OUTCOMES RESEARCH IN REVIEW Study Overview

Objective. To determine the value of adding nortriptyline hydrochloride to a smoking cessation program. Design. Randomized, double-blind, placebo-controlled trial. Setting and participants. 214 patients were enrolled in the study. Enrollees smoked 10 or more cigarettes per day, were between 18 and 70 years of age, were without current major depression, and were participating in a smoking cessation behavioral intervention program conducted at an affiliated Department of Veterans Affairs Medical Center and an Army Medical Center in Colorado. Methods. Patients were begun on nortriptyline (n = 108) or matched placebo (n = 106) at 25 mg before bed 10 days prior to quit day and titrated to 75 mg/day or to the maximal tol-erated dose. The behavioral intervention consisted of two group sessions and 12 individual follow-up visits, based o