Status:
RECRUITING
Neural Mechanisms Connecting Deficient Sleep and Smoking Relapse
Lead Sponsor:
Yale University
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Tobacco Use
Tobacco Cessation
Eligibility:
All Genders
18-50 years
Phase:
PHASE2
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 ...
Detailed Description
The primary objectives of this study are to compare the effectiveness of two types of behavioral interventions, when combined with varenicline medication, in promoting tobacco cessation among treatmen...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 21 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2029
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT06609369
Start Date
April 21 2025
End Date
June 1 2029
Last Update
June 13 2025
Active Locations (2)
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1
Connecticut Mental Health Center
New Haven, Connecticut, United States, 06519
2
Yale University
New Haven, Connecticut, United States, 06520