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

Raymond Niaura, Bonnie Spring, Belinda Borrelli, Donald Hedeker, Michael G. Goldstein, Nancy Keuthen, Judy Depue, Jean Kristeller, Judy Ockene, Allan Prochazka, John A. Chiles, David B. Abrams

    Research output: Contribution to journalArticlepeer-review


    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.
    Original languageEnglish
    Pages (from-to)887-896
    Number of pages9
    JournalJournal of Consulting and Clinical Psychology
    Issue number4
    Publication statusPublished - 2002


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