Heavy cigarette smoking has caused a global public health disaster. Smoking causes premature morbidity, disability, and mortality; and places extraordinary burdens on capacities of medical/surgical treatment systems to manage smoking-related illnesses. Despite findings from randomized controlled clinical trials of strong efficacy for smoking-cessation pharmacotherapies and psychotherapies, urgently needed are studies of effectiveness and feasibility in ordinary practice settings that lack personnel and other resources, to ensure treatment fidelity and adherence typical of clinical trials. In this study, effectiveness of bupropion SR, a nicotine patch, or both, co-administered with cognitive-behavioral therapy (CBT), on smoking cessation was evaluated under treatment-as-usual conditions in a primary care smoking cessation clinic. Consecutive consenting patients (n=189) self-assigned to one of three treatments (each with CBT) according to personal preference: nicotine patch (NTP; n=27), bupropion SR (B; n=101), and bupropion SR plus nicotine patch (B+NTP; n=61). Six-month self-reported abstinence rates were 14.8%, 27.7%, and 35.0%, respectively. Odds ratios for abstinence, with NTP as reference, were 2.2 for B (p=.18) and 3.1 for B+NTP (p=.06). These odds ratios are quite large, given that only active treatments were compared (no placebo arm). Resemblance of abstinence rates between this naturalistic study and the clinical trials support tentative inferences of stability and generalizability of efficacy findings to primary care settings. Further naturalistic studies of feasibility, generalizability, and sustainability of such treatments will support clinical, administrative, and policy decisions regarding prioritization of treatments under budget constraints, in a wide variety of clinical settings serving diverse populations.
Learning Objectives: 1. List the current and most effective pharmacotherapies and psychotherapies, and their combination, for smoking cessation. 2. Articulate the need and justification for naturalistic studies to strengthen the generalizability of findings from randomized controlled clinical trials of smoking cessation treatments. 3. Evaluate whether the methodological approach taken in this naturalistic study permits inference of generalizability from high-cost, high-fidelity clinical trials to usual care settings, such as primary care. 4. Apply findings in usual care settings to designing further studies of smoking treatment effectiveness in primary care and other settings that can feasibly be performed at relatively low cost. 5. Evaluate the pros and cons of using only self-report measures of smoking versus expensive biological assays. 6. Assess the inferential validity of using intent-to-treat statistical analyses versus typical treatment-completer analyses. Identify the pros and cons of different methods for imputing missing data in a longitudinal study.
Keywords: Tobacco, Smoking Cessation
Presenting author's disclosure statement:
Organization/institution whose products or services will be discussed: None
I do not have any significant financial interest/arrangement or affiliation with any organization/institution whose products or services are being discussed in this session.