Effects of 21 days of varenicline versus placebo on smoking behaviors and urges among non-treatment seeking smokers.
Varenicline promotes smoking cessation and reduces urges to smoke. However, the mechanisms associated with these effects and their time course are not well characterized. One mechanism may be extinction, but the duration of the current dosing protocol may not be sufficient. We examined the effect of extended pre-treatment with varenicline on smoking behavior among 17 non-treatment seeking adult smokers. Using a within-subjects, double-blind, placebo-controlled crossover design, participants received standard dosing of varenicline for 21 days, followed by a 14-day washout period and 21 days of placebo; order counterbalanced. Cigarettes per day (CPD), smoking topography, smoking urges (QSU), and side effects were assessed every three days. Biomarkers (e.g. nicotine metabolites) were collected on days 1, 7, and 21. There was a significant drug by time interaction indicating a reduction in CPD during varenicline phase (between days 10-21), but no reduction during placebo. Varenicline also led to reductions in nicotine metabolites and urges to smoke. Among this sample of non-treatment seeking smokers, varenicline significantly reduced smoking behavior. Results have important treatment implications because changes in CPD and craving did not occur until after the typical one-week run-up period. This suggests that a longer duration of pre-treatment may be beneficial for some smokers.
Department of Psychiatry, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.
Rebecca L
RL
Ashare
Kathy Z
KZ
Tang
A Clementina
AC
Mesaros
Ian A
IA
Blair
Frank
F
Leone
Andrew A
AA
Strasser
D000328:Adult; D016739:Behavior, Addictive / Q000209:etiology / Q000517:prevention & control*; D001552:Benzazepines / Q000009:adverse effects / Q000627:therapeutic use*; D015415:Biomarkers / Q000652:urine; D003367:Cotinine / Q000652:urine; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D009538:Nicotine / Q000652:urine; D018722:Nicotinic Agonists / Q000009:adverse effects / Q000627:therapeutic use*; D010342:Patient Acceptance of Health Care; D010414:Pennsylvania; D011810:Quinoxalines / Q000009:adverse effects / Q000627:therapeutic use*; D011978:Receptors, Nicotinic / Q000737:chemistry / Q000378:metabolism; D016540:Smoking Cessation; D013375:Substance Withdrawal Syndrome / Q000503:physiopathology / Q000517:prevention & control* / Q000652:urine; D013997:Time Factors; D000068580:Varenicline; D055815:Young Adult; D064569:alpha7 Nicotinic Acetylcholine Receptor
D001552:Benzazepines; D015415:Biomarkers; C579167:Chrna7 protein, human; D018722:Nicotinic Agonists; D011810:Quinoxalines; D011978:Receptors, Nicotinic; D064569:alpha7 Nicotinic Acetylcholine Receptor; C403531:nicotinic receptor alpha4beta2; D009538:Nicotine; D003367:Cotinine; D000068580:Varenicline