Investigating how sleep affects smoking cessation
Neural Mechanisms Connecting Deficient Sleep and Smoking Relapse
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 |
| Enrollment | 114 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | Yale University Academic / other |
| Locations | 2 sites (New Haven, Connecticut and 1 other locations) |
| Trial ID | NCT06609369 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults who are heavy tobacco users and have been smoking for over a year, seeking help to quit.
Not a fit: Patients currently enrolled in other treatments or with neuropsychiatric conditions that interfere with study participation may not benefit from this study.
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 performed: Other studies have shown promising results in using behavioral interventions for smoking cessation, but this specific approach focusing on sleep is relatively novel.
Eligibility criteria
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 this trial is running
New Haven, Connecticut and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.