Reduction of abstinence-induced withdrawal and craving using high-dose nicotine replacement therapy

Rationale Decreasing withdrawal and craving during smoking cessation is a major aim of cessation medications. Prior studies have shown that Nicotine Replacement Therapy (NRT) decreases withdrawal symptom severity but have relied on retrospective reports and lacked robust measures of baseline symptoms or symptoms during unmedicated abstinence. Objectives and methods We tested the effect of high-dose (35 mg) nicotine patch on withdrawal and craving during abstinence using real-time assessment with electronic diaries during ad libitum smoking, a brief period of experimentally directed trial abstinence, and the first 3 days of cessation. Subjects were 324 smokers randomized to high-dose nicotine patches or placebo. Results Treatment with active patches reduced withdrawal and craving during cessation and completely eliminated deprivation-related changes in affect or concentration. Conclusion High-dose NRT reduces withdrawal symptoms and craving and can eliminate some symptoms entirely. Saul Shiffman and Stuart Ferguson consult exclusively for GlaxoSmithKline Consumer Healthcare on matters relating to existing smoking cessation products. Dr. Shiffman also has an interest in a new smoking cessation product, and is a founder of invivodata, inc., which provides electronic diaries for clinical trials.