Major exclusion criteria were current non-nicotine substance abuse or dependence, current mood or anxiety disorders (except specific phobia), lifetime antisocial personality disorder or psychosis, positive screen for illicit drug use, having received pharmacotherapy or behavioral treatment selleck chemicals llc for smoking cessation in the prior 30 days, and having received pharmacotherapy for ADHD in the prior 30 days. Pregnant or breastfeeding women were also excluded. See Table 1 for a description of the sample. All participants provided informed consent, and the study was reviewed and approved by the Institutional Review Boards of the six sites that participated in the trial. Table 1. Sample Demographic and Clinical Characteristics (N = 255)a Assessments The Composite International Diagnostic Interview (Robins et al.
, 1988) was used to determine whether psychiatric inclusion/exclusion criteria were met. ADHD diagnosis was made using the Adult ADHD Clinical Diagnostic Scale (Adler & Spencer, 2004), and severity of ADHD was assessed using the DSM-IV ADHD Rating Scale (DuPaul et al., 1998). The three-item Thoughts About Abstinence scale (Hall, Havassy, & Wasserman, 1991) was administered at baseline to assess desire to quit (i.e., motivation), expected success in quitting (i.e., self-efficacy), and perceived difficulty quitting on a 10-point rating scale. Predictive validity of single-item ratings of these constructs has been established in previous studies (Gwaltney et al., 2009; Hendricks, Delucchi, & Hall, 2010; Shmueli et al., 2008).
Self-reported nicotine patch adherence, calculated by dividing the number of patches reported used by the number dispensed, was utilized as the nicotine patch adherence measure because the data were more complete for this measure than for nicotine patch count. The agreement between self-reported adherence and nicotine patch count was very good. Of 964 comparisons of self-report to nicotine patch count, the self-report and the patch count were consistent for 900 comparisons (e.g., the two measures agreed in 93.4% of the cases). Adherence to counseling was measured in two ways: (a) session attendance, Dacomitinib defined as the percent of scheduled sessions which the participant attended, and (b) average counseling compliance, which was rated by counselors at each visit on a 1 (not at all) to 5 (extremely) scale based on homework completion and session participation. Procedures For a complete description of procedures for the trial, see Winhusen et al. (2010). Briefly, the study was an 11-week, double-blind, placebo-controlled, parallel-group trial of OROS-MPH versus placebo in combination with nicotine patch and counseling as a treatment for smoking cessation in adults with ADHD.