Sensitivity and Specificity of A Procedure for Early Human Screening of Novel Smoking Cessation Medications by Perkins Kenneth A, Lerman Caryn, Karelitz Joshua L, Jao Nancy C, Chengappa K N Roy, Sparks Garrett M in Addiction (Abingdon, England) (2013). PubMed

Abstract

BACKGROUND AND AIM: It is important to find economical methods in early Phase 2 studies to screen drugs potentially useful to aid smoking cessation. A method has been developed that detects efficacy of varenicline and nicotine patch. This study aimed to evaluate whether the method would detect efficacy of bupropion and correctly identify lack of efficacy of modafinil. DESIGN: Using a within-subject double crossover design, smokers attempted to quit during each treatment, with bupropion (150 mg b.i.d.), modafinil (100 mg b.i.d.), or placebo (double-blind, counter-balanced order). In each of three medication periods, all smoked with no drug on week 1 (baseline or washout), began dose run-up on week 2, and tried to quit every day during week 3. SETTING: A university research center in the United States. PARTICIPANTS: Forty-five adult smokers high in quit interest. MEASUREMENTS: Abstinence was verified daily each quit week by self-report of no smoking over the prior 24 hr and CO<5 ppm. FINDINGS: Compared with placebo, bupropion did (F(1,44)=6.98, p=.01), but modafinil did not (F(1,44)=.29, p=.60), increase the number of abstinent days. Also, bupropion (versus placebo) significantly increased the number of those able to maintain continuous abstinence on all 5 days throughout the quit week (11 vs 4), Z= 2.11, p <.05, while modafinil did not (6). CONCLUSIONS: Assessing days abstinent during 1 week of use of medication versus placebo in a cross-over design could be a useful early Phase 2 study design for discriminating between medications useful vs not useful in aiding smoking cessation.

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