Actively Recruiting
Neural Mechanisms Connecting Deficient Sleep and Smoking Relapse
Led by Yale University · Updated on 2026-06-05
114
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
Y
Yale University
Lead Sponsor
N
National Institute on Drug Abuse (NIDA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying how behavioral interventions combined with varenicline medication can help adult smokers quit by reducing negative emotions and improving self-control. The study also aims to understand the brain mechanisms behind these effects and examine differences between men and women. This trial focuses on treatment-seeking adults who use tobacco or nicotine e-cigarettes heavily and experience issues with sleep. Participants will be randomly assigned to one of two behavioral intervention groups, both receiving varenicline according to a set dosing schedule starting 4 weeks before and continuing 4 weeks after a planned quit date, totaling 8 weeks of medication. They will attend weekly individual counseling sessions that include either standard care or cognitive behavioral therapy for insomnia. Sleep will be passively monitored using research-grade actiwatches. During the study, participants will have five research visits, including MRI scans at the start and at Week 4. Follow-up visits are scheduled at Weeks 8, 12, and 26. Researchers will measure cigarettes smoked per day, smoking and quit status, and days to relapse at multiple timepoints. Sleep quality and insomnia severity will also be assessed. This study is expected to continue until June 2029.
CONDITIONS
Brief Title
Neural Mechanisms Connecting Deficient Sleep and Smoking Relapse
Who Can Participate
Eligibility Criteria
You may qualify if you...
- English literate
- Heavy tobacco use or nicotine e-cigarette use for more than 6 months
- Meet biochemical criteria confirming recent cigarette or e-cigarette use
- Have an optimal body mass index
- Aged between 18 and 65 years
You will not qualify if you...
- Currently enrolled in other tobacco cessation treatments
- Neuropsychiatric conditions that interfere with participation, increase adverse event risk, or cause deficient sleep
- Medical reasons preventing use of fMRI, varenicline, or behavioral treatments
- Conditions causing deficient sleep that are less likely to benefit from behavioral treatment
- Women who are pregnant or nursing
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks before the target quit date
Participants begin taking varenicline medication and attend weekly individual counseling sessions as part of their assigned behavioral intervention.
Weekly visits for 4 weeks
Duration - 4 weeks after the target quit date
Participants continue varenicline medication and weekly counseling sessions through 4 weeks after the target quit date, alongside passive sleep monitoring with actiwatches.
Weekly visits for 4 weeks
Duration - Weeks 8, 12, and 26 after baseline
Participants attend follow-up visits to assess smoking status, sleep disturbance, and other health outcomes.
3 follow-up visits
Trial Site Locations
Total: 2 locations
1
Connecticut Mental Health Center
New Haven, Connecticut, United States, 06519
Actively Recruiting
2
Yale University
New Haven, Connecticut, United States, 06520
Actively Recruiting
Research Team
Y
Yu Chen, PhD
L
Lisa Fucito, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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