Screening and Baseline Assessments Comprehensive psychiatric assessment (Sheehan et al., 1998, 2010), physical selleck chemical examination, laboratory testing (complete blood count, comprehensive metabolic panel, urine pregnancy test, and urine drug screen), and electrocardiogram were performed. A thorough smoking history was obtained, and baseline nicotine dependence was assessed using the Modified Fagerstr?m Tolerance Questionnaire (Prokhorov et al., 2000) and the Hooked on Nicotine Checklist (DiFranza et al., 2002). Randomization and Treatment Eligible participants in both groups were given quit smoking brochures, instructed to set a quit date within 2 weeks of medication initiation, and randomized to receive an 8-week double-blind course of varenicline or bupropion XL. Varenicline participants ��55 kg received 0.
5 mg daily for 3 days, 0.5 mg twice daily for 4 days, and then 1 mg twice daily thereafter. Those <55 kg received 0.5 mg daily for 7 days and then 0.5 mg twice daily thereafter (Faessel et al., 2009). Bupropion XL participants received 150 mg daily for 7 days and then 300 mg daily thereafter. The university investigational drug service encased medications in identical-appearing capsules and dispensed them in weekly blister packs with specific instructions on day/time for each dose. Placebo capsules were used at times when no active medication was scheduled (i.e., evening dose for participants randomized to bupropion XL, to match evening dose of varenicline). We recognize that this design element undermined the potential adherence advantage of bupropion XL once daily dosing, but judged that maintenance of the treatment blind was of primary importance.
Participants were seen weekly during the 8-week medication trial and returned for posttreatment follow-up assessment at Week 12. At all visits, the study physician provided brief individual cessation counseling (��10 min) and structured safety assessment. Measures Safety A thorough safety evaluation was conducted at each visit (weekly during active treatment): (a) physician evaluation of physical and neuropsychiatric adverse events via open-ended interview and comprehensive, structured review of systems (Kalachnik, 2001), (b) Columbia Suicide Severity Rating Scale (Meyer et al., 2010; Posner et al.
, 2007) and the Beck Depression Inventory II (BDI; Beck, Steer, & Brown, 1996; Subramaniam, Harell, Huntley, & Tracy, 2009) to assess neuropsychiatric events, Cilengitide (c) urine pregnancy testing (females only), and (d) vital sign measurement. Adherence Medication diaries and weekly pill counts (inspection of blister packs and documentation of missed doses) were used to measure adherence. Efficacy Participants completed a 30-day cigarette timeline followback at the assessment visit and daily cigarette diaries (collected weekly) throughout treatment (Harris et al., 2009; Sobell, Sobell, Leo, & Cancilla, 1988).