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A Randomized, Controlled Trial

Steven A. Ornish, MD; Sidney Zisook, MD; Lou Ann McAdams, PhD

Arch Intern Med. 1988;148(9):2027-2031.

Abstract
• In a double-blind, randomized, placebo-controlled trial, we studied 40 cigarette smokers to determine the effects of one week of transdermal clonidine hydrochloride (Catapres-TTS No. 2) treatment on the withdrawal symptoms associated with smoking cessation. Subjects were instructed to maintain their usual cigarette intake during days 1 through 3 and cease smoking for days 4 through 6. All of the withdrawal symptoms measured (craving, irritability, anxiety, restlessness, difficulty concentrating, and hunger) significantly increased during the three days of smoking cessation in the placebo group. There was a 4.3-fold increase in craving, a 3.8-fold increase in irritability, a 3.7-fold increase in anxiety, and a 3.3-fold increase in restlessness in the placebo group compared with the transdermal clonidine group during the three days of smoking cessation. Impairment of concentration and hunger were not significantly diminished by transdermal clonidine treatment during smoking cessation. In addition, a trend was present in the transdermal clonidine group to spontaneously decrease the number of cigarettes smoked per day during the smoking period. Side effects were generally mild. We conclude that transdermal clonidine treatment ameliorates some of the short-term withdrawal symptoms, especially craving, associated with smoking cessation.

(Arch Intern Med 1988;148:2027-2031)

Author Affiliations
From the Department of Psychiatry, University of California, San Diego, School of Medicine. Dr Ornish is currently in private practice.

Footnotes
Accepted for publication May 5, 1988.

Reprint requests to Psychiatric Services, University of California, San Diego, 3424 Fourth Ave, San Diego, CA 92103 (Dr Zisook).

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