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Recruiting Phase 2 NCT06609369

Neural Mechanisms Connecting Deficient Sleep and Smoking Relapse

Trial Parameters

Condition Tobacco Use
Sponsor Yale University
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 114
Sex ALL
Min Age 18 Years
Max Age 50 Years
Start Date 2025-04-21
Completion 2029-06
Interventions
Experimental health interventionVarenicline

Brief 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 Criteria

Inclusion Criteria: * 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 Criteria: * 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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