Multicenter trial of fluoxetine as an adjunct to behavioral smoking cessation treatment.
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.
Centers for Behavioral and Preventive Medicine, The Miriam Hospital and Brown Medical School, Providence, Rhode Island 02903, USA. raymond_niaura@brown.edu
Raymond
R
Niaura
Bonnie
B
Spring
Belinda
B
Borrelli
Donald
D
Hedeker
Michael G
MG
Goldstein
Nancy
N
Keuthen
Judy
J
DePue
Jean
J
Kristeller
Judy
J
Ockene
Allan
A
Prochazka
John A
JA
Chiles
David B
DB
Abrams
D000328:Adult; D001521:Behavior Therapy / Q000379:methods*; D003131:Combined Modality Therapy; D004311:Double-Blind Method; D005260:Female; D005473:Fluoxetine / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D017367:Selective Serotonin Reuptake Inhibitors / Q000627:therapeutic use*; D016540:Smoking Cessation; D000074606:Smoking Prevention
D005473:Fluoxetine; D017367:Selective Serotonin Reuptake Inhibitors