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 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 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.
RCT Entities:
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 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 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.
Authors: Bryan W Heckman; Matthew J Carpenter; John B Correa; Jennifer M Wray; Michael E Saladin; Brett Froeliger; David J Drobes; Thomas H Brandon Journal: Addiction Date: 2015-05 Impact factor: 6.526
Authors: Kenneth A Perkins; K N Roy Chengappa; Joshua L Karelitz; Margaret C Boldry; Valerie Michael; Taylor Herb; Jessica Gannon; Jaspreet Brar; Lisa Ford; Stefanie Rassnick; Darlene H Brunzell Journal: Neuropsychopharmacology Date: 2017-11-29 Impact factor: 7.853
Authors: Kenneth A Perkins; Joshua L Karelitz; Valerie C Michael; Margaret Fromuth; Cynthia A Conklin; K N Roy Chengappa; Chris Hope; Caryn Lerman Journal: Nicotine Tob Res Date: 2015-04-20 Impact factor: 4.244
Authors: Mary Falcone; Leah Bernardo; E Paul Wileyto; Cheyenne Allenby; Anne Marie Burke; Roy Hamilton; Mario Cristancho; Rebecca L Ashare; James Loughead; Caryn Lerman Journal: Drug Alcohol Depend Date: 2018-11-13 Impact factor: 4.492
Authors: Kelly E Dunn; Andrew S Huhn; Cecilia L Bergeria; Cassandra D Gipson; Elise M Weerts Journal: J Pharmacol Exp Ther Date: 2019-08-07 Impact factor: 4.030