Tobacco UsePhase 2NCT06609369
Neural Mechanisms Connecting Deficient Sleep and Smoking Relapse
A Phase 2 study testing Experimental health intervention and Varenicline in people with Tobacco Use and Tobacco Cessation, run by Yale University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tobacco Use, Tobacco Cessation, Insomnia
- What is being tested?
- Experimental health intervention and Varenicline
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Apr 2025to Jun 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Connecticut Mental Health Center
New Haven, Connecticut, 06519
Yu Chen, PhD, 475-261-6153, sleepstudy@yale.edu
- Recruiting
Yale University
New Haven, Connecticut, 06520
Yu Chen, PhD, 475-261-6153, sleepstudy@yale.edu
About this study
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.
Read the detailed description
The primary objectives of this study are to compare the effectiveness of two types of behavioral interventions, when combined with varenicline medication, in promoting tobacco cessation among treatment-seeking adults and to elucidate the underlying mechanisms. The secondary objective of this study is to examine sex differences.
Investigators will recruit from two primary sources: 1) community-based recruitment strategies including web and social media ads, lay community members to recruit, and local communication channels; 2) investigators will invite referred patients to the outpatient Tobacco Treatment Service (TTS) at Yale-New Haven Hospital.
All participants will be assigned to one of two behavioral interventions. Both groups will receive treatment with varenicline and attend weekly individual counseling sessions (standard care or cognitive behavioral therapy for insomnia) and wear research-grade sleep actiwatches for passive sleep monitoring.
Participants will have a total of five expected research visits with a scheduled target quit date for Week 4. Participants will undergo MRI at baseline and at Week 4, and attend follow-ups at week 8, 12, and 26.
- Conditions
- Tobacco Use, Tobacco Cessation, Insomnia
- Being tested
- Experimental health intervention, Varenicline
- Medical subject headings
- Tobacco Use, Tobacco Use Cessation, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental health interventionBehavioural
Behavioral health intervention
VareniclineDrug
Days 1-3: 0.5mg once daily, Days 4-7: 0.5mg twice daily; Days 8-56: 1.0mg twice daily.
| Study group | Role | What they receive |
|---|---|---|
| Experimental health intervention | Experimental | Experimental health intervention and varenicline starting 4 weeks before and continuing for 4 weeks after a target quit date for a total of 8 weeks Receives: Behavioral: Experimental health intervention; Drug: Varenicline |
| Control health intervention | Active comparator | Control health intervention and varenicline starting 4 weeks before and continuing for 4 weeks after a target quit date for a total of 8 weeks Receives: Drug: Varenicline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean number cigarettes smoked per day
Mean number cigarettes smoked per day assessed by Time Line Follow Back method
Measured: Baseline, week 4, 8, 12, and 26
Smoking status
Assess expired breath carbon monoxide (CO) at baseline. CO is a standard biomarker of combustible tobacco use, is sensitive to detecting cigarette substitution, and has a typical half-life of 4 hours, and is a standard biomarker for confirming recent smoking abstinence (CO <5ppm has optimal sensitivity and specificity for biochemically verifying smoking status, including at lower smoking levels).
Measured: Baseline
Quit status
To inquire whether participants have refrained from tobacco use at each visit following their quit date. The quit status will also be verified by assessing expired breath carbon monoxide (CO). CO is a standard biomarker of combustible tobacco use, is sensitive to detecting cigarette substitution, and has a typical half-life of 4 hours, and is a standard biomarker for confirming recent smoking abstinence (CO <5ppm has optimal sensitivity and specificity for biochemically verifying smoking status, including at lower smoking levels)
Measured: Week 4, 8, 12, and 26
Days to smoking relapse
Days of resuming smoking since Week 4 schedule quit date as assessed by the Time Line Follow-back
Measured: Week 4, 8, 12, and 26
Secondary outcomes (3)
Change in PROMIS Sleep Disturbance
The PROMIS Sleep Disturbance is an 8 item self-report of perceptions of sleep quality, sleep depth, and restoration associated with sleep. Each item on the measure is rated on a 5-point scale. PROMIS measures are scored on the T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. High scores mean greater severity of sleep disturbance.
Measured: Baseline, week 4, 8, 12, and 26
Change in PROMIS Sleep-Related Impairment
The PROMIS Sleep-Related Impairment is an 8 item self-report of perceptions of alertness, sleepiness, and tiredness during usual waking hours, and the perceived functional impairments during wakefulness. Each item on the measure is rated on a 4-point scale. The score range is 4 to 32. High scores mean greater severity of sleep related impairment.
Measured: Baseline, week 4, 8, 12, and 26
Change in Insomnia Severity Index
The Insomnia Severity Index is a 7-item brief screening tool for insomnia. Each item on the measure is rated on a 5-point scale (0-4), with a total score range 0-28. High scores mean greater severity of insomnia.
Measured: Baseline, week 4, 8, 12, and 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start21 Apr 2025
- Primary completionJun 2029 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco UseStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants who smoke randomly assigned and stratified by sex and severity of tobacco dependence
- Masking
- None (open label)
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Chiang-Shan Li, Principal investigator, Yale UniversityLisa Fucito, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06609369
- Sponsor's protocol ID
- 2000037737
- Other IDs
- R01DA061285
- Status last verified
- Jun 2026
- First submitted
- 20 Sep 2024
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Mechanisms Connecting Deficient Sleep and Smoking Relapse
- ClinicalTrials.gov ID
- NCT06609369
- Acronym / sponsor ID
- 2000037737
- Conditions
- Tobacco Use, Tobacco Cessation, Insomnia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 21 Apr 2025 (actual)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 24 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The primary objectives of this study are to compare the effectiveness of two types of behavioral interventions, when combined with varenicline medication, in promoting tobacco cessation among treatment-seeking adults and to elucidate the underlying mechanisms. The secondary objective of this study is to examine sex differences.
Investigators will recruit from two primary sources: 1) community-based recruitment strategies including web and social media ads, lay community members to recruit, and local communication channels; 2) investigators will invite referred patients to the outpatient Tobacco Treatment Service (TTS) at Yale-New Haven Hospital.
All participants will be assigned to one of two behavioral interventions. Both groups will receive treatment with varenicline and attend weekly individual counseling sessions (standard care or cognitive behavioral therapy for insomnia) and wear research-grade sleep actiwatches for passive sleep monitoring.
Participants will have a total of five expected research visits with a scheduled target quit date for Week 4. Participants will undergo MRI at baseline and at Week 4, and attend follow-ups at week 8, 12, and 26.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants who smoke randomly assigned and stratified by sex and severity of tobacco dependence
| Arm | Type | Receives |
|---|---|---|
| Experimental health intervention | Experimental | Behavioral: Experimental health intervention, Drug: VareniclineExperimental health intervention and varenicline starting 4 weeks before and continuing for 4 weeks after a target quit date for a total of 8 weeks |
| Control health intervention | Active comparator | Drug: VareniclineControl health intervention and varenicline starting 4 weeks before and continuing for 4 weeks after a target quit date for a total of 8 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental health interventionBehavioral health intervention | Behavioural | Experimental health intervention |
| VareniclineDays 1-3: 0.5mg once daily, Days 4-7: 0.5mg twice daily; Days 8-56: 1.0mg twice daily. | Drug | Control health intervention, Experimental health intervention |
Primary outcome
Mean number cigarettes smoked per day
Time frame: Baseline, week 4, 8, 12, and 26
Mean number cigarettes smoked per day assessed by Time Line Follow Back method
Smoking status
Time frame: Baseline
Assess expired breath carbon monoxide (CO) at baseline. CO is a standard biomarker of combustible tobacco use, is sensitive to detecting cigarette substitution, and has a typical half-life of 4 hours, and is a standard biomarker for confirming recent smoking abstinence (CO <5ppm has optimal sensitivity and specificity for biochemically verifying smoking status, including at lower smoking levels).
Quit status
Time frame: Week 4, 8, 12, and 26
To inquire whether participants have refrained from tobacco use at each visit following their quit date. The quit status will also be verified by assessing expired breath carbon monoxide (CO). CO is a standard biomarker of combustible tobacco use, is sensitive to detecting cigarette substitution, and has a typical half-life of 4 hours, and is a standard biomarker for confirming recent smoking abstinence (CO <5ppm has optimal sensitivity and specificity for biochemically verifying smoking status, including at lower smoking levels)
Days to smoking relapse
Time frame: Week 4, 8, 12, and 26
Days of resuming smoking since Week 4 schedule quit date as assessed by the Time Line Follow-back
3 secondary outcomes
Change in PROMIS Sleep Disturbance
Time frame: Baseline, week 4, 8, 12, and 26
Change in PROMIS Sleep-Related Impairment
Time frame: Baseline, week 4, 8, 12, and 26
Change in Insomnia Severity Index
Time frame: Baseline, week 4, 8, 12, and 26
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chiang-Shan Li principal investigator
Yale University
Lisa Fucito, PhD principal investigator
Yale University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Experimental health intervention and Varenicline in people with Tobacco Use and Tobacco Cessation, run by Yale University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yu Chen, PhD (347-819-2969, yu.chen.yc838@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean number cigarettes smoked per day (time frame: Baseline, week 4, 8, 12, and 26). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.