RecruitingPhase 2NCT06609369
Neural Mechanisms Connecting Deficient Sleep and Smoking Relapse
Sponsor
Yale University
Enrollment
114 participants
Start Date
Apr 21, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
The study aims to investigate whether behavioral interventions promote cessation in adult smokers by ameliorating negative emotions and improving self-control and identify the neural markers of these effects.
Eligibility
Min Age: 18 YearsMax Age: 50 Years
Inclusion Criteria4
- English literate
- report heavy tobacco use (including nicotine e-cigarettes) for >6 months
- meet biochemical cut off for recent cigarette smoking or e-cigarette use
- optimal body mass index
Exclusion Criteria5
- currently enrolled in other treatments
- neuropsychiatric exclusions that could interfere with study participation, increase risk of adverse events, and/or induce deficient sleep
- medical contraindications for fMRI, varenicline, and/or behavioral treatment
- factors that cause deficient sleep and for which behavioral treatment has less benefit
- women who are pregnant or nursing
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Interventions
BEHAVIORALExperimental health intervention
Behavioral health intervention
DRUGVarenicline
Days 1-3: 0.5mg once daily, Days 4-7: 0.5mg twice daily; Days 8-56: 1.0mg twice daily.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06609369
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