EVarQuit: Extinguishing Cigarette Smoking via Extended Pre-Quit Varenicline, Buffalo, New York, 2017-2020 (ICPSR 39157)
Learning theory and previous human and animal research support the hypothesis that a longer period of varenicline treatment prior to the target quit date (TQD) will lead to greater reductions in smoking before quitting, and higher long-term cessation rates, compared to standard varenicline treatment.
Building on promising preliminary clinical data, this study tested these hypotheses with a full-scale randomized clinical trial (RCT). 320 treatment-seeking adults reporting smoking at least 5 cigarettes per day (CPD) were randomized to a standard run-in group (3 weeks of placebo, followed by the standard 1 week of pre-TQD varenicline) or an extended run-in group (4 weeks of pre-TQD varenicline). Both groups received brief individual cessation counseling and 11 weeks of post-TQD varenicline.
The primary outcome consisted of cotinine-verified (at end of treatment [EOT]) self-reported continuous abstinence from smoking (in CPD) during the last 4 weeks of treatment. Secondary outcomes included bioverified self-report of continuous abstinence at the 6-month follow-up and percentage of reduction in self-reported smoking rate during the pre-quit period (week 1 vs week 4). Supplemental measures included repeated assessments of craving, withdrawal, medication adherence, and adverse events.