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A Placebo Controlled Trial of Nicotine Polacrilex and Self-directed Relapse Prevention: Initial Results of the Stanford Stop Smoking Project

Stephen P. Fortmann, MD; Joel D. Killen, PhD; Michael J. Telch, PhD; Barbara Newman, MA

JAMA. 1988;260(11):1575-1580.

Abstract
To determine the effectiveness of nicotine polacrilex combined with self-administered relapse prevention materials in maintaining smoking cessation, we conducted a randomized, double-blind, placebo controlled trial. Volunteers aged 18 to 65 years responding to media announcements were required to quit smoking for 48 hours without assistance. Of 1844 potential participants, 136 were medically excluded, 535 declined to make a quit attempt, and 573 were unable to quit, leaving 600 participants (35%) who were randomized. Eight self-help relapse prevention modules were mailed weekly. Gum was used either ad lib for smoking urges or on a fixed, hourly schedule (12 pieces per day). Only 15% of the subjects in each gum group stopped using the gum altogether because of side effects, but only 20% of the ad lib groups and 40% of the fixed-dosage group used at least eight pieces of gum per day during the first week. The abstinence rates (for at least seven days) at the six-month follow-up were 31% in both active gum groups and 22% in the placebo and no gum groups. Relapse rates in the two active gum groups were about half those in the placebo and no gum groups. Nicotine polacrilex may be a useful adjunct to minimal contact smoking cessation formats, which have broad appeal. Also, minimal contact relapse prevention programs may assist physicians in helping patients to maintain smoking cessation using nicotine polacrilex.

(JAMA 1988;260:1575-1580)

Author Affiliations
From the Center for Research in Disease Prevention and the Division of General Internal Medicine, Stanford (Calif) University School of Medicine. Dr Teich is now with the Department of Psychology, University of Texas, Austin.

Footnotes
Reprint requests to Center for Research in Disease Prevention, Stanford University School of Medicine, 1000 Welch Rd, Palo Alto, CA 94304-1885 (Dr Fortmann).

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