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Sensitivity and specificity of a procedure for early human screening of novel smoking cessation medications
Author(s) -
Perkins Kenneth A.,
Lerman Caryn,
Karelitz Joshua L.,
Jao Nancy C.,
Chengappa K. N. Roy,
Sparks Garrett M.
Publication year - 2013
Publication title -
addiction
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.424
H-Index - 193
eISSN - 1360-0443
pISSN - 0965-2140
DOI - 10.1111/add.12273
Subject(s) - bupropion , modafinil , abstinence , medicine , smoking cessation , varenicline , placebo , nicotine patch , anesthesia , nicotine , psychiatry , alternative medicine , pathology
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 the efficacy of bupropion and identify correctly the lack of efficacy of modafinil. Design Using a within‐subject double cross‐over design, smokers attempted to quit during each treatment, with bupropion (150 mg b.i.d.), modafinil [100 mg twice daily (b.i.d.)] or placebo (double‐blind, counterbalanced 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 U nited S tates. 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 hours and carbon monoxide ( CO) < 5 parts per million. Findings Compared with placebo, bupropion did ( F (1,44) = 6.98, P = 0.01), but modafinil did not ( F (1,44) = 0.29, P = 0.60), 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 versus four), Z = 2.11, P < 0.05, while modafinil did not (six). 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 versus not useful in aiding smoking cessation.