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Multicenter trial of fluoxetine as an adjunct to behavioral smoking cessation treatment

Raymond Niaura
Bonnie Spring
Belinda Borrelli
Donald Hedeker
Michael G. Goldstein
Nancy J. Keuthen
Judy DePue
Jean L. Kristeller
Judith K. Ockene, University of Massachusetts Medical School
Allan Prochazka
John A. Chiles
David B. Abrams

Abstract

The authors evaluated the efficacy of fluoxetine hydrochloride (Prozac; Eli Lilly and Company, Indianapolis, IN) as an adjunct to behavioral treatment for smoking cessation. Sixteen sites randomized 989 smokers to 3 dose conditions: 10 weeks of placebo, 30 mg, or 60 mg fluoxetine per day. Smokers received 9 sessions of individualized cognitive-behavioral therapy, and biologically verified 7-day self-reported abstinence follow-ups were conducted at 1, 3, and 6 months posttreatment. Analyses assuming missing data counted as smoking observed no treatment difference in outcomes. Pattern-mixture analysis that estimates treatment effects in the presence of missing data observed enhanced quit rates associated with both the 60-mg and 30-mg doses. Results support a modest, short-term effect of fluoxetine on smoking cessation and consideration of alternative models for handling missing data.

Suggested Citation

Raymond Niaura, Bonnie Spring, Belinda Borrelli, Donald Hedeker, Michael G. Goldstein, Nancy J. Keuthen, Judy DePue, Jean L. Kristeller, Judith K. Ockene, Allan Prochazka, John A. Chiles, and David B. Abrams. "Multicenter trial of fluoxetine as an adjunct to behavioral smoking cessation treatment" Journal of consulting and clinical psychology 70.4 (2002).
Available at: http://works.bepress.com/ockenej/28