Self-reported abstinence from smoking was assessed using the Timeline Followback (Fals-Stewart et al., 2000) method at each weekly visit and verified with CO measurements of <8 ppm. The Withdrawal Scale for Tobacco (WST), a modification of the Minnesota Nicotine Withdrawal Scale (Hughes and Hatsukami, 1986), was used to assess severity of Bicalutamide Casodex nicotine withdrawal symptoms. The WST lists each withdrawal symptom and asks participants to rate their experience over 24hr prior to each weekly study visit on a 5-point scale from 0 (none) to 4 (Severe). For the purpose of this study, we used only the Hunger item from the WST. Procedures For a complete description of procedures for the randomized controlled trial, see Winhusen et al. (2010).
Briefly, the study was an 11-week, double-blind, placebo-controlled, parallel-group, multisite trial of OROS-MPH versus placebo (assigned in a 1:1 ratio, using computer-generated, site-stratified randomization), both of which were offered in combination with transdermal NRT and counseling, as a treatment for smoking cessation in adults with ADHD (N = 255). OROS-MPH was titrated to a maximum of 72mg/day over the first 2 weeks of the study and continued at the maximum tolerated dose until the end of the active treatment period (Week 11). All participants received brief weekly individual smoking-cessation counseling for 11 weeks and 21mg/day nicotine patch starting on the smoking quit day (Day 27) through study week 11. The primary efficacy endpoint for smoking cessation was prolonged abstinence during study weeks 7�C10 of the trial, which allowed a 2-week grace period after the target quit date.
Prolonged abstinence was defined as a self-report of not smoking either (a) once per day for seven consecutive days or (b) at least once per week for two consecutive weeks (Hughes, 2003) during study weeks 7�C10. As noted previously, the main outcome of the trial suggested no effect of OROS-MPH on prolonged abstinence (Winhusen et al., 2010). The two dependent variables in our analyses were percent weight change and hunger. Because assessments of weight were conducted only at three points during the trial (i.e., baseline, Week 6, and Week 11), only the study participants (n = 215) who completed the active treatment phase of the study were included in this analysis, as we determined that the time from baseline to the Week 6 study visit (i.e., less than 2 weeks after the target quit GSK-3 date) was not a sufficient period over which to capture OROS-MPH��s effects on weight gain during a quit attempt. Thus, our primary measure of weight change was the percent change in body weight between baseline and Week 11 (i.e., end of active treatment phase).