The goal of this study is to assess varenicline vs. placebo for its effect on decreasing cue reactivity in light and intermittent smokers.
The study will consist of randomization to receive either varenicline or placebo over 6 weeks and include 5 study visits. Participants are offered an optional additional 6 weeks of active varenicline. Cue reactivity will be assessed in both a lab-based setting (viewing series of images and rating cravings) and in a real-world setting (text-based daily interaction).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
11
Chantix
Placebo
Duke University
Durham, North Carolina, United States
Change in Self-Reported Craving Level Via Lab-Based Cue Reactivity
Participants were asked to self-report craving level to smoke on a scale of 1-10 with 1 corresponding to no craving and 10 corresponding to intense craving. Self-reported craving level was requested following presentation of multiple images on a screen over a 20 minute period. Four types of images were presented - neutral affect, negative affect, smoking and social images.
Time frame: Baseline, Visit 4 (week 6)
Change in Self-Reported Craving Level Via Real-World Cue Reactivity
Craving level in "real world" situations was assessed through electronic momentary assessment (EMA). Participants were instructed to send a text to the study team each time they experienced craving to smoke a cigarette. Self-report craving level to smoke was reported on a scale of 1-10 with 1 corresponding to no craving and 10 corresponding to intense craving.
Time frame: Baseline, Visit 4 (week 6)
Changes in Smoking
7-day point prevalence smoking abstinence. This will be measured through self-reported daily smoking diaries and daily text messaging.
Time frame: Screening visit, Visit 4 (week 6)
Medication Adherence
Medication adherence is measured by composite self-reported diaries and daily text messaging responses.
Time frame: Screening visit, Visit 4 (week 6)
Medication Tolerance by Self-Reported Side Effects
Self-reported side effects (open ended survey questions) with a ranking scale of 1-2 (mild), 3-5 (moderate), and 6-7 (severe). Any side effect 3 or greater will be reviewed by a study medical provider.
Time frame: Up to 12 weeks
Changes in Smoking Abstinence
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7-day point prevalence smoking abstinence confirmed by CO \<7ppm. This will be measured through biochemical confirmation (CO breath test).
Time frame: Screening visit, Visit 4 (week 6)