EVarQuit: Extended Pre-quit Varenicline to Assist in Quitting Smoking
Status:
Recruiting
Trial end date:
2021-08-01
Target enrollment:
Participant gender:
Summary
Varenicline is the most effective smoking cessation therapy available. Nevertheless, most
smokers using varenicline relapse within the first few months after quitting. Varenicline is
hypothesized to help smokers to quit in part by reducing the reinforcing effects of smoking
during the standard 1-week pre-quitting treatment phase. 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, the study tests these hypotheses with a
full-scale randomized clinical trial (RCT). 320 treatment-seeking smokers will be 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 will
receive brief individual cessation counseling and 11 weeks of post-TQD varenicline. The
primary outcome measure will be bio-verified continuous abstinence at end-of-treatment (weeks
8-11 post-quit; cessation at 26-weeks post TQD will also be examined. Hypothesized mediating
mechanisms (e.g., smoking reinforcement) will be evaluated by behavioral, physiological, and
subjective measures assessed both in the lab and using real-world, real-time electronic
momentary assessments (EMA). The investigators predict that long-term, bio-verified smoking
cessation will be improved among the extended run-in group compared to the standard run-in
group. The investigators further predict the improved clinical outcomes with extended run-in
varenicline will be explained (or mediated) by greater pre-quit reductions in smoking
reinforcement among the extended run-in group compared to the standard run-in group. The
significance of this work is clear: The project aims to make best available treatment for
smoking cessation even better, using a method that is ripe for dissemination and an approach
that will elucidate critical mechanisms to target in the next generation of treatment
enhancement.