Contingency management (CM) treatments can reduce smoking. This study will evaluate the efficacy of a short-term CM technique for initiating abstinence in conjunction with the nicotine receptor agonist/antagonist varenicline. While efficacious in reducing smoking rates, about half of patients do not respond to this pharmacotherapy, and most of the response (or lack thereof) occurs in the first month. CM is especially effective in engendering initial abstinence; if CM can improve early response to varenicline; more patients may remain on the drug and achieve abstinence, which in turn should be associated with long-term benefits. This drug may be particularly amenable for use with CM because it is purported to attenuate nicotine craving and withdrawal, two effects that do not occur with CM alone. Further, by providing CM with varenicline in a high cardiovascular risk population (patients with hypertension who smoke), benefits may outweigh costs. In total, 260 patients with pre- and stage I hypertension who smoke >10 cigarettes per day will be randomized to: varenicline alone or varenicline plus CM. Patients in both conditions will receive varenicline (titrated to a maximal dose of 1.0 mg twice daily) for 12 weeks along with standard smoking cessation therapy and regular carbon monoxide (CO) and cotinine monitoring. Patients assigned to CM will earn chances to win prizes ranging in value from $1 to $100 for each CO negative (<6 ppm) sample provided, and samples negative for cotinine will result in even greater chances to earn prizes. Main outcomes will be 7-day point prevalence rates of objectively confirmed abstinence at weeks 5, 12, 24, 36, and 52, longest duration of continuous abstinence, and percent continuously abstinent. A significantly higher proportion of CM patients are expected to achieve and maintain long durations of abstinence than patients receiving varenicline alone. Although some relapse is likely to occur after treatment, slopes of the relapse curves are not expected to differ between groups, such that the group that receives CM early on should have a higher proportion of patients abstinent at week 52. Clinic and 24-hour blood pressure (BP) and heart rate (HR) will be additional outcomes. We expect that BP and HR will decrease more among CM than non-CM patients and reductions in smoking may mediate decreases in these indices. ? ? ?
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