DOI: 10.3886/icpsr39157.v2
title: EVarQuit: Extinguishing Cigarette Smoking via Extended Pre-Quit Varenicline, Buffalo, New York, 2017-2020
title: Version 2

description: 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.
description: The primary aim of the study was to test the hypothesis that extended run-in varenicline treatment produces better smoking abstinence rates than standard varenicline therapy. The study used a substantially larger sample (N=320) to provide adequate statistical power, used cotinine levels (which reflect past-week exposure to nicotine) to provide stringent bioverification of self-reported continuous abstinence, and followed up participants for 6 months after the target quit date.
description: The study used a 2-group, balanced, randomized, double-blind, placebo-controlled, parallel-group design. Groups were distinguished by duration of varenicline treatment before the target quit date (TQD) (i.e., run-in duration). The group with extended run-in received 4 weeks of varenicline before TQD. The group with standard run-in received 3 weeks of placebo, followed by the standard 1-week pre-TQD varenicline run-in treatment. Both groups received 11 weeks of post-TQD varenicline treatment and brief quit counseling.
description: Adult smokers of combustible cigarettes who reported living within 50 miles from the University at Buffalo were recruited (beginning September 2017) through advertisements (radio, social media), recruitment databases (state Quitline, ResearchMatch.org), and a project website until the target sample size of 320 participants was enrolled. Inclusion criteria included smoking 10 or more cigarettes per day (CPD) for at least 6 months and an expired-air carbon monoxide level greater than 7 ppm at intake (to reduce exclusion of Black participants, the CPD criterion was reduced to equal or greater than 5 and the carbon monoxide criterion was eliminated in November 2019), motivation to quit smoking, and 18 to 70 years of age.
Exclusion criteria included use of other tobacco and/or nicotine products in the past 7 days or use of cessation medication in the past 14 days, lifetime diagnosis of schizophrenia or bipolar disorder, current use of antipsychotic medication, suicidal ideation in the past year, current major depression, moderate-to-severe risk of involvement with illicit or nonmedical prescription drug use, and pregnancy.
After an initial telephone screen, participants completed an intake visit, a baseline laboratory visit, and a baseline week of daily smartphone assessments. Participants made 6 clinic visits to the University of Buffalo-based research clinic. All visits included assessment of vital signs; measurement of expired-air carbon monoxide level; self-reports of smoking rate, craving, affect, withdrawal, and adverse events; and collection of a saliva sample for cotinine, 3HC, and varenicline assessment. Study medication and counseling were provided at each clinic visit.
description: Datasets: 
DS0: Study-Level Files
DS1: Public-Use Data
DS2: Restricted-Use Data
description: Treatment-seeking persons aged 18 to 70 years old smoking at least 5 cigarettes per day who reported living within 50 miles from the University at Buffalo.
description: coded on-site observation; telephone interview; web-based surveyFor additional information on the EVarQuit: Extinguishing Cigarette Smoking via Extended Pre-Quit Varenicline Study, please visit the Hawk Behavioral Health Lab website.