Urine cotinine-verified 7-day point prevalence abstinence was assessed at each study visit beyond the scheduled U0126 ERK quit date. Analyses The pilot nature of the protocol precluded powered statistical analyses of safety or efficacy. Results are thus generally descriptive in nature. Nonetheless, generalized estimating equations (GEE) were used to assess for time effects on secondary outcomes of smoking behavior (CPD, abstinence). Given (a) the study��s small sample, (b) our secondary focus on efficacy, and (c) no placebo control group, we did not anticipate any medication effects or time �� medication interactions. CPD and medication adherence were calculated only among participants retained in the study at each corresponding time point.
Results Participants Twenty-nine participants (age range 15�C20 years) enrolled over an 8-month recruitment period and were randomized to treatment (15 to varenicline and 14 to bupropion XL). Sample characteristics are detailed in Table 1. There were no significant differences between treatment groups among these variables. Table 1. Participant Baseline Characteristics Safety There were no FDA-defined serious adverse events in either treatment group. None of the varenicline participants discontinued medication. One participant randomized to bupropion XL discontinued medication due to increased anxiety and another discontinued due to ��feeling too focused.�� Adverse events occurring in more than one varenicline participant included insomnia (4), nausea (3), and headache (2).
Adverse events occurring in more than one bupropion XL participant included vivid dreams (5), insomnia (2), nausea (2), and chest discomfort (2). No suicidal behavior or ideation was observed in either treatment group, and no participants reported clinically significant depressive symptoms on BDI. Adherence Varenicline participants took 80% of dispensed doses, and bupropion XL participants took 79% of dispensed doses. Efficacy Smoking outcomes (CPD, abstinence by week) are detailed in Table 2. GEE analysis revealed significant (p < .01) time effects for both outcomes over the course of treatment and as expected no significant treatment (varenicline vs. bupropion XL) effects or interactions. Table 2. Smoking Outcomes, by Study Cilengitide Week Discussion Results of this preliminary pilot trial support the feasibility and safety of conducting older adolescent smoking cessation trials with varenicline and bupropion XL. While both medications carry FDA ��black box warnings�� related to potential neuropsychiatric adverse effects, they were generally well tolerated and were not associated with depressive symptoms or suicidality as assessed by comprehensive, validated evaluation methods.