RecruitingPhase 2

Neural Mechanisms Connecting Deficient Sleep and Smoking Relapse

United States114 participantsStarted 2025-04-21

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Mean number cigarettes smoked per day

Timeframe: Baseline, week 4, 8, 12, and 26

Smoking status

Timeframe: Baseline

Quit status

Timeframe: Week 4, 8, 12, and 26

Days to smoking relapse

Timeframe: Week 4, 8, 12, and 26

Trial details

NCT IDNCT06609369

SponsorYale University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-06

Contact for this trial

Yu Chen, PhD

347-819-2969 yu.chen.yc838@yale.edu

View on ClinicalTrials.gov More Tobacco Use trials

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.