks of therapy with either nicotine nasal spray (12%) or transdermal nicotine (15%). Subgroup analyses suggested that highly dependent, obese, and nonwhite smokers achieved higher abstinence rates with nasal spray. Low to moderately dependent, nonobese, and white smokers achieved higher abstinence rates with transdermal nicotine. Cautions Tailoring nicotine replacement therapy on the basis of characteristics of smokers is an intriguing strategy but has not yet been tested. –The Editors

 

Author and Article Information

From University of Pennsylvania, Philadelphia, Pennsylvania; University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania; and University of California, San Francisco, San Francisco, California.

Acknowledgments: The authors thank Christopher Jepson, PhD, E. Paul Wileyto, PhD, and Susan Kucharski for their assistance with database preparation. They also thank Peter Shields, MD, and Shiva Krishnan for assistance with the processing of blood samples and Lita Ramos for performing the plasma cotinine assays.

Grant Support: By Transdisciplinary Tobacco Use Research Center grant P5084718 from the National Cancer Institute and the National Institute on Drug Abuse and Public Health Services Research grant M01-RR0040 from the National Institutes of Health. Dr. Lerman was supported by the Abramson Cancer Center and Annenberg Public Policy Center. Dr. Benowitz was supported by Public Health Services grants DA02277, DA12393, and CA078703, as well as the University of California, San Francisco, Comprehensive Cancer Center. Nicotine nasal spray (Nicotrol) was provided by Pharmacia and Upjohn, Helsingborg, Sweden.

Potential Financial Conflicts of Interest:Consultancies: N. Benowitz (GlaxoSmithKline); Grants received: C. Lerman (National Cancer Institute), N. Benowitz (GlaxoSmithKline).

Requests for Single Reprints: Caryn Lerman, PhD, University of Pennsylvania Transdisciplinary Tobacco Use Research Center, 3535 Market Street, Suite 4100, Philadelphia, PA 19104.

Current Author Addresses: Drs. Lerman, Rukstalis, and Audrain-McGovern, Ms. Kaufmann, and Ms. Patterson: Department of Psychiatry, University of Pennsylvania, 3535 Market Street, Suite 4100, Philadelphia, PA 19104.

Dr. Perkins: Department of Psychiatry, Western Psychiatric Institute and Clinic, University of Pittsburgh School of Medicine, 3811 O'Hara Street, Pittsburgh, PA 15213.

Dr. Benowitz: Department of Psychiatry and Biopharmaceutical Sciences, University of California, San Francisco, Box 1220, San Francisco, CA 94143-1220.

Author Contributions: Conception and design: C. Lerman, K. Perkins.

Analysis and interpretation of the data: C. Lerman, M. Rukstalis, K. Perkins, N. Benowitz.

Drafting of the article: C. Lerman, V. Kaufmann, M. Rukstalis, F. Patterson, K. Perkins, J. Audrain-McGovern, N. Benowitz.

Critical revision of the article for important intellectual content: V. Kaufmann, M. Rukstalis, F. Patterson, K. Perkins, J. Audrain-McGovern, N. Benowitz.

Final approval of the article: M. Rukstalis, K. Perkins, N. Benowitz.

Provision of study materials or patients: M. Rukstalis.

Statistical expertise: C. Lerman, K. Perkins.

Obtaining of funding: C. Lerman.

Collection and assembly of data: V. Kaufmann, F. Patterson.