Neural Mechanisms Connecting Deficient Sleep and Smoking Relapse
Start Date
4/21/2025
Completion Date
6/1/2029
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.
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 treatment-seeking adults and to elucidate the underlying mechanisms. The secondary objective of this study is to examine sex differences. Investigators will recruit from two primary sources: 1) community-based recruitment strategies including web and social media ads, lay community members to recruit, and local communication channels; 2) investigators will invite referred patients to the outpatient Tobacco Treatment Service (TTS) at Yale-New Haven Hospital. All participants will be assigned to one of two behavioral interventions. Both groups will receive treatment with varenicline and attend weekly individual counseling sessions (standard care or cognitive behavioral therapy for insomnia) and wear research-grade sleep actiwatches for passive sleep monitoring. Participants will have a total of five expected research visits with a scheduled target quit date for Week 4. Participants will undergo MRI at baseline and at Week 4, and attend follow-ups at week 8, 12, and 26.
Eligibility Criteria
Age Range: 18 years to 65 years
Interventions
Experimental health intervention
Varenicline
Conditions
Locations
Connecticut Mental Health Center
New Haven, Connecticut 06519
United States
Yale University
New Haven, Connecticut 06520
United States