Investigating how sleep affects smoking cessation
Official title: Neural Mechanisms Connecting Deficient Sleep and Smoking Relapse
Run by Yale University · NCT06609369 · Data updated 2026-11-12
This study is testing whether improving sleep can help adults trying to quit smoking stay smoke-free longer by comparing two different support methods.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 114 (estimated) |
| Sponsor | Yale University Academic / other |
| Locations | 2 sites (New Haven, Connecticut and 1 other locations) |
| Status | Recruiting |
| Started | April 21, 2025 |
| Main results expected | June 2029 |
| Study ends | June 2029 |
| Registry record updated | June 5, 2026 |
| Trial ID | NCT06609369 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults who are heavy tobacco users and have been smoking for over a year, seeking help to quit.
✕Probably not a fit
Patients currently enrolled in other treatments or with neuropsychiatric conditions that interfere with study participation may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to explore the connection between sleep quality and smoking relapse by comparing two behavioral interventions combined with varenicline medication in adults seeking to quit smoking. Participants will be assigned to either standard care or cognitive behavioral therapy for insomnia, and will receive weekly counseling sessions while wearing sleep monitoring devices. The study will also utilize MRI scans to identify neural markers associated with these interventions and assess potential sex differences in outcomes. Participants will have multiple visits over a 26-week period to evaluate the effectiveness of the interventions.
Why it matters
Potential benefit: If successful, this study could lead to improved strategies for smoking cessation by addressing sleep-related issues.
How similar studies have gone: Other studies have shown promising results in using behavioral interventions for smoking cessation, but this specific approach focusing on sleep is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Connecticut Mental Health Center
New Haven, Connecticut, United States Recruiting -
Yale University
New Haven, Connecticut, United States Recruiting
Study contacts
- Principal investigator: Chiang-Shan Li — Yale University
- Study coordinator: Yu Chen, PhD
- Email: yu.chen.yc838@yale.edu
- Phone: 347-819-2969
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.