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Individualizing Nicotine Replacement Therapy for the Treatment of Tobacco Dependence: A Randomized Trial

Caryn Lerman, PhD; Vyga Kaufmann, MA; Margaret Rukstalis, MD; Freda Patterson, MS; Kenneth Perkins, PhD; Janet Audrain-McGovern, PhD; and Neal Benowitz, MD
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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.

Ann Intern Med. 2004;140(6):426-433. doi:10.7326/0003-4819-140-6-200403160-00009
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Participants were enrolled at Georgetown University (Washington, DC) and the University of Pennsylvania (Philadelphia, Pennsylvania). The institutional review boards from both universities approved the research procedures. Figure 1 shows the flow of participants through the enrollment, treatment, and follow-up phases of the trial.

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Grahic Jump Location
Figure 1.
Flow diagram of trial participation.

SCID = severe combined immunodeficiency disease.

Grahic Jump Location
Grahic Jump Location
Figure 2.
Six-month prolonged abstinence rates for treatment group by ethnicity, body mass index, and nicotine dependence.
Grahic Jump Location




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Summary for Patients

Matching Nicotine Replacement Treatment to Particular Smokers

The summary below is from the full report titled “Individualizing Nicotine Replacement Therapy for the Treatment of Tobacco Dependence. A Randomized Trial.” It is in the 16 March 2004 issue of Annals of Internal Medicine (volume 140, pages 426-433). The authors are C. Lerman, V. Kaufmann, M. Rukstalis, F. Patterson, K. Perkins, J. Audrain-McGovern, and N. Benowitz.


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