Yale study tests sleep fix to kick smoking habit
NCT ID NCT06609369
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether a behavioral sleep intervention combined with the drug varenicline can help heavy smokers quit. Researchers will measure sleep quality, smoking habits, and brain activity in 114 participants. The goal is to see if improving sleep reduces negative emotions and boosts self-control, making it easier to stay smoke-free.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Varenicline
- What this could lead to
- If successful, this could point toward a more effective smoking cessation approach that addresses sleep problems.
- What could go wrong
- This is a small Phase 2 trial, so results may not apply to all smokers. The intervention is complex and may not work for everyone.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 114 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2025
- Expected to finish
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Jun 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Locations
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Connecticut Mental Health Center
RECRUITINGNew Haven, Connecticut, 06519, United States
Contact Email: •••••@•••••
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Yale University
RECRUITINGNew Haven, Connecticut, 06520, United States
Contact Email: •••••@•••••
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