This study will randomize 64 non-treatment seeking individuals who smoke cigarettes daily in a double-blind, placebo-controlled laboratory study testing the effects of cytisinicline on the neural substrates of cigarette cue reactivity.
The objective of this study is to examine the effects of cytisinicline on neural substrates of cigarette cue-reactivity. We will randomize 64 adults who smoke cigarettes daily (N=32 cytisinicline, N=32 placebo; 50% female) into a double-blind, placebo-controlled laboratory study of cytisinicline. Specifically, participants will complete a 2- to 3-week outpatient protocol that includes taking cytisinicline (3 mg, 3 times daily) or matched placebo (0 mg, 3 times daily) and completing a brief daily diary assessment of cigarette use and craving. Following 2- to 3-weeks of cytisinicline (or placebo) treatment, participants will complete a cigarette cue-exposure task during fMRI. Total study participation will be approximately 4 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
64
Targets α4β2 nicotinic acetylcholine receptors
Matched to active drug, cytisinicline
University of California Los Angeles
Los Angeles, California, United States
RECRUITINGBlood-oxygen-level-dependent (BOLD) activation to cigarette cues during fMRI task
Participants will complete a cigarette cue-exposure task during fMRI. In this paradigm, participants are exposed to videotaped cues of smoking and control, non-cigarette related, content. Blood-oxygen-level-dependent (BOLD) activation to cigarette (vs. non-cigarette control ) cues will be calculated.
Time frame: From enrollment to end of treatment at 2-to-3 weeks
In-scanner cigarette cue-induced subjective craving
In-scanner cigarette cue-induced subjective craving ratings will be obtained following each cue exposure during the fMRI task.
Time frame: From enrollment to end of treatment at 2-to-3 weeks
Subjective cigarette craving during outpatient period
Subjective cigarette craving, as assessed via daily diary self-report assessments, during the outpatient medication period
Time frame: From enrollment to end of treatment at 2-to-3 weeks
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